Good Clinical Practice (GCP) Workshop@IGMPI

(MODE: Online/Regular)

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:

• Various pharmaceutical/ biotech and clinical research organizations recommend GCP certification to their employees
• Organizations are hiring professionals certified in GCP for planning and conducting GCP audits (vendor, internal process and investigator site) and may include responsibilities for providing Quality Assurance support to clinical operations.
• Good clinical Practice (GCP) training is important for organizations in the business of clinical research so that they can comply with the industry guidelines, and regulations. 

Objectives:

• To impart foundational and advanced knowledge on GCP principles.
• To develop competence in conducting ethical and compliant clinical trials.
• To align participants with current regulatory standards (CDSCO, US FDA, EMA, MHRA).
• To prepare professionals for audits and inspections.

Key Highlights:

• Live Interactive Sessions by industry experts
• Case Study-Based Learning & practical scenarios
• Digital GCP Toolkit (templates, protocol, consent forms, case report form)
• Participation Certificate
• Networking Opportunities with industry professionals 

Target Audience:

• Clinical Research Associates (CRA) & Coordinators
• Pharmacovigilance and Regulatory Affairs Professionals
• Physicians and Site Investigators
• Medical, Pharmacy, Life Science Students & Graduates
• Quality Assurance & Compliance Officers 

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
4. Essential Documents:
1. Informed Consent
2. Protocol
3. Investigator’s Brochure
5. SAE Reporting
6. Audit & Inspection
7. Investigational Product – Accountability
8. Consequences of GCP non-compliance
9. Case Studies Discussion- Integrating GCP principles in Clinical Research Conduct
10. Difference between Indian GCP and ICH GCP
11. Questions and & Answers session 

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.

Workshop Duration:

• 2 Days (Weekend Batch)
• Available in both On-Campus & Online Mode

Certification

All participants will receive a Certificate of Participation from IGMPI. This certificate is widely recognized across the pharmaceutical, biotechnology, and clinical research industries.

For further enquiries, call or write to us on:
18001031071 (Toll Free -9:00 am to 5:30 pm IST-except on Central Government holidays)/ info@igmpi.ac.in