REGULATORY AFFAIR COURSES

This course is designed to provide industry level education in the field of legal and regulatory issues. These issues are very critical to pharma companies, Clinical Research Organization, Biotech companies. 
The course focuses on regulatory affairs concept that the pharmaceutical company companies should follow to sell their medicine both domestically and within the international market.

Course Objective
• To create a thorough understanding of necessary regulatory concepts
• To create experts within the field of RA documentation and analysis.
• To create an entry platform within the field of RA for recent graduates.
• To help students build their careers in RA and become RA professionals.
• To give students a world knowledge of regulatory Affairs and DCS 

   courses are one of the best regulatory affairs courses in Pune

Course Structure
• Basic Fundamentals of regulatory Affairs
• Introduction to regulatory Bodies
• Introduction to Quality Standards for regulatory Compliance
• Common Technical Documents - CTD (API & Formulation)
• Introduction to eCTD
• ASEAN Common Technical Dossier (ACTD)
• Marketing Authorization Procedures in the USA
• Marketing Authorization Procedures/ Channels in Europe
• Marketing Authorization Procedures in India
• Marketing Authorization Procedures in ROW markets
• Maintenance and Annual updates for selling authorizations
• Reference on additional reading Course period
6 Months (Classroom cum internship Program)

Learning Outcome
• Able to write regulatory Documents
• Create regulatory Strategy
• Get marketing Authorization from different countries
• Become an RA professional

Career Opportunities
A career in regulatory Affairs is both a challenging and highly rewarding career. It opens up a ton of opportunities because it covers a range of disciplines. individuals who are directly involved in the regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance, and others are considered regulatory professionals.
The pharma industry is growing at a fast pace and there's a rising concern over the safety and efficacy of pharmaceutical and medical device products. to keep up safety and effectualness in pharmaceutical company & medical device products, regulatory agencies like USA FDA, UK MHRA, EDQM, DCGI etc everywhere the planet square measure imposing no of regulation. This has resulted in the creation of a distinct department with highly qualified professionals who can help companies meet these requirements with ease..