European Regulatory Affairs Forum

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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