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By: Shabeena Zaidi
<ul><li>a dynamic and challenging profession </li></ul><ul><li>gives strategic and technical advice for product developmen...
<ul><li>The Regulatory Affairs professionals keep track of the changing legislation in  the regions in which the company d...
<ul><li>Present registration documents to regulatory agencies, and carry out negotiations necessary to obtain  marketing a...
<ul><li>Reduction of the time  taken to reach market is critical to product’s and the company’s success ensured by R.A.  <...
<ul><li>The Regulatory Affairs Professionals Society, RAPS,  http://www.raps.org   </li></ul><ul><li>The Organisation for ...
<ul><li>They offer: </li></ul><ul><li>Education and training,  </li></ul><ul><li>Professional development,  </li></ul><ul>...
<ul><li>Founded in 1976.  </li></ul><ul><li>International membership organization of regulatory professionals  </li></ul><...
<ul><li>Pharmaceuticals </li></ul><ul><li>Medical devices  </li></ul><ul><li>In vitro diagnostics </li></ul><ul><li>Biolog...
<ul><li>They come in contact with  pharmacologists, toxicologists, analytical chemists, pharmacists, medical doctors and s...
<ul><li>Influence </li></ul><ul><li>Negotiate </li></ul><ul><li>Persuade </li></ul><ul><li>Present </li></ul><ul><li>Commu...
<ul><li>Team player (cross-functionally) </li></ul><ul><li>Calm under pressure </li></ul><ul><li>Interactive </li></ul><ul...
<ul><li>How long should the drug effect last? </li></ul><ul><li>What will the dose strength and dosing frequency be?  </li...
<ul><li>1.Developing a draft package insert:  </li></ul><ul><li>  </li></ul><ul><li>Team  defines specific claims and  con...
<ul><li>2. Getting buy – in to the claims: </li></ul><ul><li>Identifying company’s internal stakeholders, to approve finan...
<ul><li>3. Designing the clinical trials: </li></ul><ul><li>Team  identifies  clinical endpoints to deliver claims and pro...
<ul><li>Team can assess:  </li></ul><ul><li>Drug drug interaction & organ impairment, </li></ul><ul><li>metabolism pharmac...
<ul><li>Team members should develop questions for meeting. </li></ul><ul><li>Questions regarding </li></ul><ul><li>Any  to...
<ul><li>It is important to balance continuity with flexibility so that the project team is not pulled back and forth. </li...
<ul><li>Team should not try to prevent change but should control it to the project’s advantage. </li></ul><ul><li>Too much...
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Regulatory Affairs

