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Instructor: Mr. Ram Verma
Validity Period: Lifetime
Regulatory Affairs is a comparatively young, multidimensional and growing profession in the Pharmaceutical field with a desire to protect public health. DRA assures safety and efficacy of pharmaceuticals products, veterinary medicines, medical devices, pesticides, agrochemicals, orphan drugs, cosmetics and complementary medicines.
As outsourcing of jobs to India is high, the regulatory affairs industry in India is poised for rapid growth which is associated with flamboyant salaries. There are 120+ pharma companies having structured regulatory affairs department in India. Due to the entry of MNCs in India, it is expected a requirement of 30,000 competent and trained workforce in next 5 years.
If you are looking to start your career in Drug Regulatory Affairs or Pharma Regulatory Affairs or you are already in this industry without any formal training, the course “Certificate Program in Drug Regulatory Affairs” will certify and train you for the entry-level job positions like DRA Executive, Regulatory Affairs Associate.
The course will provide you a comprehensive training on scientific, practical, ethical and technical concepts of the drug regulatory affairs in compliance with regulatory guidelines. This 2 months course covers all the essential topics of DRA in 5 major modules covering 300+ topics. Each module is well explained in detail with the help of illustrations, examples, and flowcharts.
The course can be attended by:
Health-science professional (working/fresher/ student) from Pharmacy, Life-Science/ Biotech, Medicine, AYUSH (Alternate Medicine), Dental, Nursing, Physiotherapy, Ph.D. background who are looking to gain knowledge & start their career in the pharma or device regulatory domain.
Fresher and experienced regulatory affairs personnel.
Upcoming batch Starting from: 27th Aug
Duration: 1 Month(FRI-SAT-SUN)
Timing: 6PM-7:30 PM
All participants will get DBT recognized & NSDC approved Learntoupgrade certificate.
How to purchase the course:
Add to cart
All classes will be live interacted with the industry experienced trainer.
Industry meet curriculam only
World wide recognised certification
Missed any Class? get the recording access for the lifetime
Many publication samples will be shared
A quality industry certificate
Learn research paper writing, letter writing
Interview skills session will be deliver
Assignment and weekly test to maximize your knowledge.
Total seats: 50
Note: Fee is Dynamic, In future you can see the increase in fee .
Contact: In case any query get in touch with us on whatsapp: +91 7290079907
|Module1: Introduction to Drug regulatory affairs|
|evaluation of regulatory affairs|
|scope of professional responsibility|
|role of regulatory affairs in product|
|Development, potential regulatory positions|
|Career growth opportunities|
|Class 1: Drug Regulatory affair: 2nd Dec|
|Module2: Regulatory Authorities|
|US-FDA Organization and its Regulatory Mechanism and Document|
|Canadian Regulatory System|
|EU Regulatory Framework, CDSCO India, ICH, WHO|
|Class 2: DRA: 4th Dec|
|Module3: Regulatory Requirements in Pharmaceutical|
|Drug Product Lifecycle|
|CTD and eCTD, NDA, Regulatory Compliance Activities, GLP, GCP, GMP, Pharmacovigilance|
|Class 3: Drug Regulatory Affair: 7th Dec|
|Module 4: Medical Device Regulation|
|Definition and Classification of Medical Devices|
|Steps in Medical Device Development, Product Lifecycle)|
|Class 4: Drug Regulatory Affairs: 9th Dec|
|Module 5: Applicable ICH Guidelines in DRA|
|Q1A, Q1B, Q1C, Q1D, Q1E, Q1F, Q2, Q3, Q6, Q7|
|Class 5: Drug regulatory Affair: 11th Dec|
|Class 6: Drug Regulatory Affair: 15th Dec|
|Class 7: Drug Regulatory Affair: 16th Dec|
|Class 8: Drug Regulatory Affair: 18th Dec|
|Class 9: Drug Regulatory Affairs: 21st Dec|
|Class 10: DRA:23rd Dec|
|Class: Drug Regulatory Affairs: 2nd July|
|Assessment and Evaluation through MCQ test|
|Drug Regulatory Affairs|
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