Venue: Ballroom, Eastin Hotel
Theme: Challenges & Issues with Registration & Variation Applications
Downloads:
Introduction
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.
Day 1: Challenges & Issues with Product Registrations (Screening & Evaluation)
Time | Topic | Presenter |
08:00-09:00 | Seminar Registration by participants (Morning Tea/Coffee) |
|
09:00-09:15 | Welcome & Opening | Mr Tan Ann Ling, NPCB Director |
09:15-10:00 | Registration Challenges & Issues (General) | Datin Zahura Mohamed@Ismail |
10:00-10:45 | FDI & Medical Device-Drug Classification | Pn Fatimah Azman / Pn Su Siew Ching |
10:45-11:15 | TEA/COFFEE BREAK | |
11:15-12:15 | Common Registration Issues with BA/BE, Poisons and OTC applications |
BA/BE : Cik Khirul Falisa Mustafa Generik (Poison) : Pn Cynthia Albert Gunaratnam Generik (Non-Poison) : Pn Suhailah Abu Bakar |
12:15-13:00 | Common Registration Issues with Biologics applications | Dr Yvonne Khoo Siew Khoon |
13:00-14:00 | LUNCH BREAK | |
14:00-14:40 | Common Registration Issues with NCE applications | Pn. Azura Abdullah / Pn. Chuah Su Yin Florence |
14:40-15:10 | Common Registration Issues with Health Supplement applications | Pn. Ong Swan Wui |
15:10-15:40 | Common Registration Issues with Traditional Medicine applications | Pn. Nordalila Sabuan |
15:40-16:10 | Common Registration Issues with API applications | Pn. Roslina Ibrahim |
16:10-16:30 | End of day Q&A session | |
16:30-17:00 | Tea/Coffee |
Day 2: Challenges & Issues with Variations (Screening & Evaluation)
Time | Topic | Presenter |
08:00-08:30 | Registration (Morning Tea/Coffee) | |
08:30-09:30 | Common Variation Issues with Pharmaceuticals (NCE, Poison, OTC) |
NCE : Pn Siti Hidayah Kasbon (Poison & OTC Non Poison) : Ms Evelyn Loh |
09:30-10:30 | Common Variation Issues with Biologics | Pn. Jenny Thong Chen Ni |
10:30-11:00 | Tea/Coffee Break | |
11:00-12:00 | Common Variation Issues with Complementary Medicines (Health Supplements & Traditional Medicines) | HS : Ms Kam Kher Li Trad : Ms Kong Su Yi |
12:00-11:30 | Update on Orphan Drugs Designation & Registration | Pn. Anis Talib/Pn Azura Abdullah |
12:30-13:00 | Q&A session | |
13:00-14:00 | Closing /Lunch |