By: Shabeena Zaidi

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a dynamic and challenging profession

gives strategic and technical advice for product development,

contributes commercially and scientifically to the success of a development programme and company.

ensures public health by to controlling safety and efficacy of products.

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The Regulatory Affairs professionals keep track of the changing legislation in the 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.

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• Present registration documents to regulatory agencies, and carry out negotiations necessary to obtain marketing authorisation for products.

• Give strategic and technical advice in 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 company’s export markets.

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• Reduction of the time taken to reach market is critical to product’s and the company’s 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 company’s resources.

• 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.

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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 international6

They offer:

Education and training,

Professional development,

Competence certification

Codes of ethics in RA.

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Founded in 1976. 

International membership organization of regulatory professionals

RAPS work in all areas of the healthcare product lifecycle,

Ensures that products are safe and effective.

Provides education, training, certification, research, publications and career development.

Website raps@raps.org8

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Pharmaceuticals

Medical devices

In vitro diagnostics

Biologics and biotechnology

Nutritional products and

Cosmetics

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They come in contact with pharmacologists, 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.

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

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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

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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?

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1.Developing a draft package insert: Team defines specific claims and considers final

dosage form and packaging. Re evaluating draft package insert after each clinical

study Stopping the development program if key claims

cannot be realized

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2. Getting buy – in to the claims:

Identifying company’s internal stakeholders, to approve financial information to generate marketing claims.

The team seek out data via and market research to provide compelling information for management.

  Developing advertising copy, which provides claim

positioning.

Testing the advertising copy with external customers:

• Patients.• Healthcare professionals. 16

3. Designing the clinical trials:

Team identifies clinical 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 ?17

Team can assess:

• Drug drug interaction & organ impairment,

• metabolism pharmacokinetic and

• bioequivalence–the program will need.

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Team members should develop questions for meeting.

Questions regarding

Any toxicology program appropriate to support human dosing?

Use of positive controls?

Go/no-go decisions should be built into each clinical trial to avoid unnecessary expense.

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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.

Plan’s serves as a framework while evaluating the change’s impact on resources, timing and market potential.

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Team should not try to prevent change but should control it to the project’s advantage.

Too much change will be disruptive, but lack of change may lead to suboptimal market performance.

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