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Transformation Towards A New Regulatory Paradigm
N A T I O N A L R E G U L A T O R Y C O N F E R E N C E
A u g u s t 4 – 6 , 2 0 1 5
O n e W o r l d H o t e l
P e t a l i n g J a y a
JOINTLY ORGANIZED BY:
N A T I O N A L R E G U L A T O R Y C O N F E R E N C E
2015
REGISTRATION FORMPARTICIPANT DETAILS
Title:
(Datuk / Dato’ / Datin / Dr / Mr / Mdm / Ms)
Full Name:
Job Title:
Organisation:
Mailing Address:
Postcode: Country:
Preferred Name on Name Tag:
Telephone:
Email:
Vegetarian
Date: ..........................................Signature:
Non Vegetarian
Meal Request: Please tick ( )
PREFERRED TRACK: Please tick ( )
Conference Day 2 (5th August 2015)
Track 1 (THMS)
Track 2 (Pharmaceutical & Biologic Products)
HOW TO REGISTER
REGISTRATION FEE
MODE OF PAYMENT
Submit your completed registration form with your proof of payment (cheque/bank draft/copy of bank deposit receipt) before 15th July 2015 to:
NRC Secretariat 2015Centre for Post Registration of ProductsNational Pharmaceutical Control BureauMinistry of Health MalaysiaLot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
For enquiries on registration, kindly contact:Name : Mr. Chai / Ms. Vi Vian / Ms. SafiyaTelephone : +603-7883 5542 / +603-7801 8461 / +603-7801 8546Email : [email protected] / [email protected] / [email protected] : +603-7956 7151
Please tick ( ) in the box:
Please tick ( ) in the box:
Local: RM2,000 (early bird, with payment before 30th June 2015)
Local: RM2,200 (after 30thJune 2015)
Government: RM1,200
Single track (TMHS only): RM1,000
Overseas: USD650 (early bird, with payment before 30th June 2015)
Overseas: USD700 (after 30th June 2015)
Note: All fees are inclusive of 6% Goods and Service Tax (GST)
� By Cheque � Bank draft � LPO No: .............................................
For the sum of RM/USD .................................................................................. Payment should be made payable to Malaysian Pharmaceutical Society.
� By Direct bank transfer/ ATM into the conference bank account “M alaysian Pharmaceutical S ociet y ”.
Account No: 0-14271-31967-2 (Swiftcode: MBBEMYKL). Address: Malaysian Banking Berhad, Lorong Rahim Kajai 14, Taman Tun Dr. Ismail, 60000 Kuala Lumpur, Malaysia. Please send/email/fax the bank receipt to MPS to confirm your registration.
� By Credit Card For the sum of RM/USD .............................................
� Visa Master Card Diners Club American Express
Card No.: ..............................................................................................................
Name of Cardholder: ............................................ Expiry Date:.................
Signature of Cardholder: ................................................................................Note: Malaysian participants, please pay in Malaysian Ringgit (RM).
August 4 – 6, 2015 One World Hotel Petaling Jaya
TERMS & CONDITIONSRegistrat ion fee includes refreshments, lunch & official d inner. Accommodation is not included
Registrat ion wi l l be c losed on 15th July 2015.
No refund wi l l be given upon cancel lat ion. However, a replacement wi l l be accepted at no cost with consent of the Secretar iat .
Please contac t hotel d i rec t ly for Hotel Reser vation: One Wor ld Hotel , 3259, Fi rst Avenue, Bandar Utama Cit y Centre, 47800 Petal ing Jaya, Selangor, Malays ia Tel : +603-7681 1111; Fax +603-7681 1188; Emai l : reser vat ions@oneworldhotel .com.my
For enquir ies on fee payment, please contac t :M alaysian Pharmaceutical S ociet y (MPS)16-2 Jalan OP 1/5, 1-Puchong Business Park , O ff J ln. Puchong, 47160 Puchong, S elangor.Tel : +603-8079 1861| Fax: +603-8070 0388Email : [email protected] ing.my
T r a n s f o r m a t i o n T o w a r d sA N e w R e g u l a t o r y P a r a d i g m
2 015
NationalPharmaceutical
Control Bureau
&
N A T I O N A L R E G U L A T O R Y C O N F E R E N C E 2 015
7.30am – 9.00am REGISTRATION
9.00am – 9.10am Welcoming Remarks Y. Bhg. Dato’ Eisah A. Rahman Senior Director of Pharmaceutical Services, Ministry of Health Malaysia
9.10am – 9.30am Opening Ceremony YB Datuk Seri Dr. S. Subramaniam Minister of Health Ministry of Health Malaysia
9.30am – 10.00am Key Note Address Y. Bhg. Datuk Dr. Noor Hisham Abdullah Director General of Health, Ministry of Health Malaysia
10.00am – 10.30am COFFEE BREAK
10.30am – 11.30am Plenary 1: Update on ACCSQ PWG - “Impact of ASEAN Harmonisation on Current Regulatory Framework in Malaysia (Pharmaceuticals and TMHS)” and Malaysian Regulatory Update Mr. Tan Ann Ling Director, National Pharmaceutical Control Bureau (NPCB)
