About Drug Regulatory Affairs
This online drug regulatory affairs course provides training on regulation, registration process and strategic planning for pharmaceuticals. This 1 week short online course trains Drug Regulatory Affairs professionals on fundamental aspects of drug discovery, development related regulations. In addition, the course provides practical knowledge. Hence, this short drug regulatory affairs short certification course helps how regulatory affairs department works in pharmaceutical company. Therefore, it helps users to understand the key responsibilities and job functions.
In this online self-paced modules, participant will be understanding about the drug development to commercialization process in detail. For example, course covers important topics like 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. Hence, this course covers comprehensive topics to develop the fundamental competency on drug regulatory affairs.
Course Code: RYD-016
Course Title: Competency Development Program in Drug Regulatory Affairs
Who should attend this course?
- Those who are in regulatory affairs and related department.
- Professionals from drug discovery development.
- Anyone requiring an overview of drug regulatory affairs.
- Fresher or Beginners. Those who want to make a career in drug regulatory department.
This is online self paced learning course. Therefore, this course is accessible 24×7 from anywhere.
7 Days / 1 Week
Any body who wants to acquire drug regulatory affairs competency should attend the course.
Certificate will be provided at the end of the successful completion of the course
What Drug Regulatory Affairs Department in pharmaceutical company?
Drug Regulatory Affairs refers to all aspects within the pharmaceutical development process and how they are subject to various degrees of regulation. The pharmaceutical law frame, guidelines covering Quality, Safety and Efficacy as well as Health Authorities’ attitudes and requirements etc. have a great influence on the drug development process and the success of it. Hence, regulatory affairs professionals deal with these aspects.
Role of Drug Regulatory Affairs Department
The Regulatory Affairs department is an important part of the organizational structure of pharmaceutical companies. For instance, internally it liaises at the interphase of drug development, manufacturing, marketing and clinical research. Most importantly, they are the key interface between the company and the regulatory authorities. Moreover, Regulatory Affairs Professionals are involved in product development from the beginning.
What Regulatory Affairs Manager do?
Regulatory Affairs Manager oversees the regulation process for products requiring governmental approval, including filing necessary applications and handling all government interactions. Moreover, they coordinates inspection of the organization and contract facilities, and also develops procedures to ensure regulatory compliance.