Regulatory Affairs

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Text of Regulatory Affairs

  • 1. By: Shabeena Zaidi


  • a dynamic and challenging profession
  • gives strategic and technical advice for product development,
  • contributes commercially and scientifically to the success of a development programme andcompany.
  • ensures public health by to controlling safety and efficacy of products.


  • The Regulatory Affairs professionals keep track of the changing legislation inthe regions in which the company distributes its products.
  • They advise on :
    • Legal and scientific restraints and requirements,
    • Collect, collate, and
    • Evaluate the scientific data that their R&D Dept. generates.


  • Present registration documents to regulatory agencies, and carry out negotiations necessary to obtainmarketing authorisation for products.
  • Give strategic and technical advicein their companies, right from the beginning of the development of a product.
  • Their RA dept must be aware of the regulatory requirements in all the companys export markets.


  • Reduction of the timetaken to reach market is critical to products and the companys success ensured by R.A.
  • 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.
  • A good Regulatory Affairs professional will help to maximise the cost-effective use of the companys resources.
  • This Dept. is first point of contact between the government authorities and the company. Officials respondbetter to a company whose representatives are scientifically accurate and knowledgeable.


  • The Regulatory Affairs Professionals Society, RAPS,
  • The Organisation for Professionals in Regulatory Affairs, TOPRA,
  • Drug Information Association (DIA), the Food and
  • Drug Law Institute (FDLI) and international


  • They offer:
  • Education and training,
  • Professional development,
  • Competence certification
  • Codes of ethics in RA.


  • Founded in 1976.
  • International membership organization of regulatory professionals
  • RAPS work in all areas of the healthcare product lifecycle,
  • Ensures thatproducts are safe and effective.
  • Provides education, training, certification, research,publicationsand career development.
  • Website[email_address]

9. 10.

  • Pharmaceuticals
  • Medical devices
  • In vitro diagnostics
  • Biologics and biotechnology
  • Nutritional products and
  • Cosmetics


  • They come in contact withpharmacologists, toxicologists, analytical chemists, pharmacists, medical doctors and statisticians.
  • Assimilate information by such specialists.
  • Present that information to regulatory authorities.
  • Feed-back their opinions to the rest of the company.


  • Influence
  • Negotiate
  • Persuade
  • Present
  • Communicate articulately
  • Listen actively
  • Interpret and consolidate data
  • IT literate
  • Work independently and cohesively
  • Accuracy
  • Quality


  • Team player (cross-functionally)
  • Calm under pressure
  • Interactive
  • Open to change
  • Adaptable
  • Self motivated
  • Ethical
  • Willing to learn
  • Enthusiastic
  • Assertive and confident
  • Respond effectively to challenges of opinion
  • Multi-culturally aware


  • How long should the drug effect last?
  • What will the dose strength and dosing frequency be?
  • Will a pharmacokinetic study be necessary?
  • Will a geriatric population have to be considered?


  • 1.Developing a draft package insert:
  • Teamdefines specific claims andconsiders final dosage form and packaging.
  • Re evaluating draft package insertafter each clinical study
  • Stopping the development program if key claims cannot be realized


  • 2. Getting buy in to the claims:
  • Identifying companys internal stakeholders, to approve financial information to generate marketing claims.
  • The team seek outdata viaand market research to provide compelling information for management.
  • Developing advertising copy, which provides claim positioning.
  • Testing the advertisingcopy with external customers:
  • Patients.
  • Healthcare professionals.


  • 3. Designing the clinical trials:
  • Teamidentifiesclinical endpoints to deliver claims and proceed to design the pivotal work.
  • Team can address questions as:
  • What data are needed to make decisions ?
  • Which clinical endpoints require validation ?


  • Team can assess:
  • Drug drug interaction & organ impairment,
  • metabolism pharmacokinetic and
  • bioequivalencethe program will need.


  • Team members should develop questions for meeting.
  • Questions regarding
  • Anytoxicology program appropriate to support human dosing?
  • Use ofpositive controls?
  • Go/no-go decisions should be built into each clinical trial to avoid unnecessary expense.


  • It is important to balance continuity with flexibility so that the project team is not pulled back and forth.
  • The plan needs to be flexible enough to be adapted as the team learns more about the product.
  • Plans serves as a framework while evaluating the changes impact on resources, timing and market potential.


  • Team should not try to prevent change but should control it to the projects advantage.
  • Too much change will be disruptive, but lack of change may lead to suboptimal market performance.