The Chairperson Ethics Committee/IRB Dear Sir/Madam, WORKSHOP ON NABH - - PDF document

The Chairperson Ethics Committee/IRB Dear Sir/Madam, WORKSHOP ON NABH ACCREDITATION OF ETHICS COMMITTEES ON SATURDAY 5th MAY 2018 ‐ MUMBAI Greetings form Cliniminds. After successful workshop in Delhi on 10th March, we are pleased to inform you that we are organizing one day workshop

• n “NABH Accreditation of Ethics Committee” on 5th MAY 2018 at Mumbai.

Cliniminds has conducted over 100 GCP workshops and worked with several ECs across India. Certificate of Participation would be awarded to all participants. As per recent guidelines as put forth by DCGI (see attached office order) accreditation of Ethics Committees is a mandatory step. There are around 1300 registered independent and institutional ethics committees in India. Accreditation of Ethics Committees involved in supervision of clinical trials is mandatory with effect from 01.01.2018. This has become a one of the deciding factor for DCGI to recognize and accept site/EC/investigator for conducting clinical trials in India. Thus, there is an immediate need to get ready and start the application process. Majority of ECs have been subjected to NABH inspection and from the overall outcome so far, it is evident that thorough preparedness of EC members to face inspectors and address queries is lacking. Therefore, in order to be well prepared and pass the inspections in first go, we have organized this workshop to provide knowledge, an adequate focused attention as well as professional support. Speakers and experts from Industry will be emphasizing & discussing following topics:‐ 1. GCP Refresher 2. Latest updates on Indian regulatory requirements as well as GCP 3. Schedule Y and Recent Regulatory Updates, including Patient Compensation 4. Roles of EC members in detail 5. Handling NABH Audit 6. NABH accreditation requirements‐ Site/Investigator/Ethics Committee 7. Important do's and don'ts and application requirements. 8. Required Documentation and SOPs of Ethics Committee Speakers: Senior, experienced trainers would manage the workshop. Key trainer would be Ms. Deepti Goel from Cliniminds, along with other speakers. Fee: Rs. 6, 000/‐ plus 18% GST. Fee includes, workshop folder, certificate of participation and lunch. Date: Saturday, 5th May – from 9.30 to 5.00 p.m. Limited Seats. Tentative Venue: Cliniminds Mumbai C/o Nucleon Therapeutics LLP, 105‐ Ackruti Star, MIDC Andheri East, Mumbai‐ 400093, India – M: 08527298240 Fee Payment: By cheque, draft in favour of ‘Tenet Health Edutech Pvt. Ltd.’ or credit card. Looking forward for participation from your Ethics Committee. Thanks and best regards, Rahul Malia Head Corporate Marketing Mobile No‐ 8527298240, Email Id‐ rmalia@cliniminds.com

Workshop Registration Form WORKSHOP ON NABH ACCREDITATION OF ETHICS COMMITTEES

NOIDA – 5th May 2018 – Saturday

Name: Mr./Ms./Mrs./Prof./Dr.

(Tick Appropriate) (First Name) (Last Name)

Company Name: Designation: Company Address: City: State: Country: Pin: Phone (Off.)1: Phone (Off.)2: Mobile: E-mail (official): E-mail (Personal):

Fee Details: Cash Cheque / Draft No. Date: Bank: Other:

Where did you hear about this Workshop

Internet Friends Advertisement Industry Referral Cliniminds Promotion Date: Place: (Signature)

CLINIMINDS Tenet Health Edutech Pvt. Ltd.

C-101, First Floor, Sector-2, Noida-201301 Contact No. :+91 8527298240 E-mail: rmalia@cliniminds.com, Website: www.cliniminds.com