Unfortunately, this Live Online Training cannot take place on this date. As soon as a new date is fixed, you will find the information on this page.
Sprecher
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
Zielsetzung
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.
Hintergrund
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.
Zielgruppe
Technical Requirements
For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and eas
Programm
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
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
Frank Sielaff, c/o Local Council Darmstadt
- Relevant GMP Guidelines
- What is in focus of a GMP inspection and what is not?
- GMP challenges
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
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
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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