OECD Workshop on Mutual Acceptance of Data, Good Laboratory Practice and Compliance Monitory (4-5 December 2007)

The Malaysian Biotechnology Corporation, jointly with the Ministry of Health (MoH), Malaysian Institute of Pharmaceutical and Nutraceutical (IFNM) and the Organisation for Economic Cooperation and Development (OECD), organised this workshop on the OECD framework for Mutual Acceptance of Data (MAD), Good Laboratory Practice and compliance monitoring. The workshop was held on the 4th and 5th of December 2007 at The Ritz-Carlton Kuala Lumpur. The workshop was officiated by Tan Sri Datuk Dr Hj. Mohd. Ismail Merican, Director General of MoH. In his opening remarks Tan Sri Ismail noted GLP’s importance and Malaysia’s efforts toward implementing the OECD GLP framework in Malaysia.

The workshop aimed to introduce the basic principles of good laboratory practice (GLP) as outlined by the OECD’s framework to prospective researchers and industrial players in the field of drug development and discovery. These OECD Principles of Good Laboratory Practice are applicable to the non-clinical safety testing of test items contained in pharmaceutical products, modernised traditional products in pharmaceutical dosage form and cosmetic products, medical devices, biocides, biotechnology products, industrial chemicals and agricultural chemicals.

OECD’s framework of GLP sets out managerial concepts and procedures on the organisation of testing facilities as well as the conditions under which testing is carried out. This is to ensure the high quality and reliable test data from testing, in the framework of harmonising testing procedures for the Mutual Acceptance of Data (MAD).

The workshop was conducted by the following experts from the Environment Directorate of OECD and the OECD-member country GLP agencies:

• Dr. Dian Turnheim, Deputy Head of Division, Environment, Health and Safety Division (OECD)
• Mr Hedwig Beernaert, Quality Assurance and GLP Manager, Scientific Institute of Public Health (Belgium)
• Ms Francisca Liem, Chief, Laboratory Data Integrity Branch, US Environmental Protection Agency (USA)
• Ms Katariina Rautalahti, Head of Department in the National Product Control Agency for Welfare and Health (Finland)
• Ms Louise Calder, Manager – GLP Programme, National Association of Testing Authorities (Australia)
• Prof. Dato’ Dr. Mohamed Isa Abd. Majid, Director of Malaysia Institute of Pharmaceuticals and Nutraceuticals, Ministry of Science, Technology and Innovation (Malaysia)

Please click for the presentation slides.