Institute of Good Manufacturing Practices India
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WORKSHOP BY IGMPI

On

Good Clinical Practice (GCP)

(MODE: Interactive/Online learning)

www.fcrindia.org | www.igmpiindia.org


Importance of ICH-GCP Knowledge in Clinical Research

The ICH-GCP guidelines are developed to facilitate an international ethical and scientific quality standard for planning, executing, supervising, documenting, auditing, examining and reporting bio-medical and behavioural research studies concerning human population. The ICH-GCP guidelines provide platform to the industry in form of two basic standards: protecting the rights, safety and welfare of human subjects; and the genuineness of the data generated by the research.ICH-GCP guidelines confer objective to provide one single standard to facilitate the conduct of clinical trials across the US, European Union & Japan.

ICH-GCP training and certification is strongly recommended throughout the world as the guidelines are globally accepted. It is a basic acceptable standard for working as a clinical research professional. Getting Good Clinical Practice certified has multiple advantages such as:

Topics for GCP Training Workshop:

  1. Basic Introduction to ICH GCP & Overview of New Revision

  2. Principles of ICH GCP

  3. Responsibilities:

  1. Sponsor

  2. Investigator

  3. Ethics Committee

  1. Essential Documents:

  1. Informed Consent

  2. Protocol

  3. Investigator’s Brochure

  1. SAE Reporting

  2. Audit & Inspection

  3. Investigational Product – Accountability

  4. Consequences of GCP non-compliance

  5. Case Studies Discussion- Integrating GCP principles in Clinical Research Conduct

  6. Difference between Indian GCP and ICH GCP

  7. Questions and & Answers session

Details are as follows: (USD 100 for Overseas Participants)

The Payment details are available on request.

* CERTIFICATE FOR PARTICIPATION WILL BE AWARDED TO ALL THE PARTICIPANTS.

FACULTY/TRAINER PROFILE
Ms Sneha Gupta: Ms Sneha Gupta, is an experienced Clinical Trials Regulatory Manager. She has to her credit a rich experience of about ten years in core regulatory affairs, specializing in all aspects of Clinical Research. She is well-versed in modalities of ICH –GCP, Indian and Global Regulations dealing with Clinical Trials, post approval compliance and thereafter drug registration procedures.

In her role she provides strategic regulatory oversight for accurate dossier development and navigation through the regulatory review and approval cycle at the Health Authority Office to get on-time regulatory approvals. She has specialized in leading, organizing and managing all kinds of regulatory and study start-up activities for conducting various types of clinical Studies (across multiple therapeutic areas). Sneha Gupta, is Clinical Trials Regulatory Manager, for the Clinical Study Unit, Sanofi India.

She has been a valued contributor and partner in ideating some of the key ideas put out in the online submission portal for GCT applications of SUGAM at CDSCO India. She is a Biotech Engineer with a Master’s Degree in Clinical Research. Additionally she is a “Certified Trainer” for GCP, Bioethics, Clinical trials regulatory affairs and Corporate Behavior.

IGMPI is actively involved in taking various initiatives towards knowledge dissemination and training for life sciences students and professionals. Our study programmes are designed according to latest guidelines and updates and addressing all major requirements set aside by industry experts.

The workshop is ideal for professionals who wish to attain effective good clinical practice skills in compliance with applicable regulatory guidelines.

For registration form, please write to [email protected] along with your resume or profile. The agenda of the workshop will be sent to your email id.

The seats are limited and the registration for the workshop is based on 'First comes first serves basis'. However, one more batch will also be announced shortly to accommodate all participation requests.

Eligibility: Pharma / Medical / Biotech / Life Sciences / Cosmetics / Homeopathy / Ayurveda / health supplements, alternate healthcare and other life sciences pass-outs and professionals.

For further enquiries or Prospectus, write to or call us on:

[email protected]/+91 8130924488, +91 8587838177, 0120-4375280