(28 Ratings)

Regulatory Affairs

Categories: Pharma IT
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About Course

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.

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Course Content

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

Student Ratings & Reviews

Total 28 Ratings
28 Ratings
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3 years ago
Ikya provides excellent training,friendly faculty,good content,the way of teaching is so understandable,thank you ikya.
3 years ago
I highly recommend ikya . These trainers have great level of knowledge and can clearly explain every topic
3 years ago
I'm definitely going to continue with ikya Global . It's amazing one
3 years ago
Ikya global has the best training and amazing service.I had enrolled in it. Ikya team is so polite and friendly in nature
3 years ago
It provides you with the great study environment and they explains in a fantastic manner . It's a certification course
3 years ago
Had great experience in Ikya Global
3 years ago
Good selection for training
3 years ago
Good quality training and provide good material thankyou Ikya
3 years ago
Best training and placement support at Ikya
3 years ago
Provided in depth knowledge about topics and visualised practically
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