InstructorRoyed Training
TypeOnline Course
Price$90 USD / 4750 INR
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pharmaceutical regulatory affairs orientation course


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drug regulatory affairs course

This pharmaceutical regulatory affairs short orientation course provides fundamental understanding of regulation and approval of the pharmaceuticals. The course briefs how the pharmaceuticals are discovered and developed and commercialized.

The Regulatory Affairs department is an important part of the organisational structure of pharmaceutical companies. Internally it liaises at the inter phase of drug development, manufacturing, marketing and clinical research. Externally it is the key interface between the company and the regulatory authorities. Regulatory affairs professionals are involved in product development from the beginning. Regulatory restraints and requirements need to be considered when drafting the pharmaceutical, preclinical and clinical development plan.

In this online self-paced modules, participant will be understanding about the drug development to commercialization process in detail. Stages of drug discovery and development, investigational new drug application, new drug application, handling of different phases of clinical trial, generic drug approval process, Abbreviated new drug applications will be covered in phased manner for easy understanding.

Course Code: RYD-058

Course Title: Fundamental Training in Drug Regulatory Affairs

Online micro learning course. So, course can be accessed online across anywhere 24×7.

Duration: 3 Days

Any body who wants to acquire drug regulatory affairs competency should attend the course.

Any body who wants to acquire drug regulatory affairs competency should attend the course.

Who should attend this course? 

  • This course is ideal for those who requires fundamental understanding on the drug discovery, development to commercialization process.
  • Fresher/Beginners, Those who want to make a career in drug regulatory department

Certificate will be provided at the end of the successful completion of the course

  • This course provides orientation to pharmaceutical regulatory affairs. Hence, ideal for those who want to start a career in pharmaceutical industry.
  • The course briefs step by step process for registering new drug.
  • Moreover, course also provide clear cut understanding of the generic drugs and it’s approval process.
  • Advance training on drug registration requirements for various regulatory bodies.

Career in Drug Regulatory Affairs

A career in Regulatory Affairs is very challenging, but highly rewarding. It opens up lot of opportunities for professionals. But the regulatory job covers a variety of disciplines. Regulatory professional involved involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance.

The Pharma and biopharma industry is growing at a rapid pace, but there is a rising concern over the safety and efficacy. Major objective of the regulatory department to maintain safety and efficacy of the drugs and biopharmaceutical molecules. And to maintain safety and efficacy in pharmaceutical and biopharmaceutical products, regulatory agencies like US FDA, EMA, MHRA UK, DCGI, TGA – Autrallia, NMPA – China etc. all over the world are imposing number of regulation. These regulations are evolving and changing every other day. Regulatory professionals must have thorough knowledge about the updated regulations. Sound regulatory knowledge helps them to take strategic decision effectively. This has resulted in creation of regulatory department with certified regulatory affairs professionals. And it help companies to meet these requirements with ease.

About regulatory affairs job>> Learn here

Section 1Course Introduction and Module Download
Section 2Drug Discovery and Development
Lecture 2R&D Process & Introduction to drug discovery 
Lecture 3Investigational New Drug Application (INDA)
Lecture 4New Drug Application (NDA) 
Lecture 5Basic concept and understanding of the Generic Drug 
Lecture 6Abbreviated New Drug Application (ANDA) 
Lecture 7Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 8Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 9Review on Drug Discovery and Development 
Section 3Request for Course Certificate