Course Code: KPE-C-054
Course Title: Fundamental Training in Drug Regulatory Affairs
Type of Course: Online Certification Course
Course Duration: 1 Week
Course Certification: Yes. Course completion and Course gradation certificate will be provided
Course Objectives: The Regulatory Affairs department is an important part of the organisational structure of pharmaceutical companies. Internally it liaises at the interphase 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.
Who should attend this course?
- Fresher/Beginners, Those who want to make a career in drug regulatory department
- Those who are in regulatory affairs and related department
- Professionals from drug discovery development
- Anyone requiring an overview of drug regulatory affairs fundamental knowledge
Certificate will be provided at the end of the successful completion of the course
Additional Resource:
- View comparison of 1 Week, 1 Month, 1 Year Advance and 1 Year Executive Program >> Click here
