This program includes 5 topics:
1- Introduction to Pharmaceuticals, Natural Health Products, Medical Devices, and Biotechnology products
2- Pharmaceutical Regulatory Affairs
3- International Regulatory Affairs Guidelines (ICH)
4- Preparing a New Drug Submissions fro drug registration
5- Post Approval Activities and Regulatory Compliance
This program is specifically designed to prepare students for a better understanding of Pharmaceutical Regulatory Affairs in a compact and easy to absorb format. The aim is to give a clear understanding international guidelines and local laws and regulations affecting pharmaceutical, biological, natural health products and medical devices. The course also covers in depth discussion of international food and drugs act, regulations and guidelines.
The International Regulatory Affairs Guidelines and Regulatory Submissions course provides in depth knowledge and hands-on work with various types of regulatory submissions. The completion and applications of regulatory submissions such as CTA, NDS/A, ANDS/A, and CTD are discussed in details. There is an in-depth discussion of the regulatory review process. Strategies on how to have a successful submission is discussed in details.
The Post Approval activities and compliance provides an overview and analysis of the various regulatory activities that take place post-approval: In particular, the current regulatory climate will be discussed in depth and numerous examples will be provided to illustrate effective filing of notification techniques. Common issues which have caused difficulties for pharmaceutical firms will also be discussed. The course also covers in depth discussion of international food and drug laws, regulations and guidelines.