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

Contact

(+39) 055 72 27 007
(+39) 055 72 24 076
(+39) 055 72 24 179

Via Dei Pratoni, 16 – 50018 Scandicci (FI)
Tel. (+39) 055 0465181
E-mail: info@pharmaeducationcenter.it