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May 17
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08:00 - 09:00 60 mins
European Regulatory Affairs Forum
Registration
09:00 - 09:30 30 mins
European Regulatory Affairs Forum
KEYNOTE: Feedback from the European Commission on the regulatory landscape for pharmaceuticals
  • Aude L'hirondel - Legal Officer, DG SANTE Unit B5 - Medicines: policy, authorisation and monitoring, European Commission
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  • Current priorities and challenges
09:30 - 10:00 30 mins
European Regulatory Affairs Forum
KEYNOTE: Feedback from the EMA: Framing emerging techonologies-nanomedicines
  • Ruben Pita - Legal Department, EMA
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  • The quest for a definition - why it is important:
    • Applying new active substance status
    • Specific requirements in Directive 2001/83/EC: quality/safety/efficacy, Environmental Risk Assessment, Pharmacovigilance
    • Abridged applications
    • Scoping under the centralised procedure
  • Medicinal products versus Medical devices
10:00 - 10:30 30 mins
European Regulatory Affairs Forum
Morning Coffee
10:40 - 11:20 40 mins
European Regulatory Affairs Forum
Exploring current political changes in the EU and assessing their impact on the pharmaceutical regulatory landscape
  • Adela Williams - Partner, Arnold and Porter
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  • Examining how to minimise risk during current political changes
  • Assessing the impact of digital health on the regulatory landscape
  •  Understanding what Brexit might mean for how industry should work with the UK in the future
11:15 - 11:55 40 mins
European Regulatory Affairs Forum
Managing regulatory oversight at a global level
  • Horst Kastrup - Senior Regulatory Advisor, Meda Pharma
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  • Managing and maintaining marketing authorisations in various jurisdictions
  • Reviewing the uncertainties from approval and risk management
  • ICH management- understanding common mistakes and gaining clarity on best practices
11:50 - 12:20 30 mins
European Regulatory Affairs Forum
Examining how regulatory harmonisation can be improved in Europe
  • Daniel O’Connor - Expert Medical Assessor & UK representative on COMP, MHRA
  • Doris Stenver - Chief Medical Officer and member, Pharmacovigilance Risk Assessment Committee (PRAC), Danish Medicines Agency
more
12:10 - 13:40 90 mins
Main agenda
Networking Lunch
13:30 - 13:50 20 mins
European Regulatory Affairs Forum
Flash Presentation- Industry Perspective: Orphan medicinal products – current challenges and opportunities and outlook for the future
  • Diego Ardigo - Project Lead, Special Care and Rare Diseases Unit, Chiesi
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  • Evolution of the development and reimbursement framework for orphan medicinal products: nightmare or Eldorado?
  • Overcoming the challenges of obtaining sufficient evidence in a small population to quantify benefit-risk for regulatory authorities and demonstrate value-for-money to payers.
  • Future outlook: the impact of one-off treatments based on advanced therapeutic approaches on R&D and market access for orphan indications.
13:50 - 14:20 30 mins
European Regulatory Affairs Forum
Authority Perspective: Orphan medicinal products – current practice and outlook for the future
  • Daniel O’Connor - Expert Medical Assessor & UK representative on COMP, MHRA
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  • Overview of the EU regulatory framework for orphan medicinal products
  • Regulatory initiatives to support development of medicines in rare diseases
  •  Future outlook and impact of the Commission notice on the application of the orphan regulation
14:20 - 15:00 40 mins
European Regulatory Affairs Forum
10-year anniversary of the EU Paediatric Regulation – lessons learned so far
  • Solange Rohou - Senior Director Regulatory Affairs & Policy, Europe, AstraZeneca
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  • Clarifying the scope of the Regulation
  • Assessing whether Regulation needs amending
  • Industry feedback: What have been the challenges and opportunities?
15:00 - 15:30 30 mins
Main agenda
Afternoon Refreshments
15:30 - 16:10 40 mins
European Regulatory Affairs Forum
New legislative updates for clinical trials and examining the implications for industry
  • Dr Surendra Gokhale - Head, EU/International Clinical Trials Regulatory Management, F. Hofffmann-La Roche Ltd.
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  • Examining the scope of the regulation
  • Exploring major differences between the previous and new legislation and
  • Understanding how to adapt existing and upcoming clinical trials to fit new requirements
  • Challenges and opportunities for Industry    
16:10 - 16:50 40 mins
European Regulatory Affairs Forum
EU Pharmacovigilance - Update on the activities in the PRAC
  • Doris Stenver - Chief Medical Officer and member, Pharmacovigilance Risk Assessment Committee (PRAC), Danish Medicines Agency
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  • EU Pharmacovigilance legislation and guidance status
  • The signal management procedure and new signals assessed by the PRAC
  • Experience with the referral procedures
  • Information to patients
  • Impact assessment of legislative framework