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Regulatory Affairs

  1. 1. By: Shabeena Zaidi
  2. 2. <ul><li>a dynamic and challenging profession </li></ul><ul><li>gives strategic and technical advice for product development, </li></ul><ul><li>contributes commercially and scientifically to the success of a development programme and company. </li></ul><ul><li>ensures public health by to controlling safety and efficacy of products. </li></ul>
  3. 3. <ul><li>The Regulatory Affairs professionals keep track of the changing legislation in the regions in which the company distributes its products. </li></ul><ul><li>They advise on : </li></ul><ul><ul><li>Legal and scientific restraints and requirements, </li></ul></ul><ul><ul><li>Collect, collate, and </li></ul></ul><ul><ul><li>Evaluate the scientific data that their R&D Dept. generates. </li></ul></ul>
  4. 4. <ul><li>Present registration documents to regulatory agencies, and carry out negotiations necessary to obtain marketing authorisation for products. </li></ul><ul><li>Give strategic and technical advice in their companies, right from the beginning of the development of a product. </li></ul><ul><li>Their RA dept must be aware of the regulatory requirements in all the company’s export markets. </li></ul>
  5. 5. <ul><li>Reduction of the time taken to reach market is critical to product’s and the company’s success ensured by R.A. </li></ul><ul><li>Inadequate reporting of data or release of product with incorrect labelling, may result in loss of several millions sales unit, reduction in confidence of the investors, patients. </li></ul><ul><li>A good Regulatory Affairs professional will help to maximise the cost-effective use of the company’s resources. </li></ul><ul><li>This Dept. is first point of contact between the government authorities and the company. Officials respond better to a company whose representatives are scientifically accurate and knowledgeable. </li></ul>
  6. 6. <ul><li>The Regulatory Affairs Professionals Society, RAPS, http://www.raps.org </li></ul><ul><li>The Organisation for Professionals in Regulatory Affairs, TOPRA, http://www.topra.org </li></ul><ul><li>Drug Information Association (DIA), the Food and </li></ul><ul><li>Drug Law Institute (FDLI) and international </li></ul>
  7. 7. <ul><li>They offer: </li></ul><ul><li>Education and training, </li></ul><ul><li>Professional development, </li></ul><ul><li>Competence certification </li></ul><ul><li>Codes of ethics in RA. </li></ul>
  8. 8. <ul><li>Founded in 1976.  </li></ul><ul><li>International membership organization of regulatory professionals </li></ul><ul><li>RAPS work in all areas of the healthcare product lifecycle, </li></ul><ul><li>Ensures that products are safe and effective. </li></ul><ul><li>Provides education, training, certification, research, publications and career development. </li></ul><ul><li>Website [email_address] </li></ul>
  9. 9.
  10. 10. <ul><li>Pharmaceuticals </li></ul><ul><li>Medical devices </li></ul><ul><li>In vitro diagnostics </li></ul><ul><li>Biologics and biotechnology </li></ul><ul><li>Nutritional products and </li></ul><ul><li>Cosmetics </li></ul>
  11. 11. <ul><li>They come in contact with pharmacologists, toxicologists, analytical chemists, pharmacists, medical doctors and statisticians. </li></ul><ul><li>Assimilate information by such specialists. </li></ul><ul><li>Present that information to regulatory authorities. </li></ul><ul><li>Feed-back their opinions to the rest of the company. </li></ul>
  12. 12. <ul><li>Influence </li></ul><ul><li>Negotiate </li></ul><ul><li>Persuade </li></ul><ul><li>Present </li></ul><ul><li>Communicate articulately </li></ul><ul><li>Listen actively </li></ul><ul><li>Interpret and consolidate data </li></ul><ul><li>IT literate </li></ul><ul><li>Work independently and cohesively </li></ul><ul><li>Accuracy </li></ul><ul><li>Quality </li></ul>
  13. 13. <ul><li>Team player (cross-functionally) </li></ul><ul><li>Calm under pressure </li></ul><ul><li>Interactive </li></ul><ul><li>Open to change </li></ul><ul><li>Adaptable </li></ul><ul><li>Self motivated </li></ul><ul><li>Ethical </li></ul><ul><li>Willing to learn </li></ul><ul><li>Enthusiastic </li></ul><ul><li>Assertive and confident </li></ul><ul><li>Respond effectively to challenges of opinion </li></ul><ul><li>Multi-culturally aware </li></ul>
  14. 14. <ul><li>How long should the drug effect last? </li></ul><ul><li>What will the dose strength and dosing frequency be? </li></ul><ul><li>Will a pharmacokinetic study be necessary? </li></ul><ul><li>  </li></ul><ul><li>Will a geriatric population have to be considered? </li></ul>
  15. 15. <ul><li>1.Developing a draft package insert: </li></ul><ul><li>  </li></ul><ul><li>Team defines specific claims and considers final dosage form and packaging. </li></ul><ul><li>  </li></ul><ul><li>Re evaluating draft package insert after each clinical study </li></ul><ul><li>  </li></ul><ul><li>Stopping the development program if key claims cannot be realized </li></ul>
  16. 16. <ul><li>2. Getting buy – in to the claims: </li></ul><ul><li>Identifying company’s internal stakeholders, to approve financial information to generate marketing claims. </li></ul><ul><li>The team seek out data via and market research to provide compelling information for management. </li></ul><ul><li>  </li></ul><ul><li>Developing advertising copy, which provides claim positioning. </li></ul><ul><li>Testing the advertising copy with external customers: </li></ul><ul><li>Patients. </li></ul><ul><li>Healthcare professionals. </li></ul>
  17. 17. <ul><li>3. Designing the clinical trials: </li></ul><ul><li>Team identifies clinical endpoints to deliver claims and proceed to design the pivotal work. </li></ul><ul><li>Team can address questions as: </li></ul><ul><li>What data are needed to make decisions ? </li></ul><ul><li>Which clinical endpoints require validation ? </li></ul>
  18. 18. <ul><li>Team can assess: </li></ul><ul><li>Drug drug interaction & organ impairment, </li></ul><ul><li>metabolism pharmacokinetic and </li></ul><ul><li>bioequivalence–the program will need. </li></ul>
  19. 19. <ul><li>Team members should develop questions for meeting. </li></ul><ul><li>Questions regarding </li></ul><ul><li>Any toxicology program appropriate to support human dosing? </li></ul><ul><li>Use of positive controls? </li></ul><ul><li>Go/no-go decisions should be built into each clinical trial to avoid unnecessary expense. </li></ul>
  20. 20. <ul><li>It is important to balance continuity with flexibility so that the project team is not pulled back and forth. </li></ul><ul><li>The plan needs to be flexible enough to be adapted as the team learns more about the product. </li></ul><ul><li>Plan’s serves as a framework while evaluating the change’s impact on resources, timing and market potential. </li></ul>
  21. 21. <ul><li>Team should not try to prevent change but should control it to the project’s advantage. </li></ul><ul><li>Too much change will be disruptive, but lack of change may lead to suboptimal market performance. </li></ul>

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