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