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:
* CERTIFICATE FOR PARTICIPATION WILL BE AWARDED TO ALL THE PARTICIPANTS.
FACULTY / TRAINER PROFILE
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.
Eligibility: Pharma / Medical / Biotech / Life Sciences / Cosmetics / Homeopathy / Ayurveda / health supplements, alternate healthcare and other life sciences pass-outs and professionals.For further enquiries, write to or call us on:
Mr Vinod Arora, Principal Advisor, IGMPI
Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like