European Regulatory Affairs Forum 2021 - agenda

MAY 12, 2021

09:00	Introduction Chairperson: Raffaella Pandini,* RA Operational Manager, Pharma D&S* Co-chairperson: Ilaria Brocchi,* RA Senior Project Manager, Pharma D&S*
SESSION I – THE REGULATORY FRAME OF INNOVATIVE THERAPIES
09:15	New therapeutic scenarios in the evolution of pharmaceuticals Raffaele Cerbini, Executive Medical Director
09:35	Early Access Regulatory Pathways (EMA FDA) for new Therapies Paolo Dametto, Sr. Manager – International Regulatory Science, Moderna
10:00	Rolling review & emergency procedures for COVID 19 vaccines Federica Grotti, Regulatory affairs Head, Pfizer Italy
10:25	Panel discussion / Q&A Moderator: *Raffaele Cerbini* Participants: Patrizia Ciavatta, Angelini Paolo Dametto, Moderna Federica Grotti, Pfizer Italy
11:00	Coffee break
SESSION II – THE REGULATORY LANDSCAPE AFTER BREXIT
11:20	A Globally Attractive UK? Phil Brown, Director, Regulatory & Compliance, Association of British HealthTech Industries
11:50	Q&A Time
SESSION III – EXTRA EU AND EMERGING MARKETS: REGULATORY ASPECTS AND CHALLENGES
12:05	Regulatory Strategies for Inclusion of China into the Global Development of Innovative Drugs Stefano Accorsi, MSc EMBA – Head of Regulatory Affairs “China and International”, Global Regulatory Affairs, Chiesi Farmaceutici
12:30	Eurasian Economic Union: an overview and experience from the first wave of harmonizations Alessandra Leone, Global CMC Senior Manager – PTx, Pfizer
13:00	Lunch
14:00	Panel discussion / Q&A Time Stefano Accorsi, Chiesi Farmaceutici Marcello Colao, Sr. Director, Global Quality Head China Vaccines, GSK Alessandra Leone, Pfizer
SESSION IV – THE PHARMA DIGITALIZATION
14:30	Business impacts caused by the switch from eCTD 3.2 to the next major version eCTD 4.0 Frank Dickert, Senior Business Consultant, EXTEDO
14:50	Q&A Time
15:00	Digital health transformation and innovative technologies in healthcare Roberto Ascione, CEO, Healthware Group
15:25	The evolving global regulatory landscape for digital health software Priya Tiwari, Associate Director Global Regulatory Affairs – Digital Health, Combination Products and Medical Devices, Biogen
15:50	Panel discussion / Q&A TIME
SESSION V – DRUG-DEVICE COMBINATION: An evolving global regulatory scenario
16:10	Comparison MDR-FDA legislation in the registration of combined products Priya Tiwari, Associate Director Global Regulatory Affairs – Digital Health, Combination Products and Medical Devices, Biogen
16:35	Panel discussion
16:50	Final remarks & Closure, Raffaella Pandini, Pharma D&S
17:00	End of the Forum

MAY 13, 2021

09:00	Introduction Chairperson: Raffaella Pandini, RA Operational Manager, Pharma D&S Co-chairperson: Stefano Nepi, Team Leader Project Manager, Pharma D&S
SESSION VI – THE ICH Q12 GUIDELINE: CHALLENGES AND OPPORTUNITIES
09:15	Lifecycle Management of Pharmaceutical Products Global Harmonization of Post-Approval Changes (ICH Q12) Jean Louis Robert, EU topic leader for Life Cycle Management ICH Q12, former chair of CHMP-QWP
09:45	Implementation of ICH Q12 – an Industry Perspective Mihai Bilanin, Director, Global Regulatory CMC, GSK Biopharmaceuticals
10:15	Panel discussion / Q&A Time
SESSION VII – NITROSAMINES ASSESSMENT
10:30	NITROSAMINES: RA points of situation and experience with European HAs Raffaella Pandini, RA Operational Manager, Pharma D&S
10:55	Panel discussion / Q&A Time
11:10	Coffee Break
SESSION VIII – PRICING AND REIMBURSEMENT OF PHARMACEUTICALS IN ITALY
11:30	The new AIFA Prici ng & Reimbursement guideline: overview and differencies with the previous dossier Alessandra Perini, LL.M. (UCL), In-house Counsel, Pharmaceutical Legal Expert
12:00	Panel discussion / Q&A Time
SESSION IX – ELECTRONIC COMMON TECHNICAL DOCUMENT – eCTD
12:15	The electronic Common Technical Dossier (eCTD): experience with ASMF Lisa Milazzo, Regulatory Affairs Consultant, Pharma D&S
12:40	The electronic Common Technical Dossier (eCTD) and important regional differences Hans Rensland, Managing Director, RACON Regulatory Affairs Consulting GmbH
13:05	Panel discussion / Q&A Time
13:20	Closure of the Forum