Regulatory Affairs Profession

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The presentation is about: Drug Regulatory Affairs as a profession, Scope & Responsibilities in life cycle management of a drug and role of RA in the drug approval process.

Text of Regulatory Affairs Profession

  • 1. Regulatory Affairs Profession Ms. Anagha Maharao Institute of Pharmaceutical Management Escalating Efficiency of Pharma Aspirants

2. Pharmaceutical & Clinical Research Industry most regulated among all the industries. Every drug before getting market approval must undergo rigorous scrutiny and clinical trials to ensure its Safety, Efficacy & Quality. Standards are set by regulatory authorities. RA department acts as a crucial link between company, products & regulatory authorities. Introduction 2 InstituteofPharmaceuticalManagement 3. What is DRA?? Unique mix of science and management to achieve a commercially important goal. It touches everything relating to drugs from the development manufacture and marketing. RA takes care of Design = Development Plan Co-ordination = Writing/ reviewing, supervising Construction = Assembling & Submission management 3 InstituteofPharmaceuticalManagement 4. Lifecycle management ranges from Drug Discovery post-marketing stage of the process. From Drug development to commercialization, each step is regulated. Scope 4 InstituteofPharmaceuticalManagement 5. Responsibilities of RA professional Keep up-to-date about international legislation, guidelines and customer practices. Update with company's product range. Compliance of company's product with current regulations Impart training to R&D, Pilot plant, ADL on current regulatory requirements Formulate regulatory submission strategies. 6 InstituteofPharmaceuticalManagement 6. Prepare IMPD, DMF, ANDA, MAA, Dossiers amendments & supplements etc as per regional guidelines, submit them to regulatory authorities in a specified time frame Monitor progress of all registration submissions 7 Responsibilities of RA professional [Contd] InstituteofPharmaceuticalManagement 7. Respond to queries as they arise and ensure that registration/approvals are granted without delay. Handle regulatory and customer inspections, review audit reports and compliance Arranges consultations and meetings between the firm and government regulatory agencies 8 Responsibilities of RA professional [Contd] InstituteofPharmaceuticalManagement 8. 9 Company success depends on reduction of time taken for a drug to reach market. Inadequate reporting of data may prevent a timely positive evaluation of a marketing application Proper conduct of RA activities is therefore of considerable economic importance for the company. NO DMF/ DOSSIER NO REGISTRATION NO SALE Importance of RA InstituteofPharmaceuticalManagement 9. Regulatory Agencies 10. Country Name of Regulatory Authority Website USA Food and Drug Administration [FDA] www.fda.gov Europe European Directorate for the Quality of Medicines and Healthcare (EDQM) www.edqm.eu European Medicines Agency (EMA) www.ema.europa.eu Heads of Agencies for the European Union http://www.hma.eu/ 10 InstituteofPharmaceuticalManagement 11. Country Name of Regulatory Authority Website Japan Ministry of Health, Labour and Welfare (MHLW) www.mhlw.go.jp/english Pharmaceuticals and Medical Devices Agency (PMDA) www.pmda.go.jp/english/ UK Medicines and Healthcare products Regulatory Agency (MHRA) www.mhra.gov.uk India Central Drugs Standard Control Organization. www.cdsco.nic.in 11 InstituteofPharmaceuticalManagement 12. How to Keep Up With the Constantly ChangingRegulatoryLandscape? Monitor Agencys websites Subscribe to relevant journals, newsletters Get daily e-mails from regulatory websites, commercial information provider websites 22 Attend relevant conferences/advis ory meetings Talk to colleagues and consultants Employ a regulatory information database In-house or Paid Joining information blogs InstituteofPharmaceuticalManagement