Advanced Certification Course

in Clinical Research & Regulatory Affairs

This 6-month online, live mentorship-based program is tailored for individuals who aspire to build a strong career in Clinical Research along with a deep understanding of Regulatory Affairs — one of the most crucial departments in the pharma and biotech industry. The program bridges the academic–industry gap and prepares you for global regulatory expectations and documentation standards required for product approvals and compliance.

🔬 Clinical Research Modules

✔️ Drug Development Lifecycle & Clinical Trial Phases (I–IV)
✔️ Global Clinical Guidelines: ICH-GCP, Indian GCP, FDA, EMA
✔️ Protocol Design, Ethics Committees & Site Selection
✔️ Clinical Trial Documents: IB, ICF, CRF, TMF
✔️ Trial Execution, Monitoring & AE/SAE Reporting
✔️ Compliance Management, Audits & SOPs

📑 Regulatory Affairs Modules

✔️ Overview of Regulatory Affairs & Global Health Authorities
✔️ Drug Approval Process: India (CDSCO), US (FDA), EU (EMA)
✔️ Dossier Compilation: CTD, eCTD Format
✔️ IND, NDA, ANDA, DMF Filing Process
✔️ Regulatory Submission Pathways
✔️ Labeling, Advertising, and Packaging Requirements
✔️ Regulatory Intelligence & Change Management
✔️ Post-Marketing Compliance & Pharmacovigilance Interface

🧾 Program Details

📅 Duration

6 Months

🌐 Mode

100% Online (Live Interactive)

👨‍🏫 Mentors

Industry Regulatory Experts

👥 Batch Size: Small Groups | 🎓 Eligibility: B.Pharm, M.Pharm, Pharm.D, BSc, MSc, MBBS, BDS, BHMS, BAMS, Biotech & Lifesciences Graduates

🏆 What You Get

📜 Dual Certification 🧪 Internship 📘 Resume & LinkedIn Training 🧑‍💼 Mock Interviews 💼 100% Placement 📊 Dossier Examples

🎯 Career Opportunities

Eligible roles after successful completion:

Regulatory Affairs Associate Regulatory Executive Clinical Trial Regulatory Coordinator Clinical Research Coordinator Clinical Trial Assistant Dossier Submission Specialist Labeling Executive

📞 Still Have Questions?

WhatsApp/Call: +91 9370472071 | +91 8999213129

Email: clinideaeducation@gmail.com

Website: www.clinidea.in

LinkedIn: Clinidea Education

✅ Enroll Now 📄 Download Brochure Fees Details

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