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*