Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines, and by the companies responsible for the discovery, testing, manufacture and marketing of these products wanting to ensure that they supply products that are safe and make a worthwhile contribution to public health and welfare. A new class of professionals emerged to handle these regulatory matters for companies.
Regulatory professionals are responsible for:
Keeping track of the ever-changing legislation in all the regions in which a company wishes to distribute its products
Advising on legal and scientific restraints and requirements
Collecting, collating and evaluating scientific data
Presenting registration documents to regulatory agencies and carrying out any subsequent negotiations necessary to obtain or maintain marketing authorisation for the products concerned
Giving strategic and technical advice at the highest level in their companies, making an important contribution both commercially and scientifically to the success of a development programme and the company as a whole
Helping the company avoid problems caused by badly kept records, inappropriate scientific thinking or poor presentation of data.
Topics for this course
Introduction to Global Regulatory and Authorities of pharma and healthcare industries
Pharmaceutical Development Process (QbD & Qbt), Clinical Trials and related rules and regulations.
GMP for Quality, Safety and Efficacy
Quality Assurance and Drug Regulations, ICH, WHO, D&C guidelines
Product registration documentation through NDA, ANDAs in CTD format& submissions
Pharma and healthcare products packaging material regulations
Healthcare Industry IPR, Patents, copyrights and Trademarks
Pharma and Healthcare products Marketing, Import and Export regulations
18Agencies audits (USFDA, UKMHRA, PIC/s, TGA, CDSCO, Local DCA , etc) and warning reports
Practical knowledge in dossier preparation and filing in CTD and DMF modals
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