InstructorRoyed Training
TypeOnline Course
Price$290 USD / 15950 INR
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About regulatory strategic planning

Regulatory Affairs Strategic Planning

This online training provides key portfolio management and regulatory affairs strategic planning skills for pharmaceutical organization. Regulatory Affairs Strategic Management  plays vital role in pharmaceutical business and indeed innovative and aggressive regulatory strategy helps organization to differentiate from other. Hence, this short 1 week course provides quick review on overall understanding how regulatory strategic planning process works. 

This course is designed to provide comprehensive understanding on regulatory strategic management process which is a key skill for pharma middle level managers.

The course is designed to create the new-edged Strategic Business Manager for pharma and biotech industry. Course focuses on how pharma and biotech strategic business manager works and their key responsibilities and job functions.

Course Code: RYD-005

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

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.


Section 1
Lecture 1R&D Process & Introduction to drug discovery
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA) 
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA) Filing 
Lecture 6Complete Response Letter | Key understanding | Management and Action Plan
Lecture 7505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 8Authorized Generics: Key Understanding
Lecture 9Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 10Orphan Drug Designation 
Lecture 11Advance Learning on 505B2 Pathway
Lecture 12Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Section 2
Lecture 13Regulatory Strategies in different phases of Clinical Trial
Lecture 14Advance study on Para IV Filing
Lecture 15Para IV Notices
Lecture 16Evergreening - Patent Life Extension Strategies
Lecture 17Pay For Delay Strategy
Lecture 18REMS Strategic Planning 
Lecture 19Compulsory Licensing
Lecture 20Licensing & Technology Transfer
Lecture 21In-Licensing Vs. Outlicensing
Lecture 22Orphan Drug Designation 
Lecture 23Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 24Drug Repurposing
Lecture 25Practical Queries on different USFDA application and Filing 
Lecture 26New Indication Approval Process and Promotion 
Lecture 27OTC Switch