Regulatory Affairs as a Career Path
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23. Jan 2015•0 gefällt mir•4,164 views
Regulatory Affairs as a Career Path
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Regulatory Affairs as a Career Path
- 1. 1 Plamena Entcheva-Dimitrov, PhD, RAC On-line Course www.PreferredRegulatoryConsulting.com
- 2. www.PreferredRegulatoryConsulting.com 2 The Preferred Regulatory Consulting content in this presentation is copyright protected under United States law and applicable international copyright laws.
- 4. Why Regulatory? What do we do? What is the growth potential? What are the necessary skills? What do you need to know and where do you learn it? 4www.PreferredRegulatoryConsulting.com
- 5. High impact on the company Interactive Stimulating See all – do all Sense of accomplishment www.PreferredRegulatoryConsulting.com 5
- 6. Study, interpret and apply the regulations Advise the company on newly published or on upcoming changes to existing laws/regulations / standards Work with R&D on product development – follow regulations from product’s inception Prepare submissions to regulatory agencies Involved in the clinical trial design and conduct Standard Operating Procedures Continuously train the organization on regulations/guidances/directives/standards Safety reporting pre- and post-market Involved in product recalls 6www.PreferredRegulatoryConsulting.com
- 7. 7 Regulatory Product Development EngineeringClinical Non-clinical Process Development Chemistry Reimbursement IP Lawyer Quality Assurance www.PreferredRegulatoryConsulting.com
- 8. The sky is the limit!!! www.PreferredRegulatoryConsulting.com 8 Individual contributor Management track Expand into Clinical Affairs, Quality Assurance or both
- 12. PhDs MDs/PharmDs Lawyers MBAs Engineers MS Chemists 12www.PreferredRegulatoryConsulting.com
- 13. Analytical Critical thinker “Roll up your sleeves and get the job done” approach “Can do” attitude Creative Team player/excellent interpersonal skills Integrity Detailed oriented Excellent writing skills Mentor/educator 13www.PreferredRegulatoryConsulting.com
- 14. FDA responsibility, authority, jurisdiction and structure: Inspections Warning letters Recalls Suspension / withdrawal of approvals Seizure Injunctions Civil and criminal penalties EU Directives, Regulations Health Canada Australian Therapeutic Goods Administration (TGA) Many other emerging markets (e.g. Brazil, China, India) 14www.PreferredRegulatoryConsulting.com
- 15. 15 • Food, Drug and Cosmetics Act of 1938 • Medical Device Amendments of 1976 • The Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 Laws Center Specific Guidance Documents Regulations: Code of Federal Regulations Title 21 • Good Laboratory Practices • Conduct of Human Research • Labeling Requirements • Recalls • Safety Reporting • Facility Registration • Audits / 483s www.PreferredRegulatoryConsulting.com
- 16. 16 Directives Standards (ISO, IEC) Guidances (MEDDEVs) Consensus statements Interpretative documents www.PreferredRegulatoryConsulting.com
- 17. MEDICAL DEVICES DRUGS / BIOLOGICS I. Quality Systems Regulations II. 21 CFR 807 and 814 for submission content and format: 510(k), de novo, PMA, HDE III. IDE for clinical studies IV. Design Control Concept V. EU Medical Device Directives VI. ISO Standards VII. Complaint handling and vigilance reporting I. GMPs II. 21 CFR 314 for submission content and format : NDA, BLA III. IND for clinical studies IV. Quality by Design V. EMA – EU legislations and regulations VI. ICH Guidelines VII. Vigilance reports 17www.PreferredRegulatoryConsulting.com
- 18. 18 On-line courses Universities Social networking, e.g. LinkedIn The regulators www.PreferredRegulatoryConsulting.com
- 19. Networking, networking, networking Find a mentor Open-minded Positive attitude Self-educate 19www.PreferredRegulatoryConsulting.com
- 20. 20 You have completed a 30-minute regulatory affairs on-line training You can print this page for your records www.PreferredRegulatoryConsulting.com
- 21. 21 Please email us at info@preferredregulatoryconsulting.com www.PreferredRegulatoryConsulting.com