NATIONAL REGULATORY CONFERENCE 2013

NATIONAL REGULATORY CONFERENCE 2013 DAY 1: 7 May 2013 ... National Pharmaceutical Control Bureau (NPCB ... Mutual Acceptance of Data …...

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NATIONAL REGULATORY CONFERENCE 2013 DAY 1: 7 May 2013 (TUESDAY) 7.30am – 9.00am 9.00am – 9.15am

9.15am – 9.30am

9.30am – 10.00am 10.00am – 10.30am

Registration Welcoming Remarks Y. Bhg. Dato’ Eisah A. Rahman Senior Director of Pharmaceutical Services, Ministry of Health Malaysia

Opening Ceremony Y.B. Dato’ Sri Liow Tiong Lai Minister of Health Malaysia

Key Note Address

Y. Bhg Datuk Dr. Noor Hisham Abdullah Director General of Health, Ministry of Health Malaysia

COFFEE BREAK

MORNING PLENARY SESSION Chairperson: Dr. Tajuddin Akasah, National Pharmaceutical Control Bureau (NPCB), Ministry of Health (MOH)Malaysia 10.30am – 11.30am

11.30am– 12.30pm

Plenary 1:Updates on Current and Future Regulatory Developments in Malaysia Mr. Tan Ann Ling Director, National Pharmaceutical Control Bureau (NPCB), Ministry of Health (MOH)Malaysia

Plenary 2:Malaysia Adherence to Organisation for Economic Cooperation and Development (OECD) Good Laboratory Practice (GLP) Mutual Acceptance of Data (MAD) System Dr. Hasenah Ali Head of GLP Section, NPCB, MOH

12.30pm – 2.00pm

LUNCH

AFTERNOON TRACK SESSIONS

2.00pm – 2.30pm

Track 1: Traditional Medicines and Health Supplements (TMHS)

Track 2: Pharmaceutical Products

Chairperson: Ms. Mazli Muhammad NPCB

Chairperson: Mr. Radzmi Rahmat Malaysian Association of Pharmaceutical Suppliers (MAPS)

Herbal Product Development in Malaysia

The Way Forward for Local Pharmaceutical Industries

Hj Ibrahim bin Saleh Delivery Management Office, Ministry of Agriculture (MOA)

Helping SME industries to Go Global 2.30pm – 3.00pm

3.00pm – 3.30pm

Mr. Azman Md. Yusof Malaysia External Trade Development Cooperation (MATRADE)

Integration of Traditional Medicine into Allopathic Healthcare System Dr. Zalilah Abdullah Traditional & Complimentary Medicine Division, MOH

Mr. Jamaludin Elis Pharmaniaga Manufacturing Berhad

Quality Risk Management Mr. Steve Slater Traque Asia, Singapore

Implementation of Bioequivalence Study for Generic Medicines in Malaysia Ms. Mazuwin Zainal Abidin NPCB

Track 3: Biologic Products

Chairperson: Ms. June Oi Pharmaceutical Association of Malaysia (PhAMA)

Clinical Considerations for Biosimilars and Existing Regulatory Guidance Dr Martina Sersch Genentech/ F. Hoffmann-La Roche

Cell and Tissue Therapies: Current Trend and Challenges Prof Dr. Ruszymah Hj Idrus Tissue Engineering Centre, UKM Medical Centre

Malaysian Vaccine Programme: Pathway for Malaysia's Nascent Vaccine Industry

Guidelines on Higher Claims for Complementary Medicine in Malaysia

Design Updates and Requirements in Bioequivalence Study

Datin Shantini Thevendran NPCB

Dr. Lee Toong Chow Info Kinetics Sdn. Bhd.

Mr. Jay Padasian, Malaysian Biotechnology Corporation (BiotechCorp)

4.00pm – 4.30pm

Q&A

Q&A

Q&A

4.30pm – 5.00pm

ADJOURN & COFFEE

7:30pm

OFFICIAL DINNER

3.30pm – 4.00pm

DAY 2: 8 May 2013 (WEDNESDAY) MORNING PLENARY SESSION

Chairperson: Dr. Kamaruzaman Saleh, National Pharmaceutical Control Bureau (NPCB), Ministry of Health (MOH)Malaysia 8.30am – 9.15am

9.15am – 10.00am

Plenary 3:Regulation of Cellular and Gene Therapy Products (CGTPs) in Malaysia Ms. Arpah Abas Head of Biologics Section, NPCB, MOH

Plenary 4:Global Regulatory Trends: Challenges and Implications – Is Asia Breaking Out of the Age of Innocence? Mr. Chew Kwee Tat Director, Regulatory Strategist, Strategic Drug Development Asia, Quintiles East Asia Pte Ltd. , Singapore

10.00am – 10.30am

COFFEE BREAK

10.30am – 11.15am

Plenary 5:Biotherapeutics: What’s Right for Patients Moving Forward?

