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Leading in the Field of Regulatory Affairs

Leading in the Field of Regulatory Affairs. Eric D. Kupferberg, PhD Senior Fellow 25 July 2013. Basic Definition of the Field. The essential steps and considerations necessary for a company to gain approval from a regulatory agency for the commercialization of biomedical product

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Leading in the Field of Regulatory Affairs

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  1. Leading in the Field of Regulatory Affairs Eric D. Kupferberg, PhD Senior Fellow 25 July 2013

  2. Basic Definition of the Field • The essential steps and considerations necessary for a company to gain approval from a regulatory agency for the commercialization of biomedical product • The central focus is on the mechanisms and criteria enlisted to show safety and effectiveness of a product and its prescribed usage

  3. Why Do We Need Regulatory Leaders? • Statutes are outdated and vague • Guidance documents are non-binding • FDA approvals, audits, and letters are geared toward particular products and companies • FDA regulations DO NOT define how to achieve compliance • Regulatory approval is a nuanced and negotiated act

  4. Regulatory Stages for New Drugs

  5. Respond to Shomen Chosa Q’s 3 Respond to 2nd Sen. Kyogi Q’s PMDA intro Meeting Preclin Shomen Chosa Clinical Shomen Chosa Reimb. Appl’n Reimb. Aproval FMA Audit & Approval Dossier PreCons Meeting Shomen Chosa Appl Shomen Chosa Approv. Re-submit STED Request 2nd Sen. Kyogi 2nd Senmon Kyogi Final Product Approval FMA Appl. Jichi chosa PMSS proposal 6 Request Senmon Kyogi 1st Senmon Kyogi Re-submit STED Y-Kai Meeting Submit MAH Submit STED 4 Sashi -kai 1 Product marketing Approval GMP Audit Sub’s GMP Audit approvals Bukai Meeting Respond to Senmon Kyogi Q’s 2 Respond to Bukai Q’s Respond to GMP Audit Questions 5 Respond to dossier technical questions Six critical sub-strategies of the Japan approval process

  6. What Are the Basic RA Functions • Primary function = regulatory compliance • Day-to-day job is paper work • Must have knowledge of existing statutes and regulations • Must design careful documentation systems for all steps of approval • Biggest challenge = Regulatory filing and audit

  7. What is the Intermediate RA Work? • Guide product through entire life-cycle, including clinical trials, approval, labeling, marketing, and post-market surveillance • Manage products “across” business units, including legal department, QA/QC, marketing, finance • Agility in working with teams and communicate

  8. The Life Cycle of Biomedical Products

  9. What is Advanced RA Work? • Proficiency in several technical areas, including science, medicine, policy analysis, economics • Ability to accommodate development of new product areas (e.g., nanotechnology, combination products, tissue engineering, genetic therapy) • Strong leadership skills, even without formal authority

  10. What is Advanced RA Work? • Interpretation of international regulations and understanding of trade issues • Lobby governments for changes in regulations, laws, and health policies • Work with investors and executives • Ability to create sustainable competitive advantages for host organization

  11. Crucial Role of “Regulatory Strategy” • Business strategy = deciding where you would like to take your company and the best ways to get there • Many core strategic decisions are really regulatory decisions • Ability to identify process gaps and create new processes • Difference between avoiding losses and maximizing cost-effectiveness of resources

  12. Crucial Role of “Regulatory Strategy” www.priory-analysts.com/uploads/images/Business_system_chart_02.JPG

  13. How to Break into the FieldWhere do RA leaders “come from”? • Chemistry • Engineering • Pharmacology • Quality • Toxicology • Writing • Clinical sciences • Management

  14. Problem with Learning “On the Job” • Knowledge is limited to what the company currently “does” not what it might “want to do” or what it will “have to do” • Reproduce isolation of regulatory affairs • Under-prepared for mergers and acquisitions • Limited ability to advance the profession through research & publications

  15. First Steps to Take • Develop skills and experience in one of the sciences that contribute to product development, manufacturing and marketing (most difficult part) • Learn the regulations that apply to the company’s products • Take courses that provide instruction in applying the regulations in industry • Join Regulatory Affairs Organizations

  16. Northeastern University- MS in Regulatory Affairs for Drugs, Biologics & Medical Devices • Nearly all 44 courses are offered online and on-campus (Boston, Seattle, Charlotte) • Equal focus on medical devices and drugs • Broad curriculum on international topics • Unique emphasis on regulatory strategy, not just regulatory compliance

  17. CURRICULUM 6 Core Courses 4 Specialized Elective Courses 1 Open Elective Course 11 Total Courses Curriculum – Core Courses 6 Core Foundation Courses • Introduction to Drug and Medical Device Regulation • Human Experimentation: Methodological Issues Fundamental to Clinical Trials • New Drug Development • Medical Device Development • Biologics Development • Food, Drug, and Medical Device Law *Note: Students may be required by the department to take RGA6280: Advanced Writing on International Biomedical Topics as a condition of their continued enrollment in the program

  18. CURRICULUM 6 Core Courses 4 Specialized Elective Courses 1 Open Elective Course 11 Total Courses Curriculum – Elective Courses 4 Specialized Elective Courses Choose one course from each of the following areas • 1 Safety and Surveillance Course • 1 Business and Law Course • 1 Development and Strategy Course • 1 International Regulatory Affairs Course 1 Open Elective Course or co-op/internship • Students may choose 1 additional course from any elective course category or a co-op or internship • In order to participate in a co-op/internship all regulatory affairs students must complete the following courses: • RGA 6100 Introduction to Drug and Medical Device Regulations • BTC 6210 Human Experimentation

  19. The Application Process Visit https://app.applyyourself.com/?id=NEU-CPS You will need to provide: • Original Personal Statement (500-1000 words) • Current resume • 2 recommendations • Undergraduate official transcript • Sent directly from your undergraduate institution to Northeastern • TOEFL/IELTS for non-native English speaking students • You do not need to submit GRE/GMAT scores • Send your questions to: cpsadmissions@neu.edu or call 877-668-7727 Already submit your application?Visit www.cps.neu.edu/admissions The next start date: September 9, 2013 Visit www.cps.neu.edu/admissions for additional information

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