Master Classes

Continuous Manufacturing Processes for Biotechnological Products MasterClass

Continuous Manufacturing Processes for Biotechnological Products MasterClass

Online MasterClass | 16 & 17 June, 2021

The environment for recombinant proteins used as biotherapeutics is changing. In the context of developing new biological entities, the bioindustry should further improve speed to clinic, gain in manufacturing flexibility while reducing costs of good sales (COGS).

Despite at start of the recombinant era in the 80s/90s, continuous upstream processes have been applied especially for sensitive molecules such as hormones, cytokines and blood factors, the development of monoclonal antibodies as drugs was mainly based on large-scale fed-batch upstream connected to chromatography-based purification operated in batch. However, since the last ten years, it seems that the productivity of manufacturing processes of recombinant proteins based on large-scale fed-batch and classical chromatography processes has reached a plateau. As new technologies in cell separation and automatization of chromatographybased processes emerged, continuous manufacturing becomes a valid option for improving manufacturing productivity, flexibility and COGS.

Whereas continuous manufacturing is now well considered for small molecules, it is not yet the case for biologics. Despite, some challenges still exist in applying continuous manufacturing processing for biologics, that approach could address some of the current limitations of largescale fed-batch processes.

New Global Mobility and Remote Assignments MasterClass

New Global Mobility and Remote Assignments MasterClass

Online MasterClass | 01 & 02 July, 2021

International assignments can be physical or remote. This course has been designed to equip HR professionals to understand and effectively support business and talent outcomes, when moving talent or work across borders. Traditional expatriate assignments, permanent transfers, localization and local employment of foreign talent will be covered, from both global and local perspectives. Virtual/remote international assignments and their risks will be examined in light of recent trends.

Analysing and Drafting Commercial Contracts in Life Sciences MasterClass

Analysing and Drafting Commercial Contracts in Life Sciences MasterClass

Online MasterClass | 02 & 03 August, 2021

This 2-day intensive programme is aimed at participants who wish to understand the various legal and practical aspects of commercial contracts in its different facets, and minimise their organisation to exposure to potential expensive disputes, it addresses the background law, key documents including the Joint Venture Agreement, R&D Agreement, Commercial Manufacturing Agreement, Collaboration structures, intellectual property. Sample documents will be shared with the participants to study themselves and refer back to them to continue their learning after the course.

Digitalization Compensation & Benefit Processes MasterClass

Digitalization Compensation & Benefit Processes MasterClass

Online MasterClass | 12 & 13 August, 2021

The increasing demand for digitalization is currently challenging large to small sized company globally and hardly any company can ignore the digitalization trends today. This masterclass will provide delegates clarity of which prerequisites need to be considered to prepare for the demanding task. This course will provide examples to digitalization mysteries in compensation management. The Advanced Masterclass “Fit for HR Compensation & Benefits Digitalization” primarily aims to support experienced business and HR professionals who are direct or indirect responsible for the implementation of digital projects and initiatives. It provides concrete recommendations for action and transparency with regards to the implementation of digital projects. By discussing best practice approaches and recommending iterative procedures, delegates will be empowered to act on an equal footing with decision-makers and consultants in the digitalization process. Often, the biggest challenge is that the focus lays on the software packages. However, it is way more important to analyze and focus on those processes which need to be digitized first. These processes must be optimized first before new target processes will be developed and be mapped accordingly in the software. Remember: By simply applying a software solution to out-of-date processes which operate poorly will lead to inferior results and could decrease efficiency. The two-day workshop will focus on four main parts:

  • HR CB Data Management / System design
  • HR CB Processes
  • HR CB Policies / Guidelines
  • Communication, Change and Training Management
Pharma Contract Drafting MasterClass

Pharma Contract Drafting MasterClass

Online MasterClass | 30 & 31 August, 2021

The Contract and legal document drafting seminar is an intensive training event for lawyers, and paralegals,working in the the pharmaceutical industry, held over 4 consecutive half-day sessions. It will improve participants’ skills of writing clear, concise contracts with specific relevance to the pharmaceutical Industry, including collaborative research agreements, joint-venture agreements, IP rights and key issues in commercial manufacturing agreements for medicines and vaccines.

The seminar will cover not only the practical knowledge needed by lawyers working in international commerce but will also simulate an international contract negotiation scenario, with teams and simulated strategy meetings, as well as tactical argument development.

The trainer is a British lawyer, used to the multicultural, international flavour of modern business, who is also a qualified lawyer/linguist, and the chief training partner/instructor of the UN for contracts and contract drafting.

VBA & Innovative Contracting in Pharma MasterClass

VBA & Innovative Contracting in Pharma MasterClass

Online MasterClass | 23 - 25 August, 2021

As healthcare shifts from “volume to value” we are seeing a global trend of shifting medicines and technology pricing towards a value based paradigm. This comprehensive symposium will cover off “value based agreements” and innovative financial contracts between pharmaceutical manufactures and payers. We will go through VBA nomenclature through to design and architecture of value based agreements across different drug types, therapy areas and payer archetypes. There will be case presentations of successful VBA from across the globe, focusing on US & EU markets, with market analysis and deconstruction of these agreements. There will be a focus on “why do a VBA” and key drivers from manufacturers and payers to ensure success for all parties for access and reimbursement with innovative contracting mechanisms. Finally, we will explore how pharmaceutical manufacturers are undertaking organizational change as they move up the VBA adoption curve and improve resource and x-functional team working. To support successful deployment and scalability of VBA’s across in market and pipeline portfolio products.

