RA Specific Presentation for students...
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RA Specific Presentation for students...
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- 2. 2 REGULATORY AFFAIRS PROSPECTIVE ROLE & STRATEGY IN DEFINE REGIONS PRESENTED BY: WAQAS ALI KHAN (RA Professional) Friday, Februar y 28, 2025
- 3. 3 TOPICS TO BE COVER…… 1) Role of regulatory function head in a branded generic pharmaceutical and consumer health / nutraceutical organization operating in SA, SEA and CIS region. 2) How will you ensure "first time right" registration of the products for such a company. Countries to focus are VN, PHP and CIS region. 3) What will be your strategy to ensure that your company is among the top 3 companies to launch a branded generic pharmaceutical in the countries mentioned above. Friday, February 28, 2025
- 4. 4 Friday, February 28, 2025 Role Of Regulatory Function Head In A Branded Generic Pharmaceutical And Consumer Health / Nutraceutical Organization Operating In SA, SEA And CIS Region. 04 SPECIFIC CORE REGULATORY CRITERIA FOR DEFINE REGIONS SEGMENT WISE COLLECTIONS OF DATA REGION WISE • Primary or secondary data processed , analyzed & accepted by the relevant Authorities. o Primary Data = Product Registration Guideline, Necessary Documentation Quality wise & Different Regulatory Authorities Studies. o Secondary Data = Relevant Research Studies like Clinical Trial, BA/BE etc.. REGULIZE OBJECTIVE PRODUCT WISE • Marketing competition, authorization along-with with Registration , cGMP Inspections (if needed) & Quality Assurance of Products and labelling, prescribing with trade related issues.
- 5. 5 Friday, February 28, 2025 SPECIFIC CORE REGULATORY CRITERIA FOR DEFINE REGIONS SEGMENT WISE DEFINE PRODUCTDESIGN REGULATION, SITES & EXPECTED OUT- COME • Interrupted time series analysis and/or repeated measures studies and/or controlled or uncontrolled Factors before and after studies. • Public and/or private health care institutions and/or retail / tender market sector feedback • Single & Combined Molecule Review with Reference according to Market Needs. ENSURING QUALITY OF MEDICINES • The programme based rational use of medicines to increase trust in the quality of medicines. Manufacturer / Health facilities draw medicine samples and test it centrally or any independent lab. The wide dissemination of these results can help to increase the confidence of consumer / market in concerns to express about quality.
- 6. 6 Friday, February 28, 2025 REGULATORY AFFAIRS STRATEGY FOR DEFINE REGIONS Establish & Elaborate a Submission & cGMP Inspection Plan for each Country of the Region, according with the needs of the Business. Review the local Regulatory Requirements as well to supervise and follow up. Products Submission plan should be according to the launch plan of the Region. Understand the different Regulations, in order to provide the proper support to each country. Contribute to the preparation of dossiers of products manufactured by third-parties (when applicable), to ensure to comply with the requirements per country.
- 7. 7 Friday, February 28, 2025 REGULATORY AFFAIRS STRATEGY FOR DEFINE REGIONS Objections: Review/Provide the strategies for handling objections received from the MoHs. Provide a Plan to mitigate the risk of a possible delay of the approvals that may affect to achieve the goals in the Region. If needed, provide to the Regulatory team negotiation strategies with the Health Authorities, in order to expedite the approval of the products. Interact and provide support to the different stakeholders of the Business as: Commercial/Marketing/Supply/Medical/Quality/Facility. Make sure to get all the approvals before releasing the products in each Country
- 8. 8 Friday, February 28, 2025 • How will you ensure "first time right" registration of the products for such a company. Countries to focus are VN, PHP and CIS region. ENSURE THE FOLLOWING STEPS FOR REGISTRATION OF PRODUCTS Quality By Design (QbD) Overview Safety and efficacy should be properly identify, no matter how many tests or analyses have been done to verified its quality in respective MOHs because QbD begins with the recognition of Quaility. In other words, quality must be built into the product. Therefore, we need to ensure the Quality of Products by design. Keeping Pace With Market Trends Reduce Product development times, get to market as quickly as possible and manufacture efficiently. In addition, it is important to mitigate potential risks, both from regulatory registration as well as product robustness – no one wants to put something on the market that they then must call back! In terms of registration.
- 9. 9 Friday, February 28, 2025 ENSURE THE FOLLOWING STEPS FOR REGISTRATION OF PRODUCTS Filled-Up Technical Gaps According TO Technical Standards Overage of active ingredients and tolerance limits according to labeling claim Registration of vitamins, minerals, and supplements (VMS) products as generic OTC drugs (under pharmaceutical products regulations) rather than health supplements. Consolidates the quality data under a single module to facilitate review. Unlike the ICH-CTD where Module 2 contains the Quality Overall Summary and Module 3 contains the body of Quality data. Inspection of QA Systems Change control Complaints handling Corrective Action Preventive Action (CAPA): Correction and prevention of unacceptable quality system practices Quality Risk Management Qualification / Validation Batch record review Product quality review On-going stability programme
- 10. 10 Friday, February 28, 2025 • What will be your strategy to ensure that your company is among the top 3 companies to launch a branded generic pharmaceutical in the countries mentioned above? KEY SUCCESS FACTORS WITH BRANDED GENERICS Recalibrate Regulatory Affairs Ability To File For The Fastest Route For Approval To Outpace Generics Know How To Navigate Government Relationships. Ability to file for the fastest route for approval to outpace generics Know how to navigate government relationships Engage In Portfolio Marketing Physician engagement and brand equity. Motivate & Enable sales teams to promote multiple products with physicians. Establish sustained local capabilities with strong local talent Quality manufacturing is a show of goodwill to local authorities with High demand for local talent is making hiring/retention expensive.
- 11. 11 Friday, February 28, 2025 KEY SUCCESS FACTORS WITH BRANDED GENERICS Innovation Or Efficiency: Which Route Makes Sense For Your Business? As these strategies start to take hold in the generic drug making business, we expect the market to split into two categories: innovation players and efficiency players. The innovation players will focus on innovative drug development, participating in branded and generic markets to sidestep some of the pressures of selling traditional generic drugs. Efficiency players will operate in markets with relatively low prices and focus on traditional generic drugs with the objectives of gaining scale and minimizing costs to offset pricing pressures. Become bigger and better (high investment/ high risk/ high growth potential) Consolidation among generic drug makers could strengthen the hand of manufacturers when they negotiate with wholesalers or pharmacy benefit managers. Consolidation could also address issues of oversupply in some products. Some larger drug makers have sold or attempted to divest some of their generic drug operations. For example, Pfizer merged its Upjohn division with Mylan, which will be called Viatris and will be the largest generics manufacturer in the world. Some of their product portfolios may need divestment to clear antitrust approvals, creating opportunities for some manufacturers to add scale
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