Regulatory affairs professionals are in high demand and the career opportunities in this area are phenomenal. This program will provide you a thorough understanding of various regulatory agencies such as the US FDA, EMA, CDSCO; investigational and new drug applications; regulatory strategies and various other concepts. Pharmaceutical industry, being one of the highly synchronized industries, is in immense need of people than ever before who are capable of managing issues related to regulatory affairs in wide-ranging manner.Regulatory affairs professionals play an important role in ensuring all pharmaceutical products comply with regulations overriding the industry. Regulatory professionals are employed in industry and are dealed with a wide range of products including pharmaceuticals, medical devices, in vitro diagnostics, biotechnology, nutritional products, cosmetics and veterinary products. The Regulatory Affairs program provides professionals with the focused knowledge required to help biotechnology, medical device, pharmaceutical and food companies manage regulatory processes. The Regulatory Affairs Training provided by RESOLVE MEDICODE would make possible the participants with the understanding of the areas of regulatory affairs and quality operations to give students a thorough and up-to-date knowledge of federal laws and regulations as they apply to all stages of the improvement and commercialization of pharmaceutical, biopharmaceutical and medical device products. At the conclusion of program participants will be provided appropriate placement assistance.
ELIGIBLITY
- Any degree in Bioscience/Life Sciences such as Biochemistry, Microbiology, Genetics, Biotechnology, Botany, Zoology etc
- Any degree in Medicine such as MBBS, BDS, BPT, BAMS, BHMS, BUMS etc
- Any degree in B.Pharmacy/ M. Pharmacy / Pharmaceutical Sciences
- Any degree in Chemistry / Biostatistics / Bioinformatics
- Any degree in Nursing / Allied Health.
- Students in their final year of graduation for the above courses are also eligible to apply.
- Any Science Graduate
COURSE MODULES
- Module 1- Pharma Regulation Practices and Procedure
- Module 2- Pharma Patents, IPR and Regulation
- Module 3- Pharma Regulatory organization in USA, EU and India
- Module 4- Clinical Trials & Regulation
- Module 5- Good industrialized Practices, Quality Assurance and Regulation
- Module 6- Regulatory Compliance for Pharma and Biotechnology Products
- Module 7- Research Study
COURSE OBJECTIVES
The program equips students with the perceptive of the regulatory processes involved in biotechnology, medical device, pharmaceutical and food products at national and international level. This specific knowledge enables regulatory affair professionals to help biotechnology, medical device, pharmaceutical and food companies supervise the regulatory processes. The students after completion of the Training will work as
- Pharma Regulatory Affairs Consultant
- Regulatory Officer