戻る Agenda
Welcome to Day Two and Session 6: International Regulations and the Impact on Global Clinical Research
Session Chair(s)
Merete Joergensen, MBA, MSC
Clinical Disclosure and Transparency Expert
Merete-J Consulting, 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)
Speaker
Ghassan Karam, MSC
World Health Organization (WHO), Switzerland
Manager International Clinical Trials Registry Platform (ICTRP)
Speaker
Jenny Petersen
Alnylam Pharmaceuticals, United States
Director, Clinical Trial Disclosure and Transparency
Speaker
Jeppe G. Manuel, MLIS
Novo Nordisk, Denmark
Principal R&D Data Privacy Specialist