Manage the Annual Salary Review MasterClass

Manage the Annual Salary Review MasterClass

Online MasterClass | 06 & 07 September, 2021

Every compensation & benefits manager must know how to manage the annual salary review, and less experienced C&B specialists also must be able to support it. This course equips C&B professionals to competently perform their most important annual project, the annual salary review. The course covers pay for performance theories, salary budgeting, use of market data for midpoint updates, merit matrix development, developing a manager worksheet, rolling up manager submissions for next level review, project management, facilitating approvals, and effective communication practices. The course focuses on skills, using fictitious data. Participants will bring their laptops and practice what is taught.

Advanced Precision Medicine MasterClass

Advanced Precision Medicine MasterClass

Online MasterClass | 07 & 08 September , 2021

Healthcare landscape is changing drastically due to the emergence of new technologies. Treatment is diverging from the general applications paradigm we were subjected in the past
to a personalization for each patient and each disease type. This course will present a general overview on precision medicine with several case studies of the newest aprroaches in different
medical areas. Additionally, it will include some important aspects of digital health and medical artificial intelligence, to provide a complete set of tools to understand any project of moderm
medical affairs.

Fraud Prevention, Detection and Investigation MasterClass

Fraud Prevention, Detection and Investigation MasterClass

Online MasterClass | 08 & 09 September, 2021

How would you know if fraud was occurring in your organisation? Does your organisation have a fraud prevention strategy? Do you have a formal programme to tackle the risk posed by fraud? Do you have the use of any automated fraud detection techniques? If fraud is suspected do you have a clearly defined approach for managing the investigation? This course will help you significantly enhance your approach in all these key areas.

Pharma Mergers and Acquisitions MasterClass

Pharma Mergers and Acquisitions MasterClass

Online MasterClass | 02 & 03 September, 2021

• Takes participants through the whole legal process focusing on key legal and practical challenges for the constituent players

• Share the facilitative trainers unique tried and tested 10 Key Step Analysis to analyse any M & A contract

• Attended by financial and legal professionals, entrepreneurs as well as analysts

• Provides sample legal documents to back up the presentation materials • Shares the trainers experience of being a Non Executive Director of an AIM listed international company, and member of its Audit and Investment Committees

• Trainers experience of transactions as a former partner of KPMG

• Interactive workshops

• Addresses and clarifies the different types of warranties and due diligence in Life Sciences investment

Advanced CMC MasterClass

Advanced CMC MasterClass

Online MasterClass | 14 & 15 September, 2021

Technical and regulatory requirements for developing a medicinal product are becoming stricter every day, the products themselves become more and more complex. This course will present key points in CMC which are currently the focus of Health Authorities, and which are critical for a successful developement, registration, and lifecycle of pharmaceutical products. The course covers general requirements for small molecules and biologics.

How to submit variations in Europe MasterClass

How to submit variations in Europe MasterClass

Online MasterClass | 16 September, 2021

Variations are an essential part of pharmaceutical products lifecycle and a critical milestone for the management of post-approval changes. Regulation worldwide is not yet harmonised and this course will help you understand the specific legal framework of variations in Europe. Through practical examples and exercices, you will learn to define the best submission strategy, evaluate the documents to prepare and understand the challenges of implementing changes.

Pharmacovigilance on the Internet and Social Media MasterClass

Pharmacovigilance on the Internet and Social Media MasterClass

Online MasterClass | 14-16 September, 2021

The direct interaction between patients/users of pharmaceutical products and the Pharmaceutical Companies has had a big increase since the widespread use of the Internet and social media. In parallel, the requirements of the competent authorities towards the exhaustive collection and management of any adverse events related to the products marketed by the Marketing Authorisation Holders (MAH) are becoming more and more tight in order to better guarantee that the safety of the patients using the products is the highest standard. As an additional fact, the use of social media and the Internet have brought to game table agents that were not used to fulfill or to even know the pharmacovigilance standards required to the Pharmaceutical Industry. As a result of this the role of Pharmacovigilance has become key to correctly address a series of activities (electronic surveys, chats, chatrooms, etc.) and players (Product Managers, Communications Managers, Community Managers) in order to guarantee that all Legal requirements are met.

H&S Legal Compliance and Leadership MasterClass

H&S Legal Compliance and Leadership MasterClass

Online MasterClass | 15 & 16 September, 2021

Many companies and their directors / senior individuals may not be fully familiar with their Health and Safety duties and the way in which changes to Health & Safety legislation (both in the UK and abroad)might impact them. This highly engaging and interactive seminar will highlight the key health and safety risks for companies and its individuals - and discuss how to limit liability and exposure to the risk of prosecution. You will also get the chance to participate in an ‘mock’ interview under caution by an enforcing authority and the workshop session will allow you to discuss and analyse how best to deal with an investigation into a Health and Safety incident, without putting your company and yourselves at risk.

CAPA and Root Cause Analysis MasterClass

CAPA and Root Cause Analysis MasterClass

Online MasterClass | 21 & 22 September, 2021

In today’s highly regulated pharma, biotech, device and animal health industries, it is essential to use the most efficient processes and ensure compliance with an active corrective and preventive action (CAPA) and RCA system.

