Informa
기조 세션

Florian Schmidt

기조 강연:약사 규제 상황에 관한 유럽위원회의 새로운 견해

European Commission, Belgium

5월 22일
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08:00 - 08:50

Registration

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Showing of Streams
10:40 - 11:10

Networking Break

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Showing of Streams
12:40 - 14:10

Networking Lunch

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Showing of Streams
15:50 - 16:20

Networking Break

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Showing of Streams
17:20 - 17:25
Chairperson's Closing Remarks

Chairperson's Closing Remarks

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17:25 - 18:15

Close of Regulatory Frameworks Day

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Showing of Streams
20:15 - 21:15

Networking Dinner

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08:00 - 08:50 50 mins
Registration
08:50 - 09:00 10 mins
Regulatory Frameworks
Introduction from Chairperson
09:00 - 09:40 40 mins
Info
Regulatory Frameworks
KEYNOTE PRESENTATION: EU Commission Update on the Regulatory Landscape for Pharmaceuticals
  • Florian Schmidt - Legal Advisor, DG SANTE, European Commission, Belgium
  • Update on the review into pharmaceutical incentives and rewards: views and timetable
  • Key areas for analysis and the potential implications for availability and accessibility
  • Areas of focus for potential legislative revision
09:40 - 10:40 60 mins
Info
Regulatory Frameworks
INTERACTIVE DISCUSSION FORUM The Evolving European Regulatory Landscape Post Brexit
  • Grant Castle - Partner, Covington & Burling LLP, UK
  • Victoria Kitcatt - Vice President and Assistant General Counsel, Pfizer, UK
  • Florian Schmidt - Legal Advisor, DG SANTE, European Commission, Belgium
  • Jonathan Mogford - Director of Policy, MHRA, UK
  • Unveiling MHRA's plans and post Brexit guidelines

Similarities and divergence from EU regulations

Practical insight into gaining marketing authorisation in the UK

  • Plans and priorities for 2019 and beyond

Practical implications of Brexit on EU pharmaceutical regulations: how has the approach evolved?

Update on plans, priorities and progress: practical focus on inspections, evaluations and certification

  • Impact on the pharmaceutical industry: what can we expect in the coming year?
10:40 - 11:10 30 mins
Networking Break
11:10 - 11:40 30 mins
Info
Regulatory Frameworks
Orphan Market Exclusivity: Regulatory Framework, Challenges and Opportunities
  • Hilary Jones - Senior Director, Cell Therapy Legal & Business Conduct, Gilead Sciences EU, UK
  • Update on regulations, trends and case law
  • Insight into the EU Orphan Medicines Regulation review: consultation, analysis and industry view
  • Market access challenges for Orphans drugs

11:40 - 12:20 40 mins
Info
Regulatory Frameworks
DUAL DIALOGUE Challenges and Opportunities for Regulatory Data Exclusivity
  • Marie Manley - Partner, Sidley Austin LLP, UK
  • Helen Middleton - Principal Legal Adviser, Mundipharma International, UK
  • Scope and practical application of regulatory exclusivity
  • Practical implications of the Astellas case: impact on industry market strategies
  • Challenging the notion of global marketing authorisation: pitfalls and opportunities for different routes to approval 
  • Examining the complexities of asserting rights to data exclusivity
12:20 - 12:40 20 mins
Info
Regulatory Frameworks
FLASH PRESENTATION Obligations of the Nagoya Protocol for R&D on Genetic Resources
  • Bart Van Vooren - Senior Associate, Covington & Burling LLP, Belgium
  • Understanding international and EU rules implementing the Nagoya Protocol to the Convention on Biological Diversity
  • Ensuring compliance: arrangements to ensure legal utilisation of genetic resources in global R&D activities
12:40 - 14:10 90 mins
Networking Lunch
14:10 - 15:10 60 mins
Info
Regulatory Frameworks
DUAL DIALOGUE: Regulations for eHealth, Mobile Apps and Artificial Intelligence
  • Marc Martens - Partner, Co-Head of the International Life Sciences and Healthcare Group, Bird & Bird LLP, Belgium
  • Overview of the regulations and classification for digital offerings: AI, mobile apps, software, websites
  • What does the rise of AI mean for legal assessments and considerations?
  • Demystifying responsibility: practical scenarios which thing go wrong and who is responsible
  • Common pitfalls and challenges for compliance
15:10 - 15:50 40 mins
Info
Regulatory Frameworks
DUAL DIALOGUE Pharmaceutical Marketing, Advertising and Promotional Activity
  • Marc Christian Bauer - Vice President - Legal, Compliance and Corporate Affairs, Tesaro, Switzerland
  • Livia Zamfiropol - Partner, DLA Piper LLP
  • Latest developments, and case law on pharmaceutical promotional activity
  • Understanding liability when lines are crossed
  • The rise and challenges of social media, mobile apps and e-health tools
15:50 - 16:20 30 mins
Networking Break
17:00 - 17:20 20 mins
Info
Regulatory Frameworks
INTERACTIVE DISCUSSION FORUM Market Access: The Convergence of Regulation, Pricing and Reimbursement
  • Peter L'Ecluse - Partner, Van Bael & Bellis LLP, Belgium
  • Hanneke Later-Nijland - Attorney-at-Law | Counsel, Axon Lawyers LLP, The Netherlands
  • Arianna Greco - Vice President, Head of International Legal, Alnylam Pharmaceuticals, Switzerland
  • Latest developments: examining levers utilised by healthcare authorities in price negotiations
  • The rise of compounding pharmaceuticals: challenges to authorised products and exclusivity in the Netherlands?
  • Challenges for reimbursement for ATMPs and orphan medical products
  • How and to what extent are countries working together to create structures and forms of co-operation to prepare for market access negotiations?
17:20 - 17:25 5 mins
Chairperson's Closing Remarks
17:25 - 18:15 50 mins
Close of Regulatory Frameworks Day
18:15 - 18:30 15 mins
Demystifying the MDR and IVDR
Registration
18:30 - 20:15 105 mins
Info
Demystifying the MDR and IVDR
Demystifying the MDR and IVDR
  • Erik Vollebregt - Partner, Axon Lawyers, The Netherlands

New Regulations and Changes Relevant to Pharmaceutical Companies

  • MDR and IVDR readiness - when what why how?
  • Legal ramifications and practical implications of changes in scope of medical devices / IVD regulation and relation to Directive 2001/83
  • Overview of the key areas likely to need upgrading to comply with the MDR/IVDR, such as companion diagnostics and combination products
  • Practical guidance on gaining CE Marking under the MDR/IVDR


Specifics for Combination Products, Borderline Products and Companion Diagnostics

  • MDR consequences for drug - device and device - drug combination products
  • IVDR consequences for companion diagnostics
  • Common pitfalls and challenges for software and digital tools


20:15 - 21:15 60 mins
Networking Dinner

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