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International Good Manufacturing Practice Training 2017

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International Good Manufacturing Practice Training Program 2016

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Collaborative Regulatory Training Seminar 2016

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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.


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Registration Form
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The Malaysian Organisation of Pharmaceutical Industries (MOPI) was incorporated on March 6th 1981, as a company limited by guarantee, by eight local, foreign and joint venture companies involved in the manufacture of pharmaceutical products......Readmore

 

 

 

Contacts

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Tel:  +603-7931 9003
Fax: +603-7932 2730
Address:  GLOBAL BUSINESS & CONVENTION CENTRE, MEZZANINE FLOOR, BLOCK A, NO. 8, JALAN 19/1, SECTION 19, 46300 PETALING JAYA, SELANGOR DARUL EHSAN, MALAYSIA