This course will cover CAPA and RCA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and RCA planning and implementation in practice of improvements.

Root cause analysis is the process by which we discover the underlying cause of difficulties in a business process or processes. Often businesses waste a great of money in fixing the symptoms of a problem, rather than the problem itself.

CAPA and RCA procedures are a frequent focus of regulatory inspectors and evidence will be required at any future inspections that CAPA actions have been implemented.

In this two-day course, participants learn to apply a systematic end-to-end process for analysing problems to uncover their root cause.

Building Digital Health Solutions MasterClass

Building Digital Health Solutions MasterClass

Online MasterClass | 23-24 September, 2021

Digital health has grown exponentially as governments and other payers grapple with how to provide the best possible health outcomes at affordable costs. We believe that every healthcare decision should be informed by the best scientific research derived from rigorous, proven methodologies. In today’s world, healthcare decision makers across the globe are often faced with the need to select therapeutic “interventions” from multiple treatment options, including biopharmaceuticals, medical devices, healthcare services and digital solutions. Understanding the digital health ecosystem is the beginning of the journey to build a successful solution. We will clarify which stakeholders are involved, which kind of products we can build and how to do it, why to make great partnerships and how to identify the value proposition for a sustainable business model. In this masterclass we will work on our 6 building blocks system to develop a digital health product. We will see the latest movements in the market, and the main diseases where digital products start to offer real success. We will clearly transit to a different way of working, in a more agile way. We will identify the risks and opportunities in the different phases of development, from the discovery phase to the development phase passing by clinical, regulatory, and go to market.

Critical Quality Attributes of Recombinant Proteins for Therapeutic Use MasterClass

Critical Quality Attributes of Recombinant Proteins for Therapeutic Use MasterClass

Online MasterClass | 23 & 24 September, 2021

The introduction of the Quality by Design concept in the early 2000’s has changed the paradigm of product and process development for recombinant biotherapeutics, switching from the process makes the product to the product makes the process. The Quality by Design approach starts by the understanding of the impact of changes in quality attributes on product clinical efficacy and safety. Without understanding it, it is difficult to develop a manufacturing process that would have to consistently deliver a product of the desired quality. Therefore, it is important to understand the quality attributes possibly generated by the manufacturing process (process-related impurities), the intrinsic heterogeneity of recombinant proteins, the post-translational physical and chemical modifications, and their risks for the patients. The Master Class on critical quality attributes of recombinant proteins for therapeutic use will address the understanding of quality attributes, the purpose of assessing their criticality and how to select critical quality attributes. The Master Class will be illustrated by a review of physico-chemical variants, process- and product-related impurities and their impact on the product efficacy and safety.

Unlocking the Potential of Cell & Gene Therapies MasterClass

Unlocking the Potential of Cell & Gene Therapies MasterClass

Online MasterClass | 23 & 24 September, 2021

Nowadays, for as much as 95% of the 7 000 to 10 000 rare diseases that exist, there are no approved therapies. Of the estimated 400 M people worldwide afflicted with a rare disease, 50% are children. Cell and gene therapies have emerged as a new treatment paradigm for many rare diseases. These novel medicines have the potential to provide long-term therapeutic benefits for patients, however their development is both risky and cost intensive. As of the end of 2020, there were 1220 ongoing regenerative medicine and advanced therapy clinical trials and 1085 gene- and cell-based therapeutics companies working worldwide to develop therapies. These companies raised a cumulative amount of $19.9 B in 2020, a two times increase from $9.8 B in 2019. The number of investigational new cell and gene therapy drug applications has tripled in the last three years. Obtaining better insights into the specific technological, clinical and commercial challenges is crucial to ensure advances of this emerging field. Implementation of innovative clinical research methodologies, current and future focused pricing models and ‘up-to-date’ regulatory approval paths constitute interlocked parts towards long term value creation of these novel, curative therapies. Assessing innovative business models and partnerships will enable acceleration of commercialization processes and guarantee timely patients’ access.

Effective Remote Internal Auditing MasterClass

Effective Remote Internal Auditing MasterClass

Online MasterClass | 30 September & 01 October, 2021

The last year has seen even more internal auditors and review teams adapt to the realities of working remotely. We have had to conduct business-critical internal audit engagements and reviews while working away from our desks, distant from our clients and from our management.

These engagements may have been part of the annual or periodic plan, but may still be so important that even in the current pandemic, you must successfully deliver them. They could also be new assurance or consultancy engagements thatthe pandemic has prompted. In either case, carrying them out remotely imposes new ways of working - and thinking.

Three essential elements - communication skills, internal auditing tools and our core internal auditing principles - are little different from what you are used to undertaking. It’s all about adjusting them to work when conducting an engagement remotely. In an uncertain and challenging environment, organisations expect internal audit to go beyond reviewing historical activity and assessing low value transactions.

Our key stakeholders require internal audit engagements that are insightful, forward looking, and go beyond simply preserving value to creating value for the organisations. This course will show you how to provide effective, professional insight and internal audit assurance while working remotely, enabling you to deliver engagements, deliver the plan and deliver the insight our boards need.

