Menu Back toWelcome to Day Two and Session 6: International Regulations and the Impact on Global Clinical Research

Global Clinical Trial Disclosure and Data Transparency Conference

Learn about the latest requirements in clinical trial disclosure and data transparency, share best practices, and engage in in-depth discussions on hot topics.


Welcome to Day Two and Session 6: International Regulations and the Impact on Global Clinical Research

Session Chair(s)

Merete  Joergensen, MBA, MSc

Merete Joergensen, MBA, MSc

  • Senior Director, Clinical Transparency
  • Novo Nordisk A/S, Denmark
In a landscape of global clinical research attention to international regulations play an important role. Harmonization to the extent possible has an impact on making research conduct more ethical i.e. less need for repeat of trials/randomization of patients into trials already conducted elsewhere. Bringing products to patients earlier when trials are globally acceptable for new medical product approval. This session’s presentations will provide insight into some of the international regulations such as playing a role in achieving transparency of the landscape of clinical research, efficiency by harmonization and collaboration of regulators review and approval of new drugs/devices, and considerations for options for harmonization of data privacy rules and consequences related to data sharing across borders
Learning Objective : At the conclusion of this session, participants should be able to:
  • Recognize the importance of focus on global harmonized approach to clinical research and the benefit for society
  • Appraise the roles and rules behind of Global Clinical Trials registries versus the National Clinical Trials registries
  • Assess and organize in relation to global data privacy rules

Speaker(s)

Ghassan  Karam, MSc

Speaker

Ghassan Karam, MSc

  • Manager International Clinical Trials Registry Platform (ICTRP)
  • World Health Organization (WHO), Switzerland
Jenny  Petersen

Speaker

Jenny Petersen

  • Director, Clinical Trial Disclosure and Transparency
  • Alnylam Pharmaceuticals, United States
Jeppe G.  Manuel, MLIS

Speaker

Jeppe G. Manuel, MLIS

  • Principal R&D Data Privacy Specialist
  • Novo Nordisk, Denmark