Genetically Modified Vaccines - Additional Guidance Needed? - Live Online Use of regulations and interaction with authorities

Genetically Modified Vaccines - Additional Guidance Needed? - Live Online

Course No 19459

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Petra Falb, AGES
Pierre A. Morgon, PharmD, LL.M, MRGN Advisors
Dr Bernd Renger, Bernd Renger Consulting
Dr Frank Sielaff, GMP Inspector
Dr Lyudmil Tserovski, BioNTech
Peter Walters, CRB


Genetic modification technologies were widely used for vaccine development during the COVID-19 pandemic, for other vaccines and for veterinary vaccines. Several products have been approved around the world. In the EU, products that protect against infection with an infectious organism are by definition vaccines. And as such, vaccines are excluded from the ATMP guidelines - even if technologically they use techniques known from gene therapy. Particularly in the case of approaches that were not previously approved as medicines, such as mRNA lipid nanoparticles, some companies face a regulatory environment that does not seem fully transparent to them and in which there appears to be a lack of appropriate guidance.

This Live Online Training discusses the regulatory landscape for such genetically modified vaccines, especially when these gene therapy technologies overlap with traditional vaccine areas and vaccine regulations. This workshop will highlight the current regulatory situation and use case studies from manufacturers to show the challenges and hurdles in development, manufacturing and approval. It also seeks to identify the extent to which further guidance is needed beyond the existing guideline documents. One question could also be how this is viewed internationally when the requirements or classifications of the products differ, e.g. in Europe and in the USA.


The quality of a medicinal product, and thus also that of a vaccine, is of crucial importance for its safety and efficacy and thus for its suitability for the patient. Given the growing recognition of the increasingly important role of biological medicines in healthcare worldwide, competent authorities have already published a whole range of guidelines and helpful documents. Products such as ATMPs, but also genetically modified vaccines, have the potential to transform patient and healthcare delivery worldwide.

However, the development, characterisation and manufacture of these innovative medicines is particularly challenging due to their high complexity and emerging technologies. In the course of development, transfer and manufacture, new questions often arise that also need to be clarified from the regulatory side. Are further specifications from the authorities necessary for this? Where are there still gaps? What experience have manufacturers gained so far in the approval process? Especially with a view to worldwide use.

Target Group

This Live Online Training is aimed at all staff and regulatory representatives involved in the development, manufacture, quality assurance and authorisation of vaccines and/or ATMP in general and gene therapy medicines in particular.

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Moderation, Welcome and Introduction
Dr Sabine Hauck, Leukocare, Chair of the ECA ATMP Interest Group and Axel H. Schroeder, Concept Heidelberg, Administration Manager of the ECA ATMP Interest Group

Current Regulatory Framework for Genetically Modified Vaccines
Petra Falb, AGES
  • Relevant Guidelines
  • Licensing regulatory background
Case Study – mRNA Product – Regulatory Requirements and Hurdles
Lyudmil Tserovski, BioNTech
  • Basic mechanism of action of mRNA based vaccines and anti-cancer ATMPs
  • GMP aspects of mRNA-based medicinal products (manufacturing and control)
  • Regulatory aspects depending on the type of medicinal product (ATMP or Vaccine)
  • Challenges concerning the supply chain and the QP certification
Regulatory GMP Landscape
Frank Sielaff, c/o Local Council Darmstadt
  • Relevant GMP Guidelines
  • What is in focus of a GMP inspection and what is not?
  • GMP challenges
Possible (Quality) Pitfalls on the Way to Marketing Authorisation
Bernd Renger, former Chair of the European QP Association
  • What quality systems and GMP compliance level to  expect
  • API and formulated API (LNP)
  • Novel excipients
    • Functional and structural lipids
    • Polymerosomes
  • Oligodeoxynucleotide adjuvants
Vaccines and Gene Therapy - Same but Different
Peter Walters, CRB
  • Way of manufacturing vs. route of administration vs. legally classification
  • The complication that vaccine technologies have evolved, but are still regulated under different conditions
  • How the future of the industry will possibly need to be updated in the wake of gene therapy innovation
Business and  Healthcare Policy Perspectives
Pierre A. Morgon, PharmD, MBA, LL.M
  • From acceptability across the entire landscape of stakeholders to the contribution to availability and accessibility

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