Medical Affairs

Adverse event

An unfavorable medical occurrence in a patient or clinical trial subject after they’ve been administered a medical product. The event may or may not be related to the medication.

Clinical Liaison

Another term for Medical Science Liaison or MSL.

Field medical team

A field medical team is made up of Medical Science Liaisons (MSLs) who engage with healthcare professionals (HCPs) and other key stakeholders such as key opinion leaders (KOLs) through face-to-face meetings. The aim is to share, educate, and discuss scientific and clinical data. There are also virtual MSLs who are specially trained to deliver content via phone or video conferencing and, more commonly now, hybrid MSLs who are skilled at communicating via face-to-face, virtual and digital channels, depending on HCP preference.

Key opinion leaders (KOLs)

A KOL is an experienced or high-profile physician, usually specializing in a particular therapeutic area, who is well respected by others in their field. Medical Affairs teams and Medical Science Liaisons (MSLs) will build relationships with KOLs to gather valuable product and therapy area insights.  KOLs often play a key role in educating the wider medical community on product information, data, and clinical science.

Medical Affairs

In general, a Medical Affairs team is responsible for providing unbiased clinical and scientific communication and information about medicines and healthcare products to patients, members of the public, physicians, KOLs, and the wider network of healthcare stakeholders. A Medical Affairs team is committed to patient safety and so will also manage the intake and management of adverse events and product quality complaints. Medical Affairs is key function within biotechnology, pharmaceutical and medical device companies, which operates independent of the Commercial organization.

At Ashfield Engage, Medical Affairs teams include Medical Science Liaisons (MSLs) and Medical Information Specialists.

Medical Information call center / contact center

Medical Information Specialists work from a medical information call center (or medical contact center) to respond to inquiries from healthcare professionals, consumers, patients, caregivers, and others. They handle requests for general, medical or technical information, identify and report product quality complaints and adverse events, and support clinical trials. Interactions with customers often occur via several channels including – but not limited to – phone, email, fax, mail, live chat, SMS and chatbot/artificial intelligence.

Medical information

Medical Information Specialists provide HCPs and patients with accurate, reliable information on medications and how to use them effectively and safely. Information provided is also unbiased and in compliance with appropriate guidelines and regulations.

Medical Science Liaison (MSL)

Medical Science Liaisons (sometimes just called Medical or Clinical Liaisons) are part of the Medical Affairs team and work on behalf of biotechnology, pharmaceutical or medical device companies to build relationships and educate on complex scientific and medical information to a wide range of stakeholders, including HCPs, payers, and Key Opinion Leaders. MSLs also build relationships with the medical and scientific community to gather important insights that help inform medical strategy.

Product quality complaint

A complaint about a medical product, delivery device or packaging. Examples may include a broken syringe or damaged tablets.

Risk Evaluation and Mitigation Strategy (REMS)

A Risk Evaluation and Mitigation Strategy is a U.S. Food and Drug Administration (FDA) drug-safety program that helps ensure the benefits of a particular medication outweigh the potential risks.

Ashfield Engage supports REMS programs by, for example, screening for REMS adherence through patient and pharmacy counseling and training, as well as managing REMS registration and outreach to ensure compliance.