The Health Products Regulation Group (HPRG) of the Health Sciences Authority (HSA) will be organising a Joint Regulatory Workshop from 15 to 17 February 2012 at the Swissotel Merchant Court.
Our 2nd joint workshop aims to provide a good platform for industry participants to further their understanding of the regulatory requirements for western medicines, medical devices, clinical trials on medical devices, complementary health products, cosmetic products and Good Manufacturing Practice.
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WORKSHOP DETAILS
Date: 15 to 17 February 2012
Location: Swissotel Merchant Court
20 Merchant Road, Singapore 058281
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WORKSHOP PROGRAMME
Date | Topic |
15 Feb 2012 AM Session | Regulatory Controls of Medicinal Products · Updates on the Health Products (Therapeutic Products) Regulations · Dossier Filing for New Products · MIV Consequential Changes |
15 Feb 2012 | Good Manufacturing Practice for Medicinal Product · Update on PIC/S GMP Standard · Revision of Site Master File Guidance · Case Study Presentations |
16 Feb 2012 AM Session | Regulatory Controls of Medical Devices · Updates on the Health Products (Medical Device) Regulations · Approach to Evaluation Reviews of Combination Products |
16 Feb 2012 PM Session | Medical Device Clinical Trials · Overview of the Approach to Regulating Clinical Trials · Updates on the Health Products (Clinical Trials) Regulations · Safety Reporting in Medical Device Clinical Trials |
17 Feb 2012 AM Session | Regulatory Controls of Complementary Health Products · Introductory notes on ASEAN and local developments in the area of complementary health products · Overview of ASEAN & ASEAN Traditional Medicines and Health Supplements Product Working Group (TMHSPWG) · Developments on technical requirements under ASEAN TMHSPWG
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17 Feb 2012 PM Session | Regulatory Controls of Cosmetic Products · ASEAN Cosmetic Directive and its Implementation in Singapore · Notification Procedures · Labelling Requirements and Guidelines on Cosmetic Claims · Management of Adverse Event Reports · Preparation of Product Information File |
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- Please note that the programme may be subject to change.
- Please click here for the online registration form. The closing date for registration is 31 January 2012.
- Registration is on a first-come-first-serve basis due to limited seats.
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For further information about registration, please contact the Conference Secretariat:
Tel: (65) 6295 5478
Fax: (65) 6295 5120
Email: HSA.JRW@gmail.com
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