Workshop on advanced GCP training & Recent updates on regulatory requirements

GCP-1The workshop was organized jointly by Institutional Ethics Committee (IEC), D.Y. Patil University School of Medicine, Dept. of Pharmacology and Wockhardt Ltd., Mumbai, and supported by Parshwa Life Sciences Pvt. Ltd., Mumbai
The activity was conducted on 03/06/2019 in “PUSHPANJALI” auditorium of Dr. D. Y. Patil University School of Medicine & Hospital, Navi-Mumbai from 09:00 AM to 2.00 PM.

GCP-8

 

A total of 102 participants were there which included five faculty (four from Wockhardt and one from Terna Medical College, Navi Mumbai). All members of the IEC for Clinical Trials & BA/BE and IEC for Biomedical Research activity participated in the activity.

  • Dr Surekha Patil Dean, DYPSOM, Navi-Mumbai has inaugurated the programme with well come address.

  • Dr Vaishali Thakare, Associate professor & Member secretary, IEC for Biomedical Research compered the workshop.

  • Dr Deepak Langade, Professor & Head & Member secretary of IEC for Clinical Trials & BA/BE concluded the workshop with a vote of thanks.

  • Dr Devang Parikh, medical monitor, clinical operations with Wockhardt Ltd Mumbai has conducted the sessions on “Principles of GCP” & “Reporting of the SAEs”.

  • Mr. Anand Vasam, Head quality assurance auditor clinical operations, medical affairs at Wockhardt ltd. Mumbai has taken the sessions on “ ICH GCP Informed consent document & Indian scenario” & “Essential documents – A site audit perspective”.

  • Dr. Dyanesh Belekar, consultant gastrointestinal surgeon & chairman, IEC for Clinical Trials deliberated on the “Roles & responsibilities of IEC”.

  • Mrs Seema Bhagat, Manager, Medical affairs, Wockhardt Ltd. at Mumbai has taken session on “Roles and responsibilities of the Investigator & Sponsor”.

  • The last session of the program was interactive case studies conducted by Wockhardt team along with discussions.