Synthetic biology & Biopharma – a unique platform for growth and sustainable future MasterClass

Synthetic biology & Biopharma – a unique platform for growth and sustainable future MasterClass

Online MasterClass | 18 & 19 October, 2021

The global synthetic (constructive) biology market is anticipated to reach $30.3 B by 2027 growing at a CAGR of 23.6% during the last 7 years of the investigated period. Private investment in startups is increasing rapidly and added up to over $12 B in the last decade. In 2018, synthetic biology companies raised a total amount of $4.2 B, a two times increase in comparison to the previous year. Synthetic biology finds its inventory applications in several industrial sectors including healthcare, food and agri-tech, tools & services, biomaterials & green chemicals. Its impact on the biopharmaceutical industry is constantly growing enabling novel, better therapies for patients based on gene editing, genetic and metabolic engineering, and computational design, to name a few. To de-risk the target scale operations, platform-based business models are nowadays more frequently leveraged. Emerging technologies trigger the enhancement of sustainable production ways utilizing microbiome fermentation processes, 3D printing, automation, and AI. This masterclass will shed light on various emerging technologies arising from the synthetic/ engineering biology field. Alternative solutions to nowadays challenges, enabling swift development and commercialization of antibodies, bio-therapeutics, precision medicine and accompanying diagnostic tools will be granularly analysed based on cost reduction, innovative business models and impact investment opportunities.

Advanced Nanotechnology in Medicine MasterClass

Advanced Nanotechnology in Medicine MasterClass

Online MasterClass | 07 & 08 October, 2021

The global nanomedicine market was reported to be worth $70 billion by 2011, $140 billion in 2016 and is predicted to be worth $350 billion by 2025. To take advantage of the many opportunities that lie ahead and to be successful in a market that will become more and more competitive requires an understanding of the scientific, technological, clinical, regulatory, financial and commercial challenges that apply to this field. This master class aims at describing this evolving scenario and to empower business executives and R&D expert with the necessary knowledge to navigate the entire pathway of developing, testing and commercialising new products based on nanoscale materials and to introduce them to regulatory issues, intellectual property and financing. The topics presented in this master class will provide participants with the breadth of understanding necessary to evaluate the current state of nanotechnology as well as introducing the implications of this new field in the framework of healthcare and medicine. The aim is to empower participants with the fundamental knowledge that will enable them to evaluate strategic and tactical issues and to develop problem-solving skills in the exciting and emerging discipline of nanomedicine. Finally, the master class will discuss how to progress this area to meet the future needs of the field by introducing to the participants diagnostics, therapeutics, vaccines, implants and biosensors that have the potential to revolutionise health care.

The EU Clinical Trial Regulation MasterClass

The EU Clinical Trial Regulation MasterClass

Online MasterClass | 21 & 22 October, 2021

The new EU Clinical Trial Regulation (536/2014) will replace the European Clinical Trials Directive (2001/20/EC) in 2022. Key aims of the new Regulation are to harmonise procedures for carrying out clinical trials across the EU and to simplify the clinical trial approval dossier by submission through a new clinical trial database and portal. Guidelines for enacting the new Regulation have also been prepared in a number of areas including inspection, investigational medicinal products and trial documentation. This course will provide an essential understanding to help with compliance with the new Regulation and associated implementing acts and other texts for carrying out clinical trials in the EU. The programme will highlight the most important of these key requirements and changes and how these are likely to impact on trials for biopharmaceutical companies, vendors and study sites.

US Healthcare & Smart Pharma Packaging - Regulations & Technical MasterClass

US Healthcare & Smart Pharma Packaging - Regulations & Technical MasterClass

Online MasterClass | 12-14 October, 2021

The training course will support you in collecting, sorting and proper understanding of the requirements of pharma and healthcare packaging, the US Healthcare and Pharma Market, the global serialization requirements in the US, in Brazil, Russia, Europe and other markets and the technical implementation at the pharmaceutical manufacturer. This course will deal with Child Resistant packaging, with Smart packaging and will cover tamper evident packaging and the qualification of tamper verification features on healthcare packaging. This course will cover Artwork Security and Audit Trails of Artworks Management, packaging to Improve Patient Compliance. The course will focus on checks and controls in packaging operations and a section of cross functional and special US pharma packaging topics.

Advanced Genome Editing MasterClass

Advanced Genome Editing MasterClass

Online MasterClass | 14 & 15 October, 2021

Genome editing has revolutionized our ability to modify the genome of (quite) any biological organism. In particular, it opens up new possibilities for the treatment of various diseases in humans like rare genetic diseases, cancer or HIV. Today, what alterations can we really achieve? What risks can we anticipate and how to check for unwanted mutations? This course is based on the knowledge acquired on animal and cell models and describes how they can inform us of the potential consequences of genome editing for preclinical research and therapeutic approaches. It is designed for researchers who are already familiar with genome editing technologies basics. It aims to provide validation leads for scientists who create animal models by genome editing or who want to develop therapeutic approaches.

The Future of Internal Audit MasterClass

The Future of Internal Audit MasterClass

Online MasterClass | 14 & 15 October, 2021

The Internal audit function is increasingly regarded as a business partner, a catalyst for change and a Governance advisor. You therefore need your internal audit function to become a trusted advisor and internal consultant. The course represents a superb opportunity to develop new approaches to the difficult challenges facing modern audit functions and also provides the platform to focus the key role of IA to this fast changing world.

