09 Jul 2019 - 10 Mar 2019 Past Event

Collaborative Regulatory Training Seminar 2016

Venue: Ballroom, Eastin Hotel
Theme: Challenges & Issues with Registration & Variation Applications

Downloads:

  1. Brochure - PDF, 300 KB
  2. Registration Form - DOCX, 28 KB
  3. Accommodation Form - DOCX, 28 KB

 

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