Drug Development

1 Week

Any body who wants to acquire drug regulatory affairs competency should attend the course.

Certificate will be provided at the end of the successful completion of the course

• Orientation to job related practical aspects for the R&D professionals.
• Simulation to real life working in regulatory affairs department. It help to enhance the regulatory strategic decision making.
• Advance training on drug registration requirements for various regulatory bodies.
• Access to Case Studies to learn about the drug registration steps.

Who should attend this course? 

• Those who are in working in drug discovery and development.
• Drug Discovery R&D personnel who want advance understanding on drug approval process.
• Professionals from drug discovery development.
• Anyone requiring an overview of drug regulatory affairs.
• Fresher or beginners, Those who want to make a career in drug regulatory department.

Few of the similar courses

• International Drug Regulatory Affairs
• US Pharmaceutical and Biopharmaceutical Regulatory Affairs
• Drug Registration and Regulation in China
• Drug Discovery and Development to Commercialization
• European Drug Regulatory Affairs
• Drug Registration and Regulation in GCC countries
• UAE Drug Regulation and Registration

Course Timeline

The course is broken down into four modules:

• The Drug Development Process Regulatory Environment. 
• Training on Stages in the Drug Development Process – the second module provides a detailed overview of the process, taking a look at the life cycle, history, timelines and phases critical to the process. The module covers the product discovery and clinical testing steps essential to the early stages of the drug development process. After that, course provides detailed understanding on the activities needed for regulatory approval, manufacturing scale-up and post-market issues such as adverse event monitoring or reporting and patent exclusivity.
• Preclinical / Non-clinical Stage -Training on the preclinical studies (studies in animal subjects). Topic includes preclinical pharmacology, pharmacokinetic, GLP compliance and more.
• Clinical Steps-This covers what happens after discovering an NCE, conducting preclinical trials and completing the IND/CTA application. Attendees will learn the different phases of these clinical studies and about the NDA/MAA application.
• Launching and marketing of Innovative Branded Drug – marketing planning, strategic initiative, usage of clinical trial in marketing, Product Life cycle Management, forward and backward integration for the branded pharmaceuticals for managing high ROI.