Introduction
Course Type
Who should attend
Learning outcome
Related Courses
This comprehensive training program is designed to provide participants with a deep understanding of drug registration, regulation, and nutraceuticals in India. The course covers key regulations, guidelines, and procedures required for registering pharmaceutical products, nutraceuticals, and dietary supplements in India, ensuring compliance with the standards set by regulatory authorities like the Central Drugs Standard Control Organization (CDSCO) and the Food Safety and Standards Authority of India (FSSAI).
Participants will learn about drug and nutraceutical approval processes, clinical trials, good manufacturing practices (GMP), and the overall drug regulatory landscape in India. This course is suitable for professionals seeking to navigate the complexities of India’s drug registration system effectively.
The Indian medical regulatory system has become more complicated, and new drugs can take a year or more to be approved for marketing.
Ever-changing laws and regulations are driving demand for regulatory affairs professionals to provide the current needs of industries for the global competition and who can help pharmaceutical companies to effectively bring their medical products to the Indian market.
In today’s competitive scenario, the reduction of the time taken to launch the product is imperative and hence vital for company’s success. The course provides in-depth understanding about the innovators drugs, biologics and generics, biosimilar approval process in detail. New drug or biologics clinical trial requirements are also discussed in this course.
The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.
The course can be completed at any pace, allowing the user to stop and start at their leisure.
Course Snapshots
- Title of the training: RYD-049
- Course Code: Fundamental Training on Drug Registration and Regulation in India
- Nature of the training: Online, Self Paced Learning
- Duration of the course: 3 days
- Course Certificate: Certificate will be provided at the end of the successful completion of the course
Online distance learning course. Hence, course can be accessed online across anywhere 24×7.
Who Should Attend:
- Regulatory, quality, design, development, manufacturing, marketing managers and personnel handling Indian Business Operation
- Helpful to all pharma manufacturer/importer, regulatory, preclinical, formulation scientists, and clinical trial professional who are involved directly or indirectly in new drug registration process.
- Need integrated knowledge and broad perspectives which you need to effectively manage the regulatory process for approval of new drugs in India
- Drug manufacturers and importers
- Research and Development teams
- Regulatory consultants
- Students and professionals seeking to understand the Indian drug regulatory system
By the end of this course, participants will be able to:
- Understand the key regulatory frameworks governing drug registration in India.
- Navigate the drug registration process and submit necessary documents for approval.
- Comprehend the regulatory guidelines for clinical trials, manufacturing, and post-market surveillance.
- Apply knowledge of GMP, GxP, and other quality standards in regulatory processes.
- Gain insights into the registration processes for biologics, vaccines, cosmetics, and medical devices.