The OECD Principles of Good Laboratory Practices (GLP) MasterClass

The OECD Principles of Good Laboratory Practices (GLP) MasterClass

Online MasterClass | 16 & 18 November, 2021

The understanding, development, implementation, follow-up and improvement of the GLPPrinciples is fundamental for the application of non-clinical health and environmental safety studies. The GLP Principles are mandatory for non-clinical safety testing of test items in pharmaceutical products, pesticide products, cosmetic products, veterinary drugs as well as food additives, feed additives, and industrial chemicals and other products as required by national regulation or legislation.

The organization of this GLP Training Course exists of presentations, questions and answers. The GLP workshop is an advanced GLP training course where it is recommended that participants have a basic knowledge and experience of the OECD GLP Principles to follow successfully this training course.

Advanced CMC MasterClass

Advanced CMC MasterClass

Online MasterClass | 22-24 November, 2021

Technical and regulatory requirements for developing a medicinal product are becoming stricter every day, the products themselves become more and more complex. This course will present key points in CMC which are currently the focus of Health Authorities, and which are critical for a successful developement, registration, and lifecycle of pharmaceutical products. The course covers general requirements for small molecules and biologics.

Methodology

The participants will gain knowledge via lecture-type sessions, letting substantial time for Q&A and discussions. Furthermore the training places great emphasis on practical examples through case studies.

Advanced CMC MasterClass

Advanced CMC MasterClass

Online MasterClass | 20-21 October, 2021

Technical and regulatory requirements for developing a medicinal product are becoming stricter every day, the products themselves become more and more complex. This course will go through the key scientific points for the development and registration of your medicine, and provide a focus on US FDA and Europe expectations for CMC. The course covers general requirements for small molecules and biologics.

Methodology

The participants will gain knowledge via lecture-type sessions, letting substantial time for Q&A and discussions. Furthermore the training places great emphasis on practical examples through case studies.

Advanced ESG: Principles and Practice MasterClass

Advanced ESG: Principles and Practice MasterClass

Online MasterClass | 11 & 12 November, 2021

Environmental, Social, Governance (ESG) investing is gaining traction as mainstream players are now considering the financial and risk management benefits of adhering to some form of ESG integration and monitoring, while at the same time find the need to respond to the increasing demand forresponsible investments that come from millennials and the need to comply with new regulation. ESG Principles & Practice will provide insights on whatis ESG, why does it matter and whatis the impact of ESG integration on investment decisions. It will also delve into alternative ESG integration methodologies, explore current ESG trends, challenges faced in measurement and reporting, and explore the differences between ESG and impact investing.

All you need to know to generated a valuable genetically engineered model MasterClass

All you need to know to generated a valuable genetically engineered model MasterClass

Online MasterClass | 04 & 05 November , 2021

In this MasterClass, the different steps that are requiered to generate a pertinent genetically engineered model will be detailed and explained. What is the purpose of a specific design? What does a conditional model mean? Is it better to fuse a reporter in N- or C-term of a protein? Should we use IRES (Internal Ribosome Entry Site) rather than 2A peptides when we need to coexpress two proteins under the same promoter. What sequences are required? The course will be largely illustrated with mouse and rat model examples and also cellular models. Case studies will illustrate the cours. A time for discussion and question will be left to participant. The advantages and inconveniences of using genome edition (focusing on CRISPR/Cas9 approaches) versus standard homologous recombination will largely be discussed.

Advanced E-Pil and E-Leaflet MasterClass

Advanced E-Pil and E-Leaflet MasterClass

Online MasterClass | 11 & 12 November, 2021

Electronic delivery of Patient Information (e-PIL) and leaflets (e-leaflets) is becoming increasingly important in providing patients and medical staff with product data. A number of Regulatory Authorities now permit and indeed encourage this delivery mechanism and others are soon to follow suit. Organisations that prepare early will be able to actively leverage the benefits sooner, be seen as ‘early adopters’ and innovators that others will seek to follow. This course will provide the attendee with the building blocks for the establishment and delivery of an e-PIL strategic initiative identifying where the organisation may be most significantly impacted.

Process Validation for Biotechnological Products MasterClass

Process Validation for Biotechnological Products MasterClass

Online MasterClass | 18 & 19 November, 2021

Manufacturing processes should be validated prior to initiate commercial manufacturing. Regulatory bodies expect that the manufacturer understand the process so that quality, safety and efficacy of the product are designed or built into the product through the appropriate control of each manufacturing process steps. Today, process validation comprises three main steps: (1) Stage 1 – Process Design (FDA) or Process Evaluation (EMA); (2) Stage 2 – Process Qualification (FDA) or Process Verification (EMA); and (3) Continued Process Verification (FDA) or On-going Process Verification (EMA). The training aims to provide deeper understanding on how process validation for biotechnological processes, which is the collection and evaluation of data from the process design stage through commercial production, would be appropriately designed and executed to establish scientific evidence that a manufacturing process is capable of consistently delivering quality product.

CMC Readiness Challenge in case of Expedited Programs for Biotechnological Products MasterClass

CMC Readiness Challenge in case of Expedited Programs for Biotechnological Products MasterClass

Online MasterClass | 25 & 26 November, 2021

To ensure that therapies for serious conditions are approved and available to patients as soon as it can be concluded that the therapies’ benefits justify their risks, regulatory agencies have developed specific processes to speed the availability of new therapies, especially when there are no satisfactory alternative therapies, while preserving appropriate standards for safety and effectiveness.

