Saturday, 25 August 2012

Medical Affairs

Medical Affairs identify and address the medical needs associated with products, therapies and disease states thereby driving improvement in patient outcomes in line with commercial objectives. Medical Affairs came into existence in pharmaceutical and biotech industries to aid interactions between health care professionals and company representatives. However with time, the role of Medical Affairs has transformed from being a traditional support function to an equal partner role. Besides providing scientific and medical information to healthcare professionals, key opinion leaders and regulatory bodies, Medical Affairs plays an important role in promoting proper and ethical use of a company’s products and therapies for the benefit of mankind. Thus, Medical Affairs function supplements the work of Research & Development and also enhances sales and marketing efforts. By and large Medical Affairs operates as the medical conscience of the company and contributes to its growth and success. Strengthened regulatory and public scrutiny, growing competition and swelling budget for drug development has made the Medical Affairs role even more crucial to pharmaceutical companies' success. Nevertheless the companies face challenge in managing the Medical department due to high manpower costs.

WorkSure™ Medical Affairs provides consulting services to sales & marketing, clinical trials, pharmacovigilance, regulatory and legal departments. We at WorkSure are proactive at all levels, identify novel approaches and establish dedicated boundary-spanning teams for different companies. We work at all stages in the life cycle of a biopharmaceutical product/device. The various Medical Affairs functions that we offer are:

Medico- Marketing & business development
The complexity of medical marketing is one of the important aspects of a business proposal in the pharmaceutical industry. Promotion refers to all informational and convincing activities by company and distributors, the effect of which is to bring about the prescription, supply, purchase and/or use of medicinal drugs. Medical Affairs review external communications for ethical and credible promotion of all brands. Across product life cycle, the Medical Affairs provide guidance on therapy positioning in all marketing and promotional campaigns and keep a close watch on the approvals. Medical Affair activities ensure appropriate market conditioning which has a real impact on increasing product awareness.

KOL management & interfacing responsibilities
The Key opinion leader (KOL) management should be aligned with both scientific and commercial perspectives which require optimal organizational structure. Harmonizing KOL activity is increasingly crucial for both compliance and effectiveness. The communication of meaningful information like crafting scientific exchange tools and resources for continued medical education on disease state, current therapeutics, and patient care gaps is the underpinning of ongoing interaction between KOLs and Medical Affairs function.

Clinical research & regulatory activities
Medical Affairs team works closely with the clinical development team for planning and organizing clinical trials. They support clinical development plan, protocol development, investigator selection and meetings, ongoing data maintenance and management, statistical analysis & interpretation, report writing activities etc. They are involved in pharmacovigilance, regulatory support and post marketing safety and surveillance studies. Medical Affairs professionals evaluate and conduct pharmacoeconomic studies to facilitate cost effective health care decision making. The Medical Affairs department plays a central role in strategizing regular audits for checking compliance and quality assurance.
Medical education and training
The role of the Medical Affairs function is to educate health care professionals through the delivery of precise, complete and impartial information that supports a product. External education activities include CMEs, seminars, small group meetings, updates and conferences etc. A sales representative also plays a reasonable role in providing customers i.e. doctors with recent updated information about the products and guidelines. So, sales representatives are also required to be trained to stay abreast with the latest information on the products, and also industry regulations.

Medical communications
Field of medicine is ever-changing with constant flow of new knowledge and information. One of the main responsibilities is supplying the medical profession with the best available information pertaining to their area of interest. Medical writing has established as an important function of Medical Affairs, because it requires specialized knowledge and skills to write scientific documents which are well-structured, and presented in a clear and lucid manner.


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