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 |
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