(Recorded on January 9th, 2014) | Access Today
For over 20 years, regulatory agencies have sought to harmonize the safe and effective development, manufacture and distribution of treatments and therapies. With increasing globalization and stringency naturally come some sticking points among global regulatory bodies. A drug approved in the EU is not necessarily approved in the US, or vice versa, for example.
What are the steps required for national regulatory agencies to achieve a harmonization in drug approvals and manufacture? As another, US and EU regulators are often inspecting the same third-party active pharmaceutical ingredient (API) manufacturers in India and other places but don’t share reports easily or automatically. What is required to improve cooperation? How are companies reacting to these ever evolving changes? How can technology play a role in ameliorating risks and confusion across borders?
This webinar will address some of the key issues and challenges ahead in achieving global regulatory harmonization.
- Meredith Brown-Tuttle, Principal Consultant, Regulatorium
- Yohan Lee, PhD, Cloud Analytics, Booz Allen Hamilton
- Jaleel Shujath, OpenText
Cost: No cost!