As expedited development does not lessen the quality expectations, one challenge is to provide adequate Chemistry, Manufacturing and Controls (CMC) information required to support a marketing authorization of a biological product on a timely manner. An accelerated clinical development program is usually a prerequisite for acceptance onto an accelerated access scheme project. This decreases the amount of time available for the development and understanding of the drug substance, the drug product and their associated processes and analytical methods. Therefore, there must be a strategy to ensure that the critical aspects of CMC provide assurance that safety and quality are not compromised. This strategy must also assure the flexibility needed to deliver consistent and reliable supplies of product to patients in a less predictable environment.

Early access approaches create challenges to complete quality and manufacturing development and data requirements during development of products. They require the manufacturing organization to reconsider traditional approaches to product and process development and undertake their own resource-intensive, cross-functional team approach to ensure a sustained supply of safe and efficacious product at the time of approval. The Master Class will delineate potential adaptations to the traditional approach to product development, product characterization, specification setting, process validation, stability setting, manufacturing and timepoint for full completion of certain quality data packages.

Safety Data Exchange Agreements (SDAEs) and PV Arrangements with External Vendors MasterClass

Safety Data Exchange Agreements (SDAEs) and PV Arrangements with External Vendors MasterClass

Online MasterClass | 17 & 18 November, 2021

It is common in our globalized world that, according to their specific and particular strengths and interests more than one pharmaceutical is involved in the marketing of a pharmaceutical product, even in the same geographical area or country. It is crucial and tightly required by the Regulatory Authorities that the safety information arising at any point is adequately captured, distributed and adequately and timely reported. The risk benefit ratio should be maintained at all times and for this reason agreements between pharmaceutical companies marketing a certain product should include agreements (so called Safety Data Exchange Agreements, SDAE) to ensure the adequate flow of any arising safety concerns. This should also be considered in all outsourced activities of a pharmaceutical company that may lead to any capture of safety information related to the products of which the company is the Marketing Authorization Holder (MAH)

Advanced Enterprise Risk Management MasterClass

Advanced Enterprise Risk Management MasterClass

Online MasterClass | 29 & 30 November, 2021

• In this time of global uncertainty how do you steer a course through these difficult waters?

• The answer is to anticipate, manage and then deal with the risks at an enterprise level.

• Most organisations have now realised that much more is needed and have developed an Enterprise Risk management (ERM) approach.

• Advanced ERM goes one step further. Risks are evaluated based on business materiality

• New understandings of risk emerge, and efficient controls can be implemented to tackle what really matters to the business. And drive competitive advantage

• In short the focus becomes strategic risk management

Virtual Team Building

Virtual Team Building

A customized course for you

As the World of work is changing rapidly, online team building is becoming more and more popular. These games are great opportunities to engage your remote teams and to build community. Are you in charge of managing a team of remote workers? If so, these virtual team building packages are here to help you keep your employees motivated and get them collaborating with one another. This tool is also a great incentive for any holidays, anniversaries, organizational change or even after successfully finishing an important project. Usually, the main aims of such teambuilding are to reconnect your team, strengthen your company culture and motivate your employees. We have created 3 different packages, so you can choose which one fits the best of your team’s needs. Also, we are happy to tailor-make any of the packages below, so you can bring the best out of your virtual team building.

Regulatory and quality requirements for the design and development of Medical Device Software In-house Training

Regulatory and quality requirements for the design and development of Medical Device Software In-house Training

Twenty-five years ago, software did not feature significantly in medical device legislation. Thirteen years ago it was added as a serious afterthought. As Europe moves to the new Medical Device Regulations, software is recognised throughout the General Safety and Performance Requirements. It has its own rules in classification, whether it is software as a medical device or software as the driver of a medical device. Software has come to the attention of the regulators as a serious source of risk and benefit. This sequence of seminars aims to help those involved in medical device software to understand intricacies of the regulatory burden and how early adoption of the solutions minimises both the costs and time to market.

Development of generics: From R&D to GMP In-house Training

Development of generics: From R&D to GMP In-house Training

The interface between Development and GMP units is one of the most exciting in the pharmaceutical industry. Mutual understanding of the different regulatory environment and the functional priorities is a key success factor. Conflicts, mostly resulting from different approaches and priorities, can have negative impact on business processes even outside the R&D or GMP areas.
R&D needs flexibility and should not be over-regulated, whereas GMP concentrates on standardization and high throughput. On the other hand, R&D has to create a solid and robust fundament to enable manufacturing and quality control to work according to established and efficient procedures.
The training aims to generate a common understanding of how to best interlink these two areas and create highly efficient processes from product development to routine manufacturing of
generic pharmaceutical products.

Risk-Based Validation of Laboratory Computerised Systems In-house Training

Risk-Based Validation of Laboratory Computerised Systems In-house Training

Analytical instruments and computerised systems operating in regulated laboratories must be fit for intended use. This is achieved by using a combination of analytical instrument qualification (AIQ) and computerised system validation (CSV). In the current regulatory environment instruments and systems must ensure data integrity and therefore technical controls must be enabled to ensure this as well as being included within the scope of a CSV project. Regulations, either current interpretations of existing ones or following the issuance of updated ones, allow for risk-based approaches but many laboratories either do not consider this or are held back by ultra conservative quality assurance departments. This course is intended to take a practical and risk-based approach to integrated AIQ and CSV. Instead of automating the status quo any laboratory process should be mapped and redesigned for electronic working by removing spreadsheets and paper printouts. To achieve this requires the implementation of applications that are technically compliant. To reduce the amount of work in a CSV project we will consider: • Effective interpretation of applicable regulations and guidance • How to leverage supplier development and testing into the project • Understand the key principles ofthe FDAs newComputer SystemsAssurance initiative to CSV. • Effective use of risk assessment to focus testing • Impact of IaaS (Infrastructure as a Service) and SaaS (Software as a Service) on CSV projects for larger laboratory informatics applications such as ELNs, CDS and LIMS. • Effective risk-based change control from operating system patches to application upgrades

