Drug regulatory affairs is a crucial aspect of the pharmaceutical industry that ensures the safety, efficacy, and quality of medicinal products. As the demand for new drugs and other therapies continues to increase, regulatory affairs has become an increasingly important field. Regulatory compliance is essential for drug development, registration, and marketing. The regulatory landscape is constantly evolving, with new regulations and guidelines being introduced regularly. Therefore, professionals in drug regulatory affairs must be equipped with the necessary knowledge and skills to navigate these complex regulatory processes. This course aims to provide an in-depth understanding of drug regulatory affairs, covering key aspects such as drug development, clinical trials, regulatory submissions, and post-marketing surveillance. One of the major features of this course is its comprehensive coverage of not just conventional therapies, but also cutting-edge treatments such as biological and cell gene therapies. Students will gain a thorough understanding of the regulatory requirements and approval processes for these advanced therapies, which are rapidly gaining prominence in the field of pharmaceuticals. By enrolling in this course, students will gain a comprehensive understanding of regulatory affairs and be prepared to take on roles in the regulatory affairs departments of pharmaceutical companies or regulatory agencies.
What you are going to learn in this course?
- Introduction to RA
- Guidance on how to refer various regulatory guidelines
- Preparation and submission of Technical documents
- Filling and registration to various regulatory bodies
Who can attend this course?
- Any life sciences/medical students (e.g. B.Pharm, B.Sc. Nursing, BDS, MBBS etc)
- Postgraduate and PhD students from life-sciences/medical background
- Any professional beginners who want to develop regulatory skills
- Academician/Industry delegates
