Collaborative Regulatory Training Seminar 2016: Challenges & Issues with Registration & Variation Applications (9 – 10 March 2016)
This training seminar is jointly organised by the Pharmaceutical Association of Malaysia (PhAMA), Malaysian Organisation of Pharmaceutical Industries (MOPI) and Malaysian Association of Pharmaceutical Suppliers (MAPS) in collaboration with the National Pharmaceutical Control Bureau (NPCB), Ministry of Health Malaysia.
The purpose of this seminar is for the industry to acquire a better understanding of the drug registration and variation requirements in Malaysia. Registration experts from NPCB will be covering common issues/problems encountered with the industry’s submissions for drug registrations and gaps in understanding of NPCB’s registration requirements, with case studies and clarification on the more challenging sections of the guidelines, as well as Do’s & Don’ts and other advice for industry personnel to be more competent in generating registration applications of high quality and to obtain timely approvals from the Drug Control Authority (DCA).
Who should attend:
Key personnel involved in the drug registration submissions with NPCB and management of these registration applications for timely approvals from the DCA. Product Registration Holders/ applicants (PRH) and Regulatory Managers/ Executives are encouraged to attend.
Brochure Download here Pdf File