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Inside Cliniminds


Our Pharmacovigilance Training
Partner

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

vaishnavi rathor
Stars Hi.. I am Vaishnavi I have done m.sc microbiology recently i have joined clinical research and clinical data management course in Cliniminds and got placed in an MNC as a CRC. ...more

Atul bishnoi
Stars I have done B. Pharma and after completion of graduation. I went to cliniminds for PG diploma in Clinical research and Pharmacovigilance. ...more

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Dr. Subodh Bhardwaj
MD (Pharmacology) - Director of Health Sciences Education & Training
A innovative Medical Doctor with post - graduation in Pharmacology and more than 30+ years of experience in
Clinical Medicine, Clinical Research, Pharmacovigilance and Drug Regulatory Affairs.Read More...
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