Head of Global Regulatory Affairs and Compliance Trident Pharmaceuticals limited & Spinos Clinical Research Uk Leicester, England, United Kingdom
This presentation will provide an overview of the regulatory agencies, as well as the key laws, regulations and opinions. Through several case studies, the key regulatory pathways will be illustrated and the presenter will give some insight from her personal and recent experiences. Attendees will benefit from a most current account and if interested, can follow up on details through the many links given in the presentation.
Contact and communicate with the correct agency depending on the selected approval pathway
Understand the benefits and challenges of the various regulatory pathways currently available in China
Identify, which products are accepted for expedited approvals and why