A step-by-step guide on Regulatory Agency activities
- Total Hours: 225 hrs; 75 hours of learning content plus 100 hours of assessments and 50 hours of practicals
- Learn from experts who have established themselves successfully in the industry
- Get enabled to implement your ideas in new vertices of Regulatory Affairs
The regulatory affairs industry oversees how foods, drugs, and medical products are developed, tested, manufactured, marketed, and distributed to certify that they meet regulatory standards for human use.
Regulatory affairs professionals are responsible for ensuring manufacturers’ compliance with applicable global legislative and regulatory requirements at each stage of product development. In the drug, medical device, and biologic product industries, these phases include research and development, clinical trials, regulatory submissions, manufacturing, marketing, distribution, reimbursement, and post-market surveillance. In the food industries, regulatory professionals engage with products, facilities, manufacturing operations, and distributors along the farm-to-fork lifecycle.
These regulatory professionals play a critical role in the development and distribution of medical technological advancements and disease-free food, improving people’s health and welfare around the world.
The Certificate Course in Regulatory Affairs from Clinosol Research Pvt. Ltd. has been designed in a way to provide the student with the insights required to start a career in Regulatory Affairs domain.
- What Will You Learn?
- Who Can Learn?
By the end of the course, you will have the insights on the complete understanding of different regulatory bodies/agencies, regulations for major countries and best practices for documentation and reporting in the industry.
Regulatory Affairs Work Flow
- Step-by-step flow of processes of Regulatory Affairs
- Different Regulatory Bodies like FDA, EMA, TGA and their regulations
- Review marketing, legal, and technical documentation, including case files and clinical research reports
- Analyze new and existing regulations in relation to an organization’s products or
- Guidelines for Good Documentation Practices
Graduates and postgraduates from pharmacy such as B. Pharmacy, M. Pharmacy, & Pharm. D.
Other Course Options: Clinical Research
On successfully completing all the learning modules, you will be awarded the,
‘Certificate in Regulatory Affairs/Clinical Research & Regulatory Affairs’ certification.