11.15am – 12.00am

Plenary 6:Supply Chain Management

12.00am – 12.45pm

Plenary 7:Current Global Landscape of Pharmacovigilance

12.45pm – 2.00pm

LUNCH

Karen M. Hauda Senior Director, Biotherapeutic Strategic Initiatives, AbbVie Inc., United States of America

Mr. Steve Slater Director, Traque Asia, Singapore

Dr. Pia Caduff-Janosa Chief Medical Officer , Uppsala Monitoring Centre(UMC), Sweden

AFTERNOON TRACK SESSIONS Track 1: Traditional Medicines and Health Supplements (TMHS) Chairperson: Dato’ Dr Rajen M Malaysian Dietary Supplement Association (MADSA)

Track 2: Pharmaceutical Products Chairperson: Mr. Jimmy Piong Malaysian Organisation of Pharmaceutical Industries (MOPI)

Standardization of Herbal Extract

Nano Medicines in Pharmaceuticals

Prof. Zhari Ismail Universiti Sains Malaysia (USM)

Assoc. Prof. Shaharum Shamsuddin Universiti Sains Malaysia (USM)

2.30pm – 3.00pm

Non-Clinical Studies for Herbal Products

Risk Benefit Assessment and Risk Management

3.00pm – 3.30pm

Global Trends in Health Supplement Regulations

2.00pm – 2.30pm

Dr. Zakiah Ismail, Institute Medical Research (IMR), MOH

Ms. Michelle Stout Amway Corporation, CA, USA

Track 4: Cosmetic Products

Chairperson: Mr. Seng San Bing Federation of Malaysian Manufacturers-Malaysian Cosmetics and Toiletries Industry Group (FMM-MCTIG)

New Breakthrough in Cosmetic: Skin Measurement Methodology Development

Dr Kukizo Miyamoto, P & G Japan

Safety Assessment of Cosmetics

Dr. Pia Caduff-Janosa UMC, Sweden

Mr. Mohd Helme Mohd Helan, SIRIM Berhad

Understanding the Similarities and Differences Between the Innovator and Biosimilar Comparability Exercise

Cosmetic Advertising & Product Claim

Karen M. Hauda AbbVie Inc., USA

Ms. Zuraida Abdullah NPCB

Updates on Malaysian Variation Guidelines for Pharmaceutical

Ms. Basmiah Md. Isa, NPCB

Mr. Chai Che Leong NPCB

Product Information File (PIF): What to Expect from The Audit?

4.00pm – 4.30pm

Q&A

Q&A

Q&A

4.30pm – 5.00pm

ADJOURN & COFFEE

3.30pm – 4.00pm

Trending of Adulteration – Adverse Drug Reactions (ADR) in TMHS Products

Ms. Nik Shamsiah Nik Salleh NPCB

DAY 3: 9 May 2013 (THURSDAY) PLENARY SESSION

Chairperson: Mr. Sulaiman Hj Ahmad, National Pharmaceutical Control Bureau (NPCB), Ministry of Health (MOH)Malaysia 8.30am – 9.15am

Plenary 8:Updates on National Medicines Policy (DUNAS)

9.15am – 10.00am

Plenary 9: Halal Pharmaceuticals: A Regulator’s Perspective – MS 2424

10.00am – 10.45am

Plenary 10:Pharmacy Legislative Transformation

10.45am – 11.15am

COFFEE BREAK

11.15am – 12.00pm

Plenary 11:Advertisement: Self-Regulation and Enforcement

12.00pm – 12.45pm

Plenary 12:Regulation of Medical Devices in Malaysia

12.45pm – 1.15pm

Plenary 13:QUEST 3+: Issues and Challenges

Dr. Salmah Bahri Director of Pharmacy Practice and Development, Pharmaceutical Services Division, MOH

Dr. Tajuddin Akasah Deputy Director, NPCB, MOH

Mr Mohd Zulkifli Bin Abdul Latif Deputy Director, Legislation, Pharmacy Enforcement, Pharmaceutical Services Division, MOH

Mr. Muhammad Lukmani Ibrahim Secretary of Medicine Advertisement Board, MOH

Mr. Zamane Abd Rahman Chief Executive Officer, Medical Device Authority, MOH

Ms. Siti Aida Abdullah Deputy Director, NPCB, MOH

1.15pm – 1.30pm

Closing remarks Mr. Tan Ann Ling Director, National Pharmaceutical Control Bureau (NPCB), MOH

1.30pm

LUNCH