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Regulatory Quality/CMC
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Advanced Manufacturing
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Platform Technologies
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EMA Quality Innovation Group
Benefits for participants
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Learn about the value of and industry interest in platform technologies
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Stay updated with current EFPIA cross-industry activities
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Practical Strategies for engaging with the EMA Quality Innovation Group
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Expert Guidance in communicating about platforms and prior knowledge with regulators
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Q&A Sessions: Engage in interactive Q&A sessions, allowing you to receive tailored advice for your specific questions
Description
In this webinar, Dr Vanhooren will specifically cover:
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The development of Pfizer’s new Continuous Direct Compression (CDC) platform technology
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Manufacturing and other platforms in focus at EFPIA (European Federation of Pharmaceutical Industries and Associations)
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The November 2024 EMA Quality Innovation Group “Listen and Learn Focus Group” meeting on Platform Technologies
The main webinar presentation will run for approximately 25 minutes, which will then be followed by a Q&A session. Please feel free to send questions or request for topics to discuss when you register.
Presenter
Dr Meike Vanhooren, Senior Director Pfizer
Meike earned her Ph.D. in organic synthesis of carbohydrate structures at the University of Hamburg, Germany and has more than 25 years of experience in the pharmaceutical industry covering regulatory, manufacturing and quality areas and she was TOPRA CMC SPIN Chair between 2016-2019. She currently represents Pfizer in the European Federation of Pharmaceutical Industries and Associations (EFPIA) Manufacturing Quality Expert Group (MQEG).
She is based in Germany and has global responsibility for Chemistry, Manufacturing and Controls (CMC). Her portfolio of skills includes the complete product life cycle, from IND/IMPDs for First-in-Human clinical studies, NDA/MAA applications through to post-approval lifecycle maintenance.?
With her international team Meike is accountable for:
• effectively engaging regulatory authorities and ensuring legal obligations to maintain conformance and compliance are met;
• developing regulatory strategies globally and providing regulatory clarity for scientists in research & development and manufacturing divisions.
Meike also has extensive experience in drug development of accelerated programs as well as programs with novel technologies such as continuous manufacturing processes including successful MAA/NDA approvals. She has been responsible for executing CMC strategies for manufacturing site changes and successfully completed more than 900 transfers impacting more than 22,000 licenses globally and is engaged in discussions on ICH Q12 Lifecycle Management and ICH Q13 Continuous Manufacturing.
Moderator
Janine Jamieson, European Editor, International Pharmaceutical Quality
Janine is European Editor at International Pharmaceutical Quality (IPQ) Publications, writing about the regulatory dialogue at biopharma conferences on quality/CMC issues, with special interests in drug-device combination products, innovation in manufacturing, and global regulatory systems strengthening. Janine was previously a pharmaceutical assessor in the Medicines Licensing Division of the UK MHRA from 1997 until June 2016. She now lives in Sweden.
Janine has been an enthusiastic contributor to TOPRA over many years, from involvement in special interest networks to training and chairing Symposium sessions. She was on the TOPRA Board of Directors from 2020-2021.
Pricing
TOPRA Member: Free
Non Member: £45