Workshop on Recent Changes in the Regulatory Scenario of India with Respect to Serious Adverse Events, Compensation and Registration of Ethics Committees
Date: 10th April 2013,
Time: 9:00 am to 6:00 pm
Venue: Convention Centre, Jamia Hamdard, New Delhi
| 9:00 | 10:00 |
Registration |
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10:00
11:00
Inauguration (Honorable Guest: Dr G. N. Singh DCGI, CDSCO)
11:0011:30
Tea Break
PROGRAMME
TIME
Topic
Faculty
11.30
12.00
Regulatory challenges in upcoming clinical trial process and documentationDr. Khalid Khan, Director, Fermish Clinical Technologies Pvt. Ltd. & Regulatory Consultant
12:00
12:45Changes in compensation requirements, SAE reporting timelines, Informed consent requirements, and SAE reporting processShilpa Garg Agrawal, Founder &
CEO, SenseCR
12:45
13:15
Case Studies
Shilpa Garg Agrawal, Founder &
CEO, SenseCR
13:15
14:00
Lunch Break
14:00
14:30
Pharmacovigilance reporting for Sponsors and CROs Before and after Rule 122DAB, Appendix XII
Dr. Jamal Anwar, Country Head, Pharmacovigilance, Merck Sharpe and Dohme
14:30
15:00
Rule 122DD: Working and Registration of Ethics Committees
Dr. Manoj Karwa, Head, Project Planning and Management, Auriga Research Ltd.
15:00
15:30
Ethics Committees functioning as per current regulatory requirements of India
Dr. Roop Khar, Chairman, Good Society for Ethical Research
15:30
16:00
Tea Break
16:00
16:30
Are the clinical trial insurance and indemnity policies affected by amended regulations
Dr. Banusri Velpandian, Advocate
16:30
17:00
How do the amended regulations affect the conduct of Vaccine Clinical Trials
Dr. Shilpi Jain, Senior Manager- Clinical Trial, Panacea Biotec Ltd
17:00
17:30
Impact of the amendments on research related to traditional system of medicine
Prof. M.A. Jafri, former Director, National Institute of Unani Medicine, Faculty of Medicine (Unani), Jamia Hamdard
17:30
18:00
Valedictory Function