The Diploma in Drug Regulatory Affairs offered by Pharma Research is a focused and professionally crafted online certification program that equips learners with essential knowledge of the global and Indian regulatory frameworks governing the development, approval, and marketing of pharmaceutical products. Conducted over 3 months in a flexible online format, the program covers critical areas such as drug development processes, regulatory submission requirements, dossier preparation (CTD/eCTD), regulatory guidelines (like USFDA, EMA, CDSCO), and compliance protocols for new drug approvals. This certification is ideal for graduates or final-year students in Pharmacy, Life Sciences, Biotechnology, and related fields, as well as working professionals looking to transition into regulatory affairs roles within the pharmaceutical and healthcare industries. With IACCRE accreditation, online verifiable certification, lifetime access to learning materials, and placement assistance, this program prepares candidates for roles such as Regulatory Affairs Associate, Dossier Executive, and Regulatory Compliance Specialist, making it a strategic step for those aiming to work in drug regulation and international pharmaceutical compliance.
Certification in Drug Regulatory Affairs-Drug Regulatory Affairs is the result of a government’s desire to protect public health by controlling the safety and efficacy of products in areas such as pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
The worldwide outsourcing market for regulatory affairs is expected to grow at the CAGR of 14.6 to 2040 and the industry is expected to reach $4.5B.
The Professional Certification in Drug Regulatory Affairs (PCDRA) course allows participants to acquire in-depth knowledge of the relevant global regulatory authorities and reporting requirements, regulation of medical devices, roles and responsibilities. The PCDRA course will help you to succeed in your profession as a Drug Regulatory Associate or an Executive.
Module 1 | 1 – Regulatory Considerations when filling an investigation new drug application | |
Unit 1 | Lecture regulatory Considerations When Filing An Investigation New Drug Application I-1 | |
Unit 2 | Regulatory Considerations When Filing An Investigational New Drug Application Ii-2 | |
Unit 3 | Regulatory Considerations When Filing An Investigational New Drug Application Iii-3 | |
Unit 4 | Regulatory Considerations When Filing An Investigational New Drug Application Iv-4 | |
Unit 5 | Regulatory Considerations When Filing An Investigational New Drug Application V-5 | |
Module 2 | 2. Clinical Study & Start-up Activities Part | |
Unit 1 | Clinical Study & Start-up Activities I-1 | |
Unit 2 | Clinical Study & Start-up Activities II-2 | |
Unit 3 | Clinical Study & Start-up Activities III-3 | |
Unit 4 | Clinical Study & Start-up Activities IV-4 | |
Unit 5 | Clinical Study & Start-up Activities V-5 | |
Module 3 | 3. Clinical Trials Phase 1 | |
Unit 1 | Clinical Trials Phase 1 Part I-1 | |
Unit 2 | Clinical Trials Phase 1 Part II-2 | |
Unit 3 | Clinical Trials Phase 1 Part III-3 | |
Unit 4 | Clinical Trials Phase 1 Part IV-4 | |
Unit 5 | Clinical Trials Phase 1 Part V-5 | |
Module 4 | 4 – Clinical Trials Phase 2 | |
Unit 1 | Clinical Trials Phase 2 Part I-1 | |
Unit 2 | Clinical Trials Phase 2 Part II-2 | |
Unit 3 | Clinical Trials Phase 2 Part III-3 | |
Unit 4 | Clinical Trials Phase 2 Part IV-4 | |
Unit 5 | Clinical Trials Phase 2 Part V-5 | |
Module 5 | 5 – Industry Considerations with Phase 3 Clinical Trials Part | |
Unit 1 | Industry Considerations with Phase III Clinical Trials I-1 | |
Unit 2 | Industry Considerations with Phase III Clinical Trials II-2 | |
Unit 3 | Industry Considerations with Phase III Clinical Trials III-3 | |
Unit 4 | Industry Considerations with Phase III Clinical Trials IV-4 | |
Unit 5 | Industry Considerations with Phase III Clinical Trials V-5 | |
Unit 6 | Industry Considerations with Phase III Clinical Trials V-5 | |
Module 6 | 6 – New Drug Application, Filling, Product Labeling | |
Unit 1 | Industry Considerations with Phase III Clinical Trials V-1 | |
Unit 2 | Industry Considerations with Phase III Clinical Trials V-1 | |
Unit 3 | New Drug Application, Filing, Product Labeling II1-3 | |
Unit 4 | New Drug Application, Filing, Product Labeling IV-4 | |
Unit 5 | New Drug Application, Filing, Product Labeling V-5 | |
Unit 6 | New Drug Application, Filing, Product Labeling VI-6 | |
Module 7 | Quiz- Online Test | |
Unit 1 | Quiz- Online Test |
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Student 3200
Length: 4 weeks
Timings: Self Paced
Language: English
Effort: 55 hrs. approx
Skill Level: All
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