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WHO sponsored workshop on Good Clinical Practice for Ethics Committee Members

WHO sponsored workshop on Good Clinical Practice for Ethics Committee Members. an orientation to the workshop B.Gitanjali Organizing Secretary. Why this workshop?. By 2010, clinical trials to the tune of $250-300 billion will be performed in India. 1 Schedule Y

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WHO sponsored workshop on Good Clinical Practice for Ethics Committee Members

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  1. WHO sponsored workshop onGood Clinical Practice forEthics Committee Members an orientation to the workshop B.Gitanjali Organizing Secretary

  2. Why this workshop? • By 2010, clinical trials to the tune of $250-300 billion will be performed in India.1 • Schedule Y • CDSCO, Govt. of India & WHO initiative to train all major stakeholders in GCP 1. Bhatt A. Clinical trials in India: Pangs of globalization. Indian J Pharmacol 2004;36:207-8.

  3. Why this workshop? All gave some Some gave all…

  4. Aim of the workshop • To create awareness among individuals who serve on ethics committees, on the various aspects of GCP with special emphasis on the current Indian regulations and guidelines for clinical trials. • To provide the knowledge and skills required for a member of the EC to review and monitor trials according to local and international GCP requirements and safe guard the wellbeing and interests of the trial participants.

  5. Schedule Y Ethics committees GCP Legal Issues Investigator & Sponsor Responsibilities Serious Adverse Events SOPs Special Issues Publication Issues Informed consent

  6. Objectives of the workshop • At the end of the workshop the participant shall : • Understand and apply relevant portions of GCP guidelines • Understand the procedures to be adopted for safeguarding the rights, safety and wellbeing of subjects participating in clinical trials • Understand ethical review of essential documents of a clinical trial • Be able to conduct a risk benefit assessment of the protocol prior to giving approval

  7. During the workshop • Please be on time. Sessions start at 8.30 A.M. • Do not hesitate to ask questions, voice your opinions or disagree with the resource person. • There may be more than one correct answer for a question. • Some questions may not have an answer as yet. • Try to finish the given task within the allotted time.

  8. Day 1 Reba Kanungo Dinesh Mahale S.Pradeep Day 2 Sheila Ananda Kumar Rathinam Sivakumar J.Yuvaraj Rapporteurs for the workshop

  9. Course Material • Inside your bag: • ICMR guidelines • Schedule Y • ICH guidelines • Spiral bound copy – objectives of all sessions, Helsinki Declaration, CIOMS guidelines, Belmont Report, all the group tasks, operational guidelines EC from WHO and ICMR • Before you leave – collect the CD & certificate

  10. Arrangements for the three days • Bus will pick you up from Surguru at 7.15 A.M.sharp. To take you to the JIPMER community Hall for breakfast. • Transport provided • Bus will pick participants from Guest house at 7.40 P.M. for dinner at Anandha Inn. • Dinner at 8.00 P.M. • Collect TA & DA at the community hall during lunch tomorrow

  11. Meal timings • Breakfast 07.30-08.30 hrs • Lunch 13.00-14.00 hrs • Dinner 20.00 • Refreshments during the workshop. • All meals at the JIPMER community Hall. • Inform reception desk for bed coffee/tea

  12. Wishing you an intellectually stimulating workshop

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