Diploma in Regulatory Affairs 

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Objective

The purpose of this course is to equip students with the regulations and submissions in the Life Sciences industry.

Course Overview 

Pharmaceutical industry today is measured,  and publicized as never before by the regulatory agencies all over the world. An increasingly educated public expects to receive nothing less than best quality medicines and it must be the vision and mission of every Pharmaceutical industry to deliver the excellence.
Understanding of regulations, guidelines, and submissions of the respective country is the process of continually evaluating the existing processes with the industry and developing new standards of practice has to be a core competency for every Pharmaceutical Technocrat at every level of the organization, be there in production, quality control, quality assurance, and development, regulatory affairs etc.


Learning Objective 

The Diploma course in Regulatory Affairs is designed to provide participants with a solid foundation of all the core elements of regulatory affairs. This course provides comprehensive coverage of the fundamental concepts, international guidelines, structure of common technical documentations and electronic submissions through which quality submissions and improvement can be delivered in the Pharmaceutical Industry. 


Course Content 

  • Orientation to the pharma industry 
  • Introduction to pharma regulatory affairs 
  • International guidelines on drug quality, safety & efficacy 
  • Preparation of Common Technical Document (CTD) 
  • Drug registration in regulated markets 
  • Electronic Common Technical Document (eCTD) submission through software PharmaReady.

Admission Criteria

Students from following disciplines are eligible to apply 

  • Bachelor’s Degree in Biochemistry, Chemistry, Biotechnology 
  • Master’s or Post Graduate Degree in Biochemistry
  • B.Pharm and M.Pharm 

 

Course Duration 

  • 3 months contact program 

 

Course Fee 
Please contact the counsellor @ +91 8144808255 


Course Highlights: 

  • Course material developed by experienced specialists from the Pharma Industry 
  • Highly effective one to one interactive training 
  • Flexible timings 

Course Delivery 

  • Our unique study approach enables you to balance your busy work schedule
  • Support in the form of books and articles 
  • Videos and presentations for easy understanding 

Certification 
The student is required to complete all internal assessment tests. Exam will be conducted at the end of the course. Successful candidates will be awarded Certificate by TALL.


Who should join? 

This diploma program in Regulatory Affairs is specially tailored for candidates who would like to enter into the pharma industry’s departments which include: 

  • Product development research 
  • Quality Control
  • Quality Assurance
  • Packaging and Labeling 
  • Regulatory Affairs 
  • Other relevant departments