
AGENDA 2023 – IN PROGRESS
The agenda of the European Regulatory Affairs Forum 2022.
MAY 12, 2022
9:00 (UTC+1) |
Welcome and Introduction Chairperson Pharma Education Center |
9:10 | Opening Remarks Raffaella Pandini | RA Operational Manager | Pharma D&S |
SESSION I – THE REGULATORY FRAMEWORK OF INNOVATIVE THERAPIES | |
9:20 | Advanced Therapies: Innovative Products, Innovative Pathways to Approval Andreas Vogel | Senior Director, Head of International Regulatory Affairs | Apellis Pharmaceuticals |
9:45 | Regulatory CMC strategies and challenges for Biologicals Neha Parashar | Principal Scientist / Associate Director – CMC Regulatory | argenx |
10:10 | Q&A session |
SESSION II – DRUG COMBINATION PRODUCTS | |
10:35 | Impact of EU Medical Device Regulation on Drug Device Combination Products Tina Amini | Medical Device & Combination Products Division Director | NDA Group |
11:00 | Coffee Break |
11:20 | Device Submission Content in eCTD Format for “Combination Products” in the EU Javad Jabbari | Associate Director Regulatory Affairs Device | Ascendis Pharma |
11:55 | Q&A session |
SESSION III – EXTRA EU MARKETS: REGULATORY ASPECTS AND CHALLENGES | |
12:15 | Regulatory Affairs challenges and opportunities in the META region Joëlle Issa Blok | Director Regulatory Affairs, Quality & Pharmacovigilance, META | ACINO |
12:40 | International Regulatory Cooperation: A Latin America overview Mariana De Angelo Silva Alegre | Associate Director Regulatory Affairs – LatAm | Johnson & Johnson |
1:05 | Lunch Break |
2:00 | Brazilian and Latam Regulatory Environment – Key Aspects, Differences, Evolution Simão Correa da Silva | Head of Regulatory Affairs Latam | Dr. Reddy’s Laboratories |
2.30 | Q&A session |
SESSION IV – DIGITAL TRANSFORMATION IN RA | |
2:55 | Overcoming the “language barrier” – How IDMP requirements force digital transformation Gunnar Häcker | Business Project Manager Regulatory Affairs | Boehringer Ingelheim |
3:20 | Structured Regulatory data submissions Ankit Geete | Associate Director – Global Regulatory Affairs | Merck Group |
3:45 | The first step towards package leaflet digitalization Giovanna Cappellari | Regulatory Affairs Manager | Roche |
4:05 | Q&A Session |
SESSION V – THE CLINICAL TRIALS REGULATION | |
4:25 | CTR and submission activities after the CTIS go live Speaker TBC |
4:45 | Q&A Session |
5:00 | Closing Remarks Raffaella Pandini | Pharma D&S |
MAY 13, 2022
9:00 (UTC+1) |
Welcome and Introduction Raffaella Pandini, RA Operational Manager, Pharma D&S |
SESSION VI – REGULATORY FRAMEWORK FOR BIOLOGICAL PRODUCTS | |
9:10 | Biologicals: regulatory aspects and experiences with Regulatory Authorities Stefania Palladino | Regulatory Affairs Manager | Opocrin S.p.A. – LDO (Laboratori Derivati Organici) |
9:40 | Q&A Session |
SESSION VII – PRICING AND REIMBURSEMENT OF MEDICINAL PRODUCTS IN ITALY | |
9:55 | Introduction to the session Ilaria Brocchi | Senior Project Manager & Team Leader Regulatory Affairs | Pharma D&S |
10:00 | Price and reimbursement dossier: a focus after one year of experience Raffaella Pandini | Pharma D&S |
10:30 | Q&A Session |
10:45 | Coffee Break |
SESSION VIII – RISK MANAGEMENT PLAN OBLIGATIONS | |
11:10 | Introduction to the session Raffaella Pandini | Pharma D&S |
11:15 | Educational materials – the italian process for approval Ilaria Brocchi | Pharma D&S |
11.45 | Q&A Session |
SESSION IX – NATIONAL MONITORING REGISTERS OF MEDICINAL PRODUCTS | |
12:00 | Introduction to the session Raffaella Pandini | Pharma D&S |
12:40 | AIFA monitoring registries: Post-marketing data collection and evidence evaluation Pier Paolo Olimpieri | Data analysis coordinator – Monitoring Registries Office | AIFA |
12:30 | AIFA registers as a real world evidence tool: the Roche experience and possible perspectives Nicola Panzeri| Head of Regulatory Affairs | Roche |
12:55 | Q&A Session |
1.15 | Closing Remarks and End of the Forum Raffaella Pandini | Pharma D&S Chairperson Pharma Education Center |
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