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Medical Affairs Role in Pharmaceutical Companies

The Medical affairs groups are a growing vital sector in today's bio pharmaceutical industry in providing hospital consultants, key opinion leaders (KOL's), regulatory agencies and healthcare professionals with scientific and medical information relating to the value and correct usage of the products.

Medical affairs personnel strive for the highest scientific integrity so as to produce successful clinical trials and supply the greatest support for the market. Medical affairs groups perform many activities often overlapping with sales, Medical marketing, clinical growth, and customer service.

Sales groups may be ill-positioned to accurately present the new product to physicians and quite often need help in making more expert presentations. Medical affairs groups might help in developing appropriate positioning for new releases and help to leveraging the newer indications to come.

Pharmaceutical companies spend tremendous resources for development of new drug treatments. A great deal of time is spent in doing research on potential health-related products and medicines.

While considering the distinctions between post marketing scientific tests and clinical registration demos, medical affairs can fill the requirement for the studies done post approval.

Medical Affairs Role in Functional Areas:

Medical Affairs acts as the central focal point for different therapeutic areas of sales, marketing and research. Medical Affairs work closely with various functional departments such as:

 

Medical Writing

 

Scientific Development and Reviewing connected with Product profiles, monographs, package deal insert/ patient information booklet, pharmacology and toxicology parts of registration dossiers with constant updates.

 

 

Preparation of Professional medical Development Plan

Providing therapeutic and scientific content for development of study standard protocol

Designing and implementation connected with pharmacoeconomic studies

 

Reviewing along with approval of regulatory submission, manuscripts, abstracts, posters as well as other scientific documents.

 

Medical Monitoring:

Medical affairs are the Primary medical contact towards the sponsor, investigative website, and project group.

Medical Affairs supports the look, conduct and evaluation of clinical research and involves continuous data maintenance as well as management.

Involves in talk on study feasibility together with Key Opinion Leaders as well as other potential investigators with regards to possible logistical requirements of the study protocol as well as responds to subject eligibility and disengagement questions.

A Medical affairs team is usually responsible for Medical Monitoring:

Medical affairs are the Primary medical contact towards the sponsor, investigative website, and project group.

Medical Affairs supports the look, conduct and evaluation of clinical research and involves continuous data maintenance as well as management.

Involves in talk on study feasibility together with Key Opinion Leaders as well as other potential investigators with regards to possible logistical requirements of the study protocol as well as responds to subject eligibility and disengagement questions.

A Medical affairs team is usually responsible for clinical trials Protocol and study linked training for researchers and site personnel.

 

Medico Marketing:

 

During Pre launch cycle of drug the actual Medical Affairs team will establish a KOL strategy for this product based upon prescriber's interest in research and education for your given indication. Then MA departments will target prospective KOLs and connect to them regarding the actual science behind the revolutionary product, ongoing trials like the balanced information regarding both positive along with negative results. Also discuss the important thing data from healthcare meetings and summaries of changes to apply the guidelines. In addition it will conduct additional education activities of Sales/Marketing individuals to raise awareness of the disease state, current therapeutics, and current gaps in sufferer care. Further, the interests of the KOLs will be assessed during discussions to find out the appropriate scientific exchange and any prospective opportunities for potential investigator-initiated trials (IITs).

At the time of product launch MA was responsible in ensuring clear understanding on utilization of the product by the prescribers. They exchange technological information regarding compound-specific characteristics and physician perceptions of the drug profile. In those times MA will perform an evaluation of IIT proposals that might generate a Step IV strategy which will further differentiate the merchandise post-marketing.

 

During the Post-launch period of a drug, MA seeks suggestions from KOLs and along with this, it resolves the queries regarding the product ensuring that they know exactly how you can use the product or service. MA maintains the collection of information regarding the acceptance of the product among prescribers along with issues being confronted by the drug. These valuable data will update marketing work as deemed necessary. Further discussions upon clinical practice roles and potential extra indications with KOL's facilitate the commencement regarding IITs and Step IV studies.

 

Conclusion:

 

Medical Affairs is the majority of credible link with external stakeholders and also play a progressively more important role in communicating the product or service value message to physicians in an objective and ethical manner. They provide assistance in dissemination of technological information regarding current products to regulating agencies and healthcare professionals. Thus Medical Affairs play an important role in establishing appropriate positioning for new items and help to  help leverage the newer indications in the future.

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