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Text of Regulatory Affairs
- 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.
- Legal and scientific restraints and requirements,
- 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,http://www.raps.org
- The Organisation for Professionals in Regulatory Affairs, TOPRA,http://www.topra.org
- Drug Information Association (DIA), the Food and
- Drug Law Institute (FDLI) and international
- Professional development,
- 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.
- Biologics and biotechnology
- 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.
- Interpret and consolidate data
- Work independently and cohesively
- Team player (cross-functionally)
- Respond effectively to challenges of opinion
- 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:
- 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 ?
- Drug drug interaction & organ impairment,
- metabolism pharmacokinetic and
- bioequivalencethe program will need.
- Team members should develop questions for meeting.
- Anytoxicology program appropriate to support human dosing?
- 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.