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Drug Regulatory Affairs (DRA)
DRA professionals are the connecting link between the concerned regulatory bodies and the pharmaceutical industries. PRI molds the students towards professional areas which directly belong to competitive markets in the field of drug regulatory at the global level to fit automatically into the required position easily.
Topic covered in Drug Regulatory Affairs (DRA)
• Introduction to DRA
• Introduction to DRA documentation
• Governing regulatory authorities across the globe
• The WHO-ICH guidelines
• Detailed Study of Drug & Cosmetic Act & Rule, 1940, India. Rules in USA & EU
• Detailed Study of Drug & Cosmetic Act & Rule, 1940, India & USA, EMA
• Drug registration / Licenses & documents
• Dossiers in detail
• Manufacturing & other Licenses
• Skill development training
• Familiarization to different Licenses/Forms
• Hands on practical training – Month 1st
• Hands on practical training – Month 2nd
- Three months offline /online course in Drug Regulatory Affairs (DRA)
- One month offline/online course in Drug Regulatory Affairs (DRA)
(Placement assistance, Study Material, Resume Designing, Mock Interview Practice)
- Pharma Candidates B.Pharm/ M.Pharm/ Pharm.D
- M.Sc./ B.Sc (Life Sciences)- Graduate and Post-graduate in: Biological sciences (microbiology, biotechnology, biochemistry)
- MBBS/ BDS/ BAMS/ BHMS -Candidates with graduate/ post-graduate qualifications in: Medical and allied fields like dentistry, homeopathy, Ayurveda and veterinary science, and pharmacy.
- Engineering Graduates (B.E, B.Tech, M.Tech in Biotech)
- Experience of working in the health/ pharmaceutical sector.
- Candidates currently engaged in clinical research and related operations such as: Members of institutional ethics committees, faculty members and scientists in medical colleges/ institutions and officials engaged in Clinical Research.
The students will take up Weekly/monthly tests at the end of each module. On successful completion of the final examination. Our faculties will evaluate the student on the technical and vertical skills, and provide feedback to the course coordinator, followed by training participation certification.
DURATION
- Three months offline /online course in Drug Regulatory Affairs (DRA)
- One month offline/online course in Drug Regulatory Affairs (DRA)
(Placement assistance, Study Material, Resume Designing, Mock Interview Practice)
TEST
The students will take up Weekly/monthly tests at the end of each module. On successful completion of the final examination. Our faculties will evaluate the student on the technical and vertical skills, and provide feedback to the course coordinator, followed by training participation certification.
ELIGIBILITY
- Pharma Candidates B.Pharm/ M.Pharm/ Pharm.D
- M.Sc./ B.Sc (Life Sciences)- Graduate and Post-graduate in: Biological sciences (microbiology, biotechnology, biochemistry)
- MBBS/ BDS/ BAMS/ BHMS -Candidates with graduate/ post-graduate qualifications in: Medical and allied fields like dentistry, homeopathy, Ayurveda and veterinary science, and pharmacy.
- Engineering Graduates (B.E, B.Tech, M.Tech in Biotech)
- Experience of working in the health/ pharmaceutical sector.
- Candidates currently engaged in clinical research and related operations such as: Members of institutional ethics committees, faculty members and scientists in medical colleges/ institutions and officials engaged in Clinical Research.
CERTIFICATE
