Course Description

Highly experienced and qualified trainers to educate you in various domains of Regulatory Affairs to ensure you are well prepared when the right Opportunity knocks your door.

PharMasters Regulatory Affairs Training

Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmasterceuticals, medical devices, energy, and banking. Regulatory Affairs also has a very specific meaning within the health care industries (pharmasterceuticals, medical devices, Biologic and functional foods). It includes Abbreviated New Drug Application (ANDA), New Drug Application (NDA), Electronic Common Technical Document (eCTD), Common Technical Document (CTD), Drug Master Files (DMF).

What is Regulatory Affairs?

Regulatory Affairs in a Pharmaceutical industry, is a profession which acts as the interface between the pharmaceutical industry and Drug Regulatory authorities across the world. It is mainly involved in the registration of the drug products in respective countries prior to their marketing.

What is Generic Drugs?

A generic drug product is the one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use.

What is CTD?

The Common Technical Document (CTD) is a set of specification for application dossier, for the registration of Medicines and designed to be used across Europe, Japan and the United States.Quality, Safety and Efficacy information is assembled in a common format through CTD.

What are the goals of Regulatory Affairs Professionals?
  • Protection of human health
  • Ensuring safety, efficacy and quality of drugs
  • Ensuring appropriateness and accuracy of product information
  • Modules
  • Introduction to Global Regulatory Authorities for Pharma and Healthcare Industries.
  • Drug Development Process, Clinical Trials, Related Norms and Regulations.
  • GMP and other good practices.
  • Documentation of drug trials and regulatory filings in US, Europe, UK,India, Japan, Canada,      Australia, South Africa, etc.
  • Quality Assurance and Drug Regulations, ICH and WHO Guidelines.
  • Dossier preparation in CTD format, eCTD Submissions.
  • Healthcare Industry IPR, Patents, copyrights and Trademarks
  • Pharma and Healthcare products- Marketing, Import and Export Regulations
  • Compliance guidelines, Govt. Audits (FDA, MHRA, PMDA, TGA, DCG,etc) and Breach      Reports.
  • Industry specific case studies.
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