REGULATORY AFFAIRS STRATEGIC PLANNING

Key Learning Area for the course

• Drug Development to Commercialization.
• Innovation Management in pharmaceutical industry.
• Generic Drug Strategic Planning.
• Region specific drug registration and regulation strategy.
• Devise the appropriate marketing authorization strategy for specific country or region.
• Detail understanding on the portfolio management process.
• New Innovator’s Strategic Management – LOE strategies for Innovator’s Brand
• Evergreening of pharmaceuticals
• Licensing of pharmaceuticals – In and Out Licensing
• Compulsory Licensing
• Generic Drug Strategic Management – Para IV Filing / Handling of Para IV notices
• ANDA development strategies – Suitability petition vs. 505b2 pathway
• Pay for Delay
• REMS strategic planning

• Understanding on regulatory affairs strategic planning from drug discovery development to commercialization. Therefore fundamental to advance R&D management process training is included.
• Additionally, the course provide pharma portfolio management skill training.
• Advance Simulation provide to real life learning experience. Hence it helps to improve the decision making skills of the participants.
• Biotech, biosimilar products strategic management is also part of the course.
• Above all, course participants are exposed to Global Pharma Business Case Studies.
• 24×7 access of the course. Hence you can attend the course at your own preferred date and time.

Who should attend?

• Person working in the pharmaceutical manufacturing department / F&D personnel
• Regulatory Affairs personnel
• Research and Development personnel
• Quality Assurance & Control personnel
• Development and Preparation of Submission Materials
• Project management professionals who must have detailed insight on the regulatory strategic management process.

Minimum qualification Graduation in any discipline.

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

Related courses

• Pharmaceutical Brand management Course >> Click here
• Pharma marketing course >> Click here
• Sales Management Training >> Click here
• Biopharma Business Management >> Click here
• Brand valuation >> Click here

What is strategic regulatory planning?

• Regulatory strategic planning is the process of planning, monitoring, analysis and assessment of all what is must for an organization to meet its goals and objectives. Because of this, in all leading pharma and biotech companies, there is a separate division called strategic management cell. They work on planning organization’s strategy.
• Pharma strategic management professionals involve in changes in organization’s business process. As a result, they bring the success to organization.
• Today pharma and biotech organization are looking for trained professionals who understand all aspects of strategic planning. However, there is a lack of professionals who understand complex pharma and biotech business environment.

What skill Pharma Strategic Manager should have?

Firstly, Pharma Strategic Manager should be master of the drug discovery, development to commercialization process. They should have excellent and updated regulatory knowledge. Secondly, professionals should have the fundamental understanding on portfolio management process. Thirdly, they should have strategic business skills, acumen and competency. Last but not the least, they should have basic financial management skills. Most importantly, the course covers deal valuation tools and techniques.

To summarize, strategic management professionals should have overall pharma business functional understanding.

Do the course cover both pharmaceutical and biopharmaceutical strategic management?

• Yes. It’s cover the both pharmaceutical and biopharmaceutical industry.

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