Auriga Research

Leading Indian CRO

  • Home
    • About Us
    • Arbro Group
  • Testing Services
    • Pharmaceutical Testing
    • Food Testing
    • Herbal Testing
    • Cosmetics Testing
    • Medical Device Testing
    • Water Testing
    • Sensory Analysis
    • Inspection & Sampling
    • Construction & Building Material Testing Lab
    • Shelf Life Studies
    • Analytical Research
      • Characterization
      • Method Development
      • Method Validation
      • Stability studies
      • Impurity Profiling
      • Routine Analysis
  • Clinical Trials
    • Clinical Trial Regulation in India: Recent Updates
    • Feasibility Studies
    • Cosmetic Clinical Trial
    • Medical Writing
    • Investigator Selection
    • Project Management
    • Site Management
    • Monitoring
    • Clinical Trial Formulation
      • Clinical Trial Services (Phase I to IV)
    • Laboratory Services
      • Accomplishments
  • Bioequivalence Studies
    • Bioavailability & Bioequivalences Studies
    • Bioanalytical Methods
    • Clinical Facilities
    • Project Management
    • Medical Writing
    • Regulatory Assistance
    • Biowaiver Monograph
    • RLD Sourcing
    • Volunteers with us
  • Certification Divison
    • Overview
    • Services
      • QCI Scheme for India HACCP and India GHP
      • FSMS/ISO 22000:2018
    • Quality Policy
    • Complaint Redressal
      • Procedures – IndiaGHP & IndiaHACCP
      • FSMS/ISO 22000:2018
  • COVID 19 Testing
  • Free E-courses
    • Ethics Committee Accreditation and Registration in India
    • Analytical Training
    • Free E-Course on Bio-Equivalence Studies
    • New Drug Approval in India: A free online course
    • Free e-Course : Regulation on Medical Devices and Diagnostic Kits in India
  • Contact Us
    • Current Openings
    • Business Queries
    • Investigator Registration
    • Partnering With Us
  • News
    • Workshops
    • Conference on Challenges in Design and Conduct of Clinical Trials of Medical Devices
You are here: Home / Uncategorized / Conference on Accreditation of Sites, Investigators and Ethics Committees

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

Share this:

  • Click to share on LinkedIn (Opens in new window)
  • Click to share on Facebook (Opens in new window)
  • Click to share on Twitter (Opens in new window)
  • Click to share on Reddit (Opens in new window)
  • Click to email this to a friend (Opens in new window)
  • Click to print (Opens in new window)

Related

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Quick Query

    News

    • Commencement of new Analytical laboratory
    • Oryzanol Testing in Mustard Oil Using HPLC Method- Enforcement by FSSAI
    • CIIE, Shanghai, China (5th-10th November 2019) Booth No M5, at Hall 7.1 H
    • Ethics Committee Accreditation and Registration in India: Introduction
    • DTAB recommends not using vegetarian indicator on cellulose capsules and prohibits use of PET bottles for packaging pharmaceutical drugs
    • A report by AIIH&PH on the use of PET or plastic bottles for packaging of pharmaceutical preparations, soft drinks and alcohol
    • Arbro Pharma & Auriga Research Exhibiting in ASIA LABEX 2015
    • Conference on Challenges in Design and Conduct of Clinical Trials of Medical Devices
    • Great News! Auriga BE Center is now approved by NPCB, Malaysia
    • Conference on Accreditation of Sites, Investigators and Ethics Committees

    Tag Cloud

    Analytical testing lab Approved Drugs Clinical Research Compensation Dcgi Drug Approved Drug List Fdcs Fixed Dose Combination Informed Consent Process Mustard oil testing Not Approved Pharmaceutical testing Webinar

    Socialize with us!

    • Facebook
    • Google+
    • LinkedIn
    • Twitter

    Signup for our mailing list!






    Contact Us!

    Auriga Research Pvt. Ltd. (A Contract Research Organization)
    3/15 Kirti Nagar Industrial Area
    New Delhi
    India 110015
    e-mail - [email protected]
    Telephone - +91 11 45754546

    Copyright © 2021 Auriga Research Pvt. Ltd.

    loading Cancel
    Post was not sent - check your email addresses!
    Email check failed, please try again
    Sorry, your blog cannot share posts by email.