Program: 15 October

08:30 Registration
09:15 Welcome
PEC representative
09:20 Opening remarks by the Chairpersons of EuRA Forum
Raffaella Pandini – Regulatory Affairs Operational Manager – Pharma D&S
Marcella Marcellini – Regulatory Affairs Project Manager – Pharma D&S
SESSION I – THE EUROPEAN REGULATORY AFFAIRS LANDSCAPE: CHANGES, IMPACTS OF NEW REGULATIONS AND REGULATORY TRENDS OF NEW THERAPEUTIC PRODUCTS
09:30 EU Clinical Trials Regulation; An update on the current status and some thoughts on its implementation
• The upcoming EU Clinical Trial Regulation No 536 (EC) 2014 implementation: what does it mean?
• Perspective from a mid-sized pharma company
• A summary of the main changes versus the current situation
• Current status of implementation
• How will implementation of this regulation impact our processes
• Challenges and opportunities
Sol Yates – Global Regulatory Affairs Manager at Grünenthal – Germany
10:00 Q&A
10:10 How Orphan drug designation and scientific advice procedures fit in the overall clinical development of a medicinal product?
The presentation will describe the objectives, the criteria and the procedure to obtain ODD and SA in EU for an orphan products. In addition, advice will be provided on important considerations to take into account when preparing for such procedures.
• Objectives and procedures to obtain ODD in EU
• Objectives and procedures to obtain SA in EU
• Important considerations to take into account:
– Importance of global development and consultation with other regulatory authorities
– Importance of additional stakeholders engagement in parallel with regulators (Physicians, Patients advocacy groups, payers/HTA bodies)
• Opportunities and challenges of such approaches
Camille Metais, Global Program Team Lead at Alexion Pharma GmbH
10:40 Q&A
10:50 Networking & Coffee Break
11:20 Biologicals and Biosimilars: a regulatory perspective
• What makes biological molecules different to small molecules?
• What is a biosimilar
• EMA/FDA attitude towards biosimilars, safety/efficacy/quality, clinical and non-clinical evaluation, PK/PD study, immunogenicity, extrapolation, PV, prescription information
• Regulatory procedures for approval in EU and US
Paola Tocchetti, Global Regulatory EU – Italfarmaco
11:50 Q&A
SESSION II – IDMP & REGULATORY INFORMATION MANAGEMENT
12:00 Regulatory Information Management
Regulatory Information Management (RIM), handling of structured data and new ways of information exchange with external stakeholders is becoming more and more important for regulatory affairs (RA) departments. This session will accompany you on the digital transformation journey by discussing RIM in light of the maturity of a RA department, potential performance metrics and guide you into a discussion on the need for improved ways of informing empowered patients about product information with modern technology.
Rudiger Faust, Regulatory Strategy & Intelligence Lead, Innovation Unit Devices & Technologies – Grünenthal Group
12:40 Q&A
12:50 Lunch & Networking Time
14:00 Key considerations for IDMP enabled regulatory transformation platform
Pratyusha Pallav, ArisGlobal
14:20 Q&A
SESSION III – EXTRA EU REGISTRATION: CHALLENGES AND STRATEGIES
14:30 Developing a global regulatory strategy in times of regulatory uncertainty and change
• Assessing commonalities and differences between specific local requirements across regions
• Outlining the challenges facing regulatory professionals in post approval world and ensuring supply continuity
• Overcoming the challenges of variety and variability of regulations and timelines across the globe
Alessandra Leone, Global CMC Senior Manager – PTx at Pfizer
15:10 Q&A
15:30 ROUND TABLE
THE EVOLUTION OF EUROPEAN REGULATORY AFFAIRS LANDSCAPE: CURRENT AND FUTURE CHALLENGES
How the RA environment is changing due to the political changes, to the technological and scientific progress, to the more patient-centric view – which are the future challenges of EU RA for a better support in the innovation and life cycle of medicines?
Moderators: Marcella Marcellini – Raffaella Pandini, Pharma D&S
Participants:
Patrizia Ciavatta – Novartis
Rudiger Faust – Grunenthal
Alessandra Leone – Pfizer
Camille Metais – Alexion
Pratyusha Pallav – ArisGlobal
Paola Tocchetti – Italfarmaco
Sol Yates – Grunenthal
16:30 Conclusion & Networking Time

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