Blockchain for Pharmaceuticals In-house Training

Blockchain for Pharmaceuticals In-house Training

With an ever increasing regulatory and compliance burden faced by the Pharmaceutical industry, Blockchain is an ideal candidate to address issued across supply chain, clinical trials and R&D. This is happening already with several firms already exploring and developing solutions. This masterclass looks at the technology, the opportunities it offers, the risks and issues to be considered and provides a series of frameworks to determine if blockchain is a good option, how to establish the technology as part of an organisation strategy and how to create a business case.

Data Transparency in Clinical Trials and Fake News In-house Training

Data Transparency in Clinical Trials and Fake News In-house Training

Over the past decade, implementing disclosure and data transparency policies and procedures in clinical trials has become an essential requirement for anyone working in this area. Most of the major pharmaceutical companies have already established transparency policies, spontaneously giving the possibility to access the data collected during their clinical trials to anyone who requests it; at the same time, regulatory agencies such as European Regulatory Agency Policy (EMA), FDA, and the International Committee of Medical Journal The editors (ICMJE) have made the effective management and publication of data collected in clinical trials mandatory.

The management of confidential company data and patient personal data by the study sponsor must therefore be redefined; these requests will translate into an additional workload for those working in the world of medical research, which must however be turned into a new opportunity of adding value to scientific communication. This workshop aims to provide practical tools to manage new requests proactively and effectively in terms of data transparency in clinical trials, producing benefits that go beyond compliance with the rules.

Leadership in Safety In-house Training

Leadership in Safety In-house Training

The Leadership in Safety In-house Training is based upon our multi-award winning Leadership programme, reconfigured to meet the needs of business as a consequence of the Global Coronavirus Pandemic. The virtual workshop takes the lessons and tools shared within our ‘classical’ classroom workshop environment and reinterprets them into an innovative and highly engaging online experience in which guests are able to critically consider the issues that support the emergence of a robust safety culture and the actions that safety leaders can take to support this. It is important for guests to understand that this is NOT a typical videoconference! Despite the fact that guests attend from dispersed locations, this is a workshop and, in the spirit of any workshop, attendees are required to ‘roll up their sleeves (virtually!)’ and get involved in discussions, syndicate activities, role plays etc. By taking the time to listen, to learn and to share you will increase your ability to be a positive influence on the culture of safety that you aspire to. Are you ready to commit to making a positive change?

Fixed Income Portfolio Management In-house Training

Fixed Income Portfolio Management In-house Training

For well over a decade interest rates have been trading at ultra low and even negative levels. It would seem likely that at some stage interest rates will rise, resulting in a fall in bond rices. This course considers some of the tactics that could be used to hedge the associated market and credit risk of a fixed income portfolio.

The course first considers how yield curves move and how they are impacted by central bank activity. This analysis highlights 2-3 active strategies that can be used to exploit the likely change in the slope and curvature of the yield curve. The next part of the course considers how the market risk of a portfolio could be hedged using a variety of fixed income derivatives including interest rate swaps, bond futures and short-term eurodollar futures. The course also looks at how portfolio credit risk could be hedged using single name and index default swaps.

Blockchain for Business In-house Training

Blockchain for Business In-house Training

This course covers the theory AND practice of Blockchains /Distributed Ledger Technology. It is based on the trainer’s extensive background as both an educator, consultant and advisor to numerous blockchain initiatives. The online course has been developed for business executives, leaders and managers. It provides far more than just an understanding of the technology. It provides an in-depth appreciation of the opportunities, risks and strategic approaches that organisations need about Blockchain in order to be fully informed.

The training describes the core components of a blockchain implementation in business, rather than technical, language. It covers the five blockchain mega cases into which all blockchain projects are aligned with. It provides a framework to assess opportunities of revenue generation, cost reduction and risk management. An effective methodology to incorporate blockchain into an organisation strategy is based on several years of successful project and process implementation.

Advanced Risk Based Pricing In-house Training

Advanced Risk Based Pricing In-house Training

In current environment bank profitability is under heavy pressure, especially in Europe. Negative interest rates, flat interest curve, heavy investment needed for digitalization, competition from Fintechs... this is leading bank profitability to historically low levels, and valuations are also suffering since several years.

In this context, ensuring adequate pricing of products is a key challenge to be able to:

• Sustain profitability at an adequate level

• Attract most profitable clients through tailored offer

• Avoid race to nominal profit growth at the expense of long term profitability

Developing an adequate Risk Based Pricing practice can be a key advantage. It is a challenge given it lies at the intersection of several skills, namely commercial, financial and risk expertise’s. Pricing a credit goes far beyond comparing a credit spread to the capital consumed, and this course is designed to dig deeper into this hot topic.

