Back to Calendar of events   Presentation slides Programme Tuesday, 4 December 2007 Time Agenda Speaker Presentation slides I. Welcome and Opening 0800 - 0900 Registration     0900 – 0920 Keynote Address Tan Sri Datuk Dr. Hj. Mohd. Ismail Merican Director General, Ministry of Health   Chairperson: Dr. Sulaikah Moideen Ministry of Health     0920 – 0940 OECD’s Environment, Health and Safety Programme Dr Dian Turnheim Download II. Mutual Acceptance of Data 0940 – 1010 OECD Council Decisions related to MAD Dr Dian Turnheim Download 1010 – 1040 Scope and Application of MAD and its instruments:The regulatory context Ms Katariina Rautalahti Download 1040 – 1100 Coffee Break     1100 – 1120 Scope and Application of MAD and its instruments: The GxPs (GLP, GCP, GMP) in the chemicals management framework Ms Katariina Rautalahti Download 1120 – 1140 Scope and Application of MAD and its instruments: Why GLP instead of ISO standards? Ms Louise Calder Download III. The OECD Principles of GLP 1140 – 1210 History and Development of the Principles of GLP Ms Francisca Liem Download 1210 -1300 Discussion / Q&A     1300- 1400 Lunch     III. The OECD Principles of GLP - continuation Chairperson: Mr. Razif Abd Aziz Malaysian Biotechnology Corporation     1400 – 1430 Overview of the OECD Principles of GLP Mr Hedwig Beernaert Download 1430 – 1450 Discussion / Q&A     1450 – 1510 Coffee Break      IV. GLP Compliance Monitoring 1510 – 1540 Overview of the OECD guidance for national compliance monitoring programmes – including the GLP inspection process Mr Hedwig Beernaert Download V. Specific Aspects of the Principles of GLP and Compliance Monitoring 1540 – 1550 Study Director and Sponsor Ms Louise Calder Download 1550 – 1600 Quality Assurance Mr Hedwig Beernaert Download 1600 – 1610 Field Studies Ms Francisca Liem Download 1610 – 1630 Short Term Studies Ms Francisca Liem Download 1630 - 1640 Archiving Ms Katariina Rautalahti Download 1640 – 1650 Computerised Systems Mr Hedwig Beernaert Download 1650 – 1700 Multi-site Studies Ms Louise Calder Download 1700 – 1730 Discussion / Q&A     Wednesday, 5 December 2007 Time Agenda Speaker Presentation slides VI. International Aspects of GLP Compliance Monitoring Chairperson: Prof. Dato’ Dr. Mohamed Isa Abd. Majid Ministry of Science, Technology and Innovation     0900 – 0920 International aspects and liaison among monitoring authorities, including the programme of on-site evaluation visits Dr Dian Turnheim Download 0920 – 0930 Inspecting studies abroad Ms Louise Calder Download 0930 – 0950 The Mutual Joint Visits Programme experience Mr Hedwig Beernaert Download 0950 - 1010 Adherence of non-member economies to the Council Decisions related to MAD Dr Dian Turnheim Download 1010 – 1030 Discussion / Q&A     1030 – 1050 Coffee Break     VII. Implementation of the OECD System 1050 – 1105 The perspective of the chemicals industry in OECD Ms Francisca Liem for Mr David Long Download 1105 – 1125 The perspective of governments- Implementation in the European Union Ms Katariina Rautalahti Download 1125 – 1145 The perspective of governments- Implementation in the United States Ms Francisca Liem Download 1145 - 1205 The perspective of governments- Implementation in Australia Ms Louise Calder Download 1205 – 1300 Discussion / Q&A     1300 – 1400 Lunch     VIII. Next Steps for Malaysia Chairperson: Mr. Razif Abd Aziz Malaysian Biotechnology Corporation     1400 – 1430 Malaysia’s Data Acceptance Systems- Overview Prof Dato’ Dr Mohamed Isa Abdul Majid/ Prof Dr V. Navaratnam Download 1430 – 1445 Malaysia’s Planning for GLP Prof Dato’ Dr Mohamed Isa Abdul Majid/Prof Dr V. Navaratnam Download 1445 – 1500 Coffee Break     1500 – 1600 Discussion / Q&A OECD and Malaysia Faculties   1600 Close of Meeting

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