6 MONTH PART-TIME DIPLOMA IN PHARMA REGULATORY AFFAIRS

AIPS is introducing this training course for all those seeking a career in the field of Drug Regulatory Affairs in the pharmaceutical industry. The course has been specially designed keeping in the mind the needs of the Indian Pharmaceutical industry, and the course contents include.

Introduction to Regulatory Affairs

Good Manufacturing Practices, QA and Regulation

ICH

Dossier preparation and CTD Compilation

Pharma Regulatory Regime in the U.S., EU, Japan, India and Rest of the World

Clinical Investigational Studies

Pharma Patents, IPR and Regulation

Electronic Submissions

To register, please e-mail info@aips.ac.in

One day Seminar on PATENT STRATEGIES FOR PROTECTING INVENTIONS IN U.S., EUROPE & INDIA

Academy of Intellectual Property Studies, Intellectual Property Management - Mumbai, India organizes a one day seminar that will look at the challenges and pitfalls faced while prosecuting patents in the U.S., Europe and India, and suggest strategies that can be adopted to protect biotech and pharmaceutical inventions. IP challenges for biosimilars will also be studied, including freedom -to - operate issues, the regulatory pathway for approval of biosimilars, and the related IP strategies for innovator and generics companies. A combination of US and EP perspectives in a single event, supplemented by some specific aspects of national Indian law, will add value to the event.

Dates January 18, 2011

For further information, send in youre-mails to info@aips.ac.in