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Medical Affairs Services: Role in Planning of New Pharmaceutical Product Launch

Leading pharmaceutical and biotech companies are increasingly under pressure to deliver effective new products in shorter time frames while minimizing the development costs. The structure, activities, resources of new product, planning regarding launch and successful commercialization of new product are main areas of focus of for medical affairs department in all the pharmaceutical companies. Many critical activities take place well in advance of the actual launch of a new product. Each of these activities is time bound and has a set of objectives. The activities are divided into prelaunch, launch, and post launch activities.

During the time of launch, the medical affairs services team plays a dual role. Internally, it is responsible for training of medical representatives, approving promotional material and medical inputs. Externally, it acts as the face of the organization by exposing higher number of physicians to the product, addressing queries of physicians on usage of the medicine and participating in physician meetings. In the post launch phase, the function of medical affairs team is to update physicians on emerging information, answer queries on the drug's safety and efficacy profile. In addition, currently, medical affairs services play an important role in partnering with physicians on investigator initiated research and epidemiological studies which is the real need in pharmaceutical and biotech companies.

Medical affairs services play critical role between a pharmaceutical company and external stakeholders. External stakeholders include regulatory agencies, physicians, hospital administrators and patient groups. To maximize the value and effectiveness of medical affairs, this department should be formed about one to two years in advance of product launch. This period will allow a medical affairs team to become familiar with the product, understand related issues, and become experts in the group’s wide variety of roles and responsibilities. Understanding the capabilities and functions of medical affairs and the timing for when their functions are needed is a critical component for preparation and execution of a successful drug product launch.

The role of medical affairs services include highlighting the advantages of the new medicine, providing inputs on the exact medical positioning of the product, and discussing the science related to the medicine. These discussions can be either one-to-one with practicing physicians or in the form of advisory boards. The boards must include physicians of highest repute such as academicians, those having interest in original research and publications in their respective therapy area. Medical advisors often coordinate these programs and share new data available for different indications.

A medical affairs department should have current policies and procedures to train and support a culture of compliance among the employees and organizational leaders. The department should have policies that address the dissemination of off-label literature, responding to solicited and unsolicited requests for information regarding off-label usage grant funding, medical letters, screening consultants, disclosure of payments to healthcare professionals, and any other activity that falls under the purview of the medical affairs department. As the law changes, policies and procedures also should be updated, and employees affected by such changes should be trained accordingly. Otherwise policies and procedures that are nothing more than dust collectors on a book shelf for some companies will find themselves incompetent to defend the organization in the event of a FDA investigation.

WorkSure Medical Affairs company help industries to update their knowledge regarding changing policies and procedures. The team has the capability to help in preparation for each component of new product launch. Also they help in execution of successful product launch.


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