Conference on Accreditation of Sites, Investigators and Ethics Committees

Conference on Accreditation of Sites, Investigators and Ethics Committees – 17th Apr 2015

Workshop on Causality Assessment for Clinical Trials in the Indian Scenario – 18th Apr 2015

Venue – Hotel Royal Orchid Central, Gurgaon

Timing – 9:00 am to 5:00 pm (Both the days)

In the last 3 years, the Clinical Research industry of India has witnessed some major regulatory changes which have drastically affected the functioning for all stakeholders.

The latest development has been the requirement for accreditation of Sites, Investigators and Ethics Committees. Very recently on 03rd Mar 2015, CDSCO office has released the draft standards for accreditation of Sites, Investigators and Ethics Committees, alongwith the application format. Source:http://www.cdsco.nic.in/forms/list.aspx lid=2074&Id=23). There are many aspects within these standards which need further discussion, understanding, and training. Keeping this in view, we have come up with a conference on ‘Accreditation Standards for Sites, investigators and Ethics Committees’. (Details captured below).

Further, although it has been 2 years since Rule 122 DAB was released, there still exists great confusion about the causality assessment and relatedness of the injury to the Clinical Trial among various stakeholders. We have thus organized a workshop on ‘Causality Assessment for Clinical Trials in the Indian Scenario’ to empower the stakeholders to use various tools available and also to handle different situations which come their way while dealing with causality assessment. (Details captured below).

SenseCR & Auriga Research Ltd. have once again collaborated to meet the training needs of the Clinical Research industry and have come up with training programs on topics of need of the hour.

Some our esteemed faculty for the Conference and Workshop:

• Chief Guest: Dr. Y K Gupta, Professor and Head, Department of Pharmacology, AIIMS
• Dr. Arun Agarwal, Chairman of expert committee to examine SAE of death in clinical trials, Professor of ENT & Dean, Maulana Azad Medical College
• Dr. Mita Nandy, Consultant, New Drugs, CDSCO
• Dr. Roli Mathur, Scientist E, ICMR
• Dr. Khalid Khan, Director, Fermish Clinical Technologies Pvt. Ltd. & Regulatory Consultant
• Dr. Rajeev Shrivastava, Associate Director, Clinical Research, Eli Lilly and Company
• Dr. Jamal Anwar, Country Head, Pharmacovigilance, Merck Sharpe & Dohme
• Shilpa Garg Agrawal, Founder & CEO , SenseCR
• Dr. Ashish Rastogi, Asst. Director, Excel Life Sciences
• Mr. Subhash Sugathan, Asst. Manager Compliance and Regulatory Affairs, Excel Life Sciences
• Rajesh Saxena, Head Clinical Research(Operations),Max Health Care
• Dr. Anupam Prakash, Associate Professor of Medicine & Member Secretary of Ethics Committee for Human Research, Lady Hardinge Medical College and Associated Hospitals
• Other faculty yet to be decided

Early Bird Discount can be availed till 31st Mar 2015

Register early to avoid disappointment, since our batches fill up soon!
Discount available for combined attendance in both the conference and workshop

Contact Mr. Nishant Singh for all registration related queries at 09540930950 or email at [email protected]

Conference on Accreditation of Sites, investigators and Ethics Committees
17th April 2015 (Friday)

Download the related documents here:
Event Flier
Agenda
Registration Form

Workshop on Causality Assessment for Clinical Trials in the Indian Scenario
18th April 2015 (Saturday)

Download the related documents here:
Event Flier
Agenda
Registration Form