Learning & Development to attract and retain talent In-house Training

Learning & Development to attract and retain talent In-house Training

Do you face challenges to attract or retain talent? An effective L&D strategy will attract and ensure an engaged workforce. An engaged workforce not only goes the extra mile or recommends others to join your company, they are also constantly improving their competencies.

If L&D Management can help you overcome this staffing challenge, how does a 21st century L&D Management look like today?

Covid-19 has recently shaked us and put us in motion. The learning landscape is evolving: more and more companies are embracing online learning. Hybrid learning programmes and virtual classrooms are being organised everywhere. Flip learning is knocking at the door as well. The lessons learned from the “voice of the customer”, the war of talent and society changes force us to thoroughly question the traditional learning.

But how do you get started? Or how do you reinvent it to stay competitive? And what are the key success factors of a performant L&D Management in this new era?

Advanced Forecasting In-house Training

Advanced Forecasting In-house Training

2020 was a stark reminder of just how unpredictable the world is. As events unfolded and policy makers responded it was necessary for banks and other economic agents to continuously update their outlook on how the economy would respond. Markets initially lurched downwards, stocks, commodities and interest rates but then started to look through the immediate impact of the crisis to a recovering economy benefiting from vaccines and the monetary and fiscal tools deployed by policy makers. Many would argue that the markets have been wildly optimistic about recovery, others would disagree. What is clear is that forecasting is much more difficult, and yet far more important, than we might like. The aim of this course is to provide participants with an overview of approaches to forecasting ranging from the classical linearforecasting methods to non-linear approaches, predicting extreme events and the types of techniques used by traders. While the aim is to present a range of techniques, the course is also frank about their weaknesses and great emphasis is placed on making use of all available techniques together with incorporation of expert judgement. During the presentation the trainer will develop models using a range of tools to demonstrate techniques. Participants will have opportunities to explore the models further.

A Stakeholder Engagement Approach to Clinical Trials In-house Training

A Stakeholder Engagement Approach to Clinical Trials In-house Training

About 90% of project management training is about tools and techniques, however most of the job is dealing with the various stakeholders involved in your projects. This series of three master classes are all linked by the engagement of the stakeholders in your projects. Day 1 looks a risk analysis and alongside the traditional view we also look at the risks associated with stakeholder behaviour. Day 2 focuses on the measurement of project progress, but goes beyond the constraints of the iron triangle i.e. are we on budget, on time and with the required quality, to consider the human interactions. Day 3 concentrates on stakeholder engagement and making sure that we understand who the key stake holders are and how we can motivate them.

Meeting the In Vitro Medical Devices Regulation In-house Training

Meeting the In Vitro Medical Devices Regulation In-house Training

The In vitro Medical Devices Directive has been the route to CE marking of in vitro medical devices in Europe since 2002. In 2017 the new In Vitro Medical Devices Regulation (IVDR) was published and comes into force in May 2022. From this moment all IVDs must comply with the new IVDR. At the moment around 20% of IVDs require notified body intervention prior to be being placed on the market, under the new regulation this will increase to around 85%. The new regulation has many more requirements than the current directive and whilst most are not going to prove ‘difficult ‘ to implement, there is much to do in the time left available. The aim of this event is to provide all those involved with IVDs a broad overview of the IVDR with practical guidance to navigating the additions and expectations of the law.

Past Clients

Testimonials

The level of professionalism of the trainer. Fine-tuned program without wasting time

Managing Director – European pharma company

Testimonials

Clear and interesting way of presenting issues, good examples and very knowledgeable trainer.

HR Director - Multinational company based in Europe

Testimonials

Excellent trainer, super skilled, funny and extremely dynamic

M&A Professional

Testimonials

This training was interesting and I would love to attend more trainings like this.

HR Professional

Testimonials

All lectures of the trainer was exactly what I was looking for and it was directly related to my experties and area that I am working. On top of that he prepared all lectures in a very practical way and also took his time to asnwers to the questions and he made sure that we got the asnwer. The organization of this class was also very good.

Pharmaceutical professional

Testimonials

Comprehensive overview with very knowledgeable and experienced trainers. The break-out sessions were great as they made the course more interactive and allowed us to apply the concepts in practice.

Banking professional from Europe

About GLC EUROPE

Global Leading Conferences is specialized in designing, creating and executing impactful, and pragmatic Conferences, Masterclasses and in-house training.

We take pride in empowering thousands of professionals around the world to learn, network, make connections, and do business with thought leaders and visionaries across multiple industries.

GLC actively collaborates with professionals in major sectors, such as Finance, Pharmaceutical, Human Resources, Health & Safety and Energy to understand the challenges and issues that each industry endures, to be able to construct exclusive and top-tier learning and networking platforms.

Specialized in planning, designing, and organizing interactive, impactful, and pragmatic B2B events, GLC actively collaborates with professionals in major sectors, such as Finance, Pharmaceutical, Human Resources, Health & Safety, and Energy to understand the challenges and issues that each industry endures.

10
years

of constructing industry focused events where business meets intelligence

299
events

where we have been learning to provide a unique experience for our customers

3410
speakers

from top-notch industry establishments proven to make a difference

17761
clients

thereof 96% would attend a GLC event again and would recommend GLC

The MANAGEMENT

GHAZAL ZOHREHNEJAD

Managing Director / Co-founder

LÁSZLÓ ÁRVAI

Managing Director / Co-founder

KRISZTIÁN ÖTVÖS

Managing Director / Co-founder