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Understand Impending Changes for Harmonised Submission and Assessment Requirements

March 6-7, 2018
  • Brussels, Belgium

CBI’s EU Clinical Trial Regulation Summit provides everything you need to know about the new regulatory framework. Learn more about the impending clinical trial regulation and its associated guidelines plus a summary of differences relative to the existing directive. You will benefit from hearing about how submission and evaluation of clinical trial applications is expected to change by 2019 from an unparalleled speaking faculty including:

CONFERENCE CHAIRPERSON Moira Daniels, Vice President, Head of Regulatory Affairs, UCB

Sini Eskola, Director, Regulatory Affairs,
European Federation of Pharmaceutical Industries and Associations (EFPIA)

Greet Musch, General Director, Pre-Marketing Authorisation,
Federal Agency for Medicines and Health Products (FAMHP), Belgium

Christopher Price, Manager, Global Regulatory Affairs – Oncology, Merck KGaA

Marianne Andersson, MSc Pharm,
Lead, Regulatory Processes & Partnerships, AstraZeneca

Matthias Zerm, PhD, Global Clinical Development, Lead Expert,
Clinical Trial Disclosure and R&D Processes, Merz Pharmaceuticals GmbH

Key Attendee Benefits:

  • Gain in-depth insight into the EU Clinical Trial Portal and Database
  • Evaluate the common themes of the EU Clinical Trials Regulation
    (CTR), the EU Medical Devices Regulation (MDR) and the
    EU General Data Protection Regulation (GDPR)
  • Hear How Brexit Could Impact the Implementation of the
    EU Clinical Trial Portal
  • Identify best practices for establishing a successful
    lay summaries process
  • Take a look at Belgium’s national pilot program for
    implementing the EU guidelines

We'll see you there!

EU Clinical Trial Regulation Summit

Understand Impending Changes for Harmonised Submission and Assessment Requirements

CBI’s EU Clinical Trial Regulation Summit provides everything you need to know about the new regulatory framework. Learn more about the impending clinical trial regulation and its associated guidelines plus a summary of differences relative to the existing directive. You will benefit from hearing about how submission and evaluation of clinical trial applications is expected to change by 2019 from an unparalleled speaking faculty including:

CONFERENCE CHAIRPERSON Moira Daniels, Vice President, Head of Regulatory Affairs, UCB

Sini Eskola, Director, Regulatory Affairs,
European Federation of Pharmaceutical Industries and Associations (EFPIA)

Greet Musch, General Director, Pre-Marketing Authorisation,
Federal Agency for Medicines and Health Products (FAMHP), Belgium

Christopher Price, Manager, Global Regulatory Affairs – Oncology, Merck KGaA

Marianne Andersson, MSc Pharm,
Lead, Regulatory Processes & Partnerships, AstraZeneca

Matthias Zerm, PhD, Global Clinical Development, Lead Expert,
Clinical Trial Disclosure and R&D Processes, Merz Pharmaceuticals GmbH

Key Attendee Benefits:

  • Gain in-depth insight into the EU Clinical Trial Portal and Database
  • Evaluate the common themes of the EU Clinical Trials Regulation
    (CTR), the EU Medical Devices Regulation (MDR) and the
    EU General Data Protection Regulation (GDPR)
  • Hear How Brexit Could Impact the Implementation of the
    EU Clinical Trial Portal
  • Identify best practices for establishing a successful
    lay summaries process
  • Take a look at Belgium’s national pilot program for
    implementing the EU guidelines

We'll see you there!