Slides for National Regulatory Conference 2013

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Date : 13 May 2013

Category : Other News and Important Annoucements

National Regulatory Conference 2013


Day 1 : 7th May 2013 (Tuesday)

Plenary 1 : Updates on Current and Future Regulatory Developments in Malaysia

Plenary 2 : Malaysia Adherence to Organization For Economic Cooperation and Development (OECD) - Good Laboratory Practice (GLP) Mutual Acceptance of Data (MAD) System


 Track 1:

Traditional Medicines and
Health Supplements (THMS)

Track 2:

Pharmaceutical Products 

Track 3:

 Biologic Product

Herbal Product Development in Malaysia The Way Forward for Local Pharmaceutical Industries  Clinical Considerations for Biosimilars and Existing Regulatory Guidance
  Quality Risk Management  
Integration of Traditional Medicine into Allopathic Healthcare System Implementation of Bioequivalence Study for Generic Medicines in Malaysia Cell and Tissue Therapies : Current Trend and Challenges 
Guidelines on Higher Claims for Complementary Medicine in Malaysia  Design Updates and Requirements in Bioequivalence Study  Malaysian Vaccine Programme : Pathway for Malaysia's Nascent Vaccine Industry 



Day 2 : 8th May 2013 (Wednesday)

Plenary 3 : Regulation of Cellular and Gene Therapy Products (CGTPs) in Malaysia

Plenary 4 : Global Regulatory Trends - Challenges and Implications 'Is Asia Breaking Out of the Age of Innocence?'

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

Plenary 6 : Supply Chain Management

Plenary 7 : Current Global Landscape of Pharmacovigilance


Track 1:

Traditional Medicines and
Health Supplements (TMHS)

Track 2:

Pharmaceutical Products

Track 4:

Cosmetic Products

Standardization of Herbal Extract Nano Mmedicines in Pharmaceuticals  New Breakthrough in Cosmetic : Skin Measurement Methodology Development 
Non-Clinical Studies for Herbal Products Risk Benefit Assessment and Risk Management Safety Assessment of Cosmetics
Global Trends in Health Supplement Regulations Understanding the Similarities and Differences between Innovator and Biosimilar Comparability Exercise Cosmetic Advertising & Product Claim
Trending of Adulteration - Adverse Drug Reactions (ADR) in THMS Products Updates on Malaysian Variation Guidelines for Pharmaceutical  Product Information File (PIF) : What to Expect from the Audit?  


Day 3 : 9th May 2013 (Thursday)

Plenary 8 : Updates on National Medicines Policy (DUNAS)

Plenary 9 : Halal Pharmaceuticals - A Regulator's Perspective - MS 2424

Plenary 10 : Pharmacy Legislative Transformation

Plenary 11 : Advertisement - Self-Regulation and Enforcement

Plenary 12 : Regulation of Medical Devices in Malaysia

Plenary 13 : QUEST3+ - Issues and Challenges



National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400



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