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Inside Cliniminds


Our Pharmacovigilance Training
Partner
think-i

NABH EC Accreditation Services

As per recent guidelines as put forth by DCGI (see attached office order) accreditation of Ethics Committees is a mandatory step. Shortly, this will become a 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.

NEED: 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, an adequate focused attention as well as professional support is recommended.

Description of Services

STEP I: ORIENTATION

Objective: To orient Ethics Committee on NABH Accreditation requirement, role and responsibilities of ECs and guide them through the application process

Module covered will be of half day duration workshop encompassing:

  1. Latest updates on Indian regulatory requirements as well as GCP
  2. Roles of EC members in detail
  3. Learning from NABH Audit
  4. NABH accreditation requirements - Site/Investigator/Ethics Committee- Important do's and don'ts and application requirements.
STEP II: PROCESS GAP ANLYSIS AND APPLICATION SUBMISSION SUPPORT

Objective: To internally review documentation and processes of Ethics Committee. Identify Gap analysis and work to close Corrective and Preventive action (CAPA)

Duration: Ethics Committee Audit: Half day workshop

Scope of work:

  • Review of existing EC SOPs and conducting gap analysis
  • Detailed audit report to management with recommended Corrective Action and Preventive Action (CAPA).
  • Complete support to sites until successful adoption of CAPA.
  • Complete support to sites for submission of successful application to NABH

For more information, please call at +91 98100 68241 or info@cliniminds.com
+91-9910068241
+91-9560102589
+91-9810068241
Google Reviews

Dibakar Mazumder
Stars Myself Dibakar Mazumder. Student id-5563. I have done Masters in biotechnology. I had enrolled in advanced postgraduate diploma in Clinical research, clinical data management, and pharmacovigilance from Cliniminds. ...more

Aashna Sharma
Stars If you are thinking to build your career in Pharmacovigilance and Clinical research, CLINIMINDS is the best option. The staff here is so cooperative and will help you build a great level of confidence, not only professionally but also personally. You will come out as an improved version of yourself. They put their 100% effort to get all of their students placed in good companies. ...more

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Dr. Sandeep Bhatia
Medical Director & Senior Partner – Healthcare & Life Sciences
Dr. Sandeep Bhatia is Medical Affairs & Clinical Development leader with 15 years of Pharmaceutical and clinical research experience. Dr.Sandeep Bhatia
Dr Sandeep has worked extensively in field of Oncology Medical Affairs and headed Medical Affairs department for Global Pharmaceutical companies. He was the Head of Oncology Medical Affairs for MSD India and also led Medical Affairs team for Roche, India. Apart from this he has gained significant experience by working in companies like Novartis , Sanofi & Mylan.Read More...
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