Introduction
Learning Areas
Features
Related Courses
Who should attend
About regulatory 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-025
- Title of the Course: Advanced Certification in Regulatory Affairs Strategic Planning (ACRASP)
- Types of learning: Online, self paced learning.
- Course Duration: 1 Month
- Eligibility: Minimum qualification Graduation in any discipline.
- Course Certification: Certificate will be provided at the end of the successful completion of the course.
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.
Regulatory Affairs Training 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.
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Section 1Discovery Development Pathway : Strategic Insight
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 6Biological Licensing Application (BLA) | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 7Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 8Exploratory IND Vs. Traditional IND
Lecture 9FDA Forms and How to fill the resources
Lecture 10Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 11Practical Queries on different USFDA application and Filing
Lecture 12USFDA expedited programs
Lecture 13Emergency Use Authorization (EUA) | EUA Pathways | Criteria | Justification | Early Discussion with FDA | LOA | Factsheets
Section 2Preformulation and Non-clinical - Regulatory and Strategic Planning
Lecture 14Preformulation Study in Drug Development
Lecture 15Regulatory Requirements for Preformulation Study
Lecture 16Logical Sequence of Preformulation Study | Case Insights | Strategies for preformulation studies
Lecture 17Regulatory Requirements for Non-clinical Studies | Types of Non-clinical studies
Lecture 18Types and Timing of Non-clinical Studies
Section 3Patent & Exclusivities : Strategic Insights
Lecture 19Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 20Orphan Drug Designation
Lecture 21Regulatory Strategies in different phases of Clinical Trial
Lecture 22Advance study on Para IV Filing
Lecture 23Para IV Notices
Lecture 24Authorized Generics: Key Understanding
Lecture 25Evergreening - Patent Life Extension Strategies
Lecture 26Compulsory Licensing
Lecture 27Licensing & Technology Transfer
Lecture 28In-Licensing Vs. Outlicensing
Lecture 29LOE Strategies for Innovator Brands with case study
Lecture 30Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 31Drug Repurposing
Section 4Regulatory Submission Strategic Planning
Lecture 32Fundamental of CMC | Detailed understanding of CMC section writing | Important Points regarding CMC | Drug Product and Drug Substance | Excipient, FP, Analysis and Stability Study Requirements
Lecture 33505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 34Advance Learning on 505B2 Pathway
Lecture 35Common Technical Document (CTD)
Lecture 36CMC Dossier & Compliance Management
Lecture 37Electronic Common Technical Document (ECTD)
Lecture 38Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 39Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 40Key Consideration for Drug Master File Preparation and Submission
Lecture 41Practical Understanding on Drug Master File Preparation and Submission
Lecture 42Associated Learning: Site Master File - Detailed Understanding
Lecture 43Detailed Understanding on ANDA Submission Dossier
Lecture 44Prior Approval Submission
Lecture 45Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 46NCE Vs. 505b2 application - Case Based Learning
Lecture 47FTF - 180 Days Exclusivity - Case Based Learning
Lecture 48Classic case study of the 505b2 filing : Case Based Learning
Lecture 49Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Section 5BA BE Strategic Planning
Lecture 50PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 51Bioequivalence Study | Study design | Different types of BE Studies
Lecture 52Bioequivalence Study | Study design | Parallel Study | Crossover study design | Other alternative study designs | Blood Sampling Planning | Analyte | Bioanalytical Methods Validation | Statistical Model | Ln Transformation | Dose normalisation | Confidence interval acceptance criteria
Lecture 53Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission
Lecture 54Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study
Lecture 55Bioequivalence Study - Discussion - Dissolution Testing
Lecture 56Bioequivalence Study - Generic Approval and Additives Labeling Requirements
Section 6Variation Management
Lecture 57Introduction to Variation Management | Reasons for Variation | Working in Variation Department
Lecture 58Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.
Section 7GMP and Quality issues - Handing and Managing Critical Alerts
Lecture 59Complete Response Letter | Key understanding | Management and Action Plan
Lecture 60Data Integrity issues in Pharmaceutical Industry : Detailed Understanding
Lecture 61Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter
Lecture 62Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 63RTQs | Response to Queries | How to handle Regulatory Queries
Section 8EU Drug Regulatory Strategic Management - Submission Strategic Planning
Lecture 64Introduction to EU Regulation
Lecture 65Orientation to European Countries and National Regulatory Bodies
Lecture 66EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 67Overview of EU Regulation
Lecture 68EMA and EMA Authorisation Process
Lecture 69EU MA Application Types and Strategic Planning
Lecture 70EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure
Lecture 71EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 72Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 73EU Orphan Medicinal Products Regulation
Lecture 74IMPD | Significance | Format of IMPD | Differences with CTA, IB, IND
Lecture 75Investigator’s Brochure | Significance | Format of IB | Preparing different sections of IB
Lecture 76Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 77EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation
Lecture 78EU Prime Designation
Lecture 79Accelerated assessment by EMEA
Lecture 80EU Adaptive Pathway
Section 9Biologic Regulatory Strategic Management
Lecture 81Regulatory Requirements for Biosimilar | Stepwise evidence based development | Analytical Similarity | Clinical Study | PKPD study requirements | CMC expectation of Biosimilar
Lecture 82Biosimilar Approval and Patent Management | Strategic Pathway of Patent Negotiation and Litigation in Biosimilar Approval | Patent Dance | FAQs on Biologic Patent Management
Lecture 83Biosimilar launch case study | Patent Dance Framework
Lecture 84Biosimilar Launch Framework
Lecture 85Biosimilar 180 Day Notice
Lecture 863(A) List | Significance | Importance | How to interpret
Lecture 87Steps to win over innovator patents | Step wise planning
Lecture 88Biosimilar Launch Project Roadmap with defined stages of project
Lecture 89Timing of Biosimilar Submission and Approvals | Two Scenario based timeline assessments
Lecture 90Hands on Training on Reference Biologic Patent | Classify RPS Biologic Patents | Case Simulation
Lecture 91How to work on RPS’s Patent | Walkthrough | Case Study
Lecture 92Biosimilar Launch Project With Milestones
Lecture 93Analysis of Biologic Patents | Work Assignments
Lecture 94Biologic Patent Insight Worksheet
Lecture 95Patent Thickets | Concept | Implication | Case Based Learning
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