To learn the role and scope of regulatory authorities, their requirements, applicable ICH guidelines etc.
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: Introduction to Drug Regulatory Affairs (Evolution, Roles and Responsibilities and Scope)
Module 2: Regulatory Authorities – USFDA, Canadian, EU, CDSCO, ICH, WHO
Module 3: Regulatory Requirements in Pharmaceutical (Drug Product Lifecycle – Development, Regulatory Submission, Regulatory Compliance etc.)
Module 4: Medical Device Regulation – Definition and Classification, Steps in Development, Product Lifecycle
Module 5: Overview of ICH Guidelines (Stability Testing of New Drug Substances and Products, Stability Testing : Photostability Testing of New Drug Substances and Products.
Stability Testing for New Dosage Forms, Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products, Evaluation of Stability Data, Stability Data Package for Registration Applications in Climatic Zones III and IV, Analytical Validation, Impurities Guidelines, Specifications Guidelines, Good Manufacturing practice Guidelines)
Assessment through Online Exam
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Multiple choice Online examination: 50 Questions in 40 Minutes.
Minimum 70% Marks need to Complete this Online Test
Length: 4 weeks
Timings: Self Paced
Effort: 55 hrs. approx
Skill Level: All