11.30am– 12.30pm Plenary 2: Regulation of Orphan Drug from EMA Perspective Prof. Bruno Sepodes Chair, Committee of Orphan Medicinal Products, European Medicines Agency (EMA)
12.30pm – 2.00pm LUNCH
2.00pm – 3.00pm Plenary 3: An Introduction to Quality by Design with Case Study Dr. Elisabeth Kirchisner Director Technical Regulatory Affairs, Roche Diagnostics GmbH, Penzberg, Germany
3.00pm – 3.45pm Plenary 4: Cell and Gene Therapy Product Guideline in Malaysia Dr. Azizah Ab. Ghani Head of Biotechnology Section, Centre for Product Registration, NPCB
3.45pm – 4.30pm Plenary 5: Monitoring Drug Safety in the Market – Role of Industry Dr. Jean-Christophe Delumeau Head of Pharmacovigilance Asia-Pacific and China, Bayer HealthCare / Bayer South-East Asia
4.30pm – 5.30pm Plenary 6: Life-Cycle Management of Pharmaceutical Products and ICH Q12 Concepts Dr. Markus Goese EMA Liaison, F. Hoffman-La Roche Ltd., Basel, Switzerland
5.30pm ADJOURNED & COFFEE
DAY 2: 5 August 2015 (WEDNESDAY)
Track 2:Pharmaceutical and Biologic ProductsChairperson: Ms. Hasniza Zaidan, NPCB
Regulatory Overview and Considerations of Biologics & BiosimilarsDr. Yvonne Khoo Siew Khoon, NPCB
Strengthening of the Regulatory Oversight of Vaccine in MalaysiaMs. Noorul Akmar, NPCB
Cold Chain Inspection: Regulatory Perspective on Current Strategies and Future Demands Ms. Nora Ashikin Md. Ali, NPCB
12.30pm – 1.00pm Q & A
1.00pm – 2.00pm LUNCH
Track 1: Traditional Medicines and Health Supplements (TMHS) Chairperson: Datin Shantini Thevendran, NPCB
2.00pm – 2.30pm Herbal Monograph Development in Malaysia Dr. Ami Fazlin Syed Mohamed Institute of Medical Research, Ministry of Health Malaysia
2.30pm – 3.30pm Regulatory Requirements for Traditional Medicine and Health Supplement Products by China FDA Speaker from China FDA
3.30pm – 4.00pm T&CM Act - What Should You Know? Ms. Teh Li Yin Traditional and Complementary Medicine Division, Ministry of Health Malaysia
4.00pm – 4.30pm Q & A
4.30pm – 5.00pm ADJOURNED & COFFEE
7.30pm OFFICIAL DINNER
BA/BE Update Focusing on BiowaiverMs. Mazuwin Zainal Abidin, NPCB
Track 1: Traditional Medicines and Health Supplements (TMHS) Chairperson: Ms. Mazli Muhammad, NPCB
9.00am – 10.00am Regulatory Challenges and Benefits/ Perspectives for Herbal and Health Supplements Combinations Dr. Lesley Braun Blackmores Institute , Australia
10.00am – 10.30am Regulatory Requirements for TMHS & Herbal Products from Malaysia Perspective - Criteria for the Evaluation of Safety, Efficacy and Quality Aspects of Drugs Ms. Seetha Ramasamy, NPCB
10.30am – 11.00am COFFEE BREAK
11.00am – 11.30am Quality Control Aspects for Herbal Product with High or Medium Claim Dr. Noraida Mohamad Zainoor, NPCB
11.30am – 12.00pm Classification of Food-Drug Interphase Products Ms. Salasiah Abdullah, NPCB
12.00pm – 12.30pm The Value of Herbal Products: From R&D to Commercialization Dato’ Dr. Rajen Holista Biotech Sdn. Bhd.
PLENARY SESSIONChairperson: Dr. Kamaruzaman Saleh, NPCB
PLENARY SESSIONChairperson: Ms. Anis Talib, NPCB
PLENARY SESSION Chairperson: Ms. Siti Aida, NPCB
Risk Management Plan (RMP) on Biologicals and NCEMr. Teruyoshi Ehara Office Director, Office of International Programs, Pharmaceutical and Medical Device Agency (PMDA)
Track 2:Pharmaceutical and Biologic ProductsChairperson: Ms. Rokiah Isahak, NPCB
Regulatory Control of API in MalaysiaDatin Zahura Mohamed @ Ismail, NPCB
Q & A
Data Exclusivity on Biologicals, IP - Patent Issues from International PerspectivesMr. Michael Muna Senior Director, Regulatory Affairs International, BioMarin Pharmaceutical Inc.
Updates on Veterinary Product Registration in MalaysiaMs. Asnida Mat Daud, NPCB
Q & A
8.30am – 9.15am Plenary 7: Quest 3+: Updates on Registration Process Ms. Rosilawati Ahmad Head of Regulatory Coordination Section, Centre for Product Registration, NPCB
9.15am – 10.00am Plenary 8: Developing the Local Pharmaceutical Industry through NKEA Healthcare Mr. Choy Lup Bong Undersecretary, Policy and International Relations Division, Ministry of Health Malaysia
10.00am – 10.30am COFFEE BREAK
10.30am – 11.30am Plenary 9: New Initiative for Good Registration Management from Industry Perspective - Enhancing Good Submission Practices by APAC Mr. Kiminori Nagao APAC RA-EWG Director
11.30am – 1.00pm Plenary 10: Initiatives for the Promotion of the Healthcare Industry (1) MOSTI Speaker from MOSTI
(2) MIDA Speaker from MIDA
(3) PEMANDU Mr. Fabian Bigar Director, Healthcare NKEA, Economic Transformation Programme, Performance Management and Delivery Unit (PEMANDU), Prime Minister’s Department
1.00pm – 1.15pm Closing Remarks Mr. Tan Ann Ling Director, National Pharmaceutical Control Bureau (NPCB)
1.15pm ADJOURNED & LUNCH
DAY 1: 4 August 2015 (TUESDAY) DAY 3: 6 August 2015 (THURSDAY)
