Standards of evidence for regulatory decision making
- At: 2017 FIP Congress in Stockholm (Sweden)
- Type: Presentation
- By: HEMMINGS, Robert (MHRA, Licensing Division, London, United Kingdom)
- Co-author(s): Robert Hemmings: Licensing Division, MHRA, London, United Kingdom
Regulators encourage early dialogue with companies planning strategies for global drug development, licensing and commercialisation. That diagloue helps to define a path for the development, including standards for licensing, different methodological approaches in clinical trial design, conduct and analysis, and regulatory tools to support.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.