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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
Francisco Baptista, Regulatory Affairs Manager - Team Lead, Arriello
Francisco is the current Chair of TOPRA’s CMC SPIN and works as a Regulatory Affairs Manager – Team Lead at Arriello. He holds a Master’s Degree in Pharmaceutical Sciences from the University of Coimbra, Portugal, and is a certified RSCi Scientist by the Science Council. With over eight years of experience in pharmaceutical regulatory affairs and consulting, he has extensive expertise in managing the entire regulatory process—from early development and strategic planning to marketing authorization and lifecycle activities.
Francisco has led a broad range of regulatory activities, including Early Development activities (such as Scientific Advices), Marketing Authorization Applications (MAAs), variations, renewals, and lifecycle management across more than 30 markets worldwide (EU, South America, Africa, Asia, and Oceania).
From the beginning of his career, he has been deeply involved in CMC writing, from pharmaceutical development and initial dossier preparation to managing variation submissions, fostering his passion for dossier quality. His expertise extends to the coordination and strategic management of technology transfers, where he played a key role in ensuring quality compliance and regulatory alignment for a wide range of products and pharmaceutical forms.
Lisa Hinchliffe
Based in the UK, Lisa is a co-Chair of TOPRA’s CMC SPIN and has around 25 years' experience working in Regulatory CMC roles across Clinical Trials, Licensing and Post-Licensing projects for a variety of leading global pharmaceutical organisations as well as working with a variety of smaller companies on large and small molecule projects. Lisa has run her own limited company consultancy specialising in the CMC aspects of Regulatory submissions for about 15 years.
Lisa is a Chartered Chemist and active Member of the Royal Society of Chemistry and current Chair of the Joint Pharmaceutical Analysis Group (JPAG) & committee member for Solutions in Science (SinS) 2025. She holds a BSc Hons in Chemical and Pharmaceutical Sciences from the University of Sunderland and a PhD in pharmaceutical chemistry from the University of Derby.
She has continuously been involved in both CMC writing and strategy working closely with other regulatory, technical, quality and manufacturing colleagues with a passion for consistency and high dossier quality. Since her early days in the field, Lisa has been involved in training and mentoring, using over 20 years of her volunteer time with TOPRA and the RSC, very effectively, to showcase the expertise and abilities of outstanding contemporaries in the CMC field and particularly in the last five years to raise the profile of Regulatory CMC within the industry.
Pricing
TOPRA Member: Free
Non Member: £45