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April 6, 2022

FAQs about
Medical Information

Frequently Asked Questions about Medical Information

1. What is Medical Information?

The goal of medical information is to disseminate fair and balanced medical information in response to unsolicited questions from requestors in a timely manner following the company procedures.

2. Why does a company need a Medical information Department?

Regulatory agencies require that the marketing authorization holder shall establish, within his undertaking, a scientific service in charge of information about the medicinal products it places on the market.

3. What is the Medical Information Call Center (MICC)?

Medical Information Call Center handles medical inquiries, identify adverse events (AEs)/Incident reporting, and product quality complaints (PQCs).

4. What are medical information platforms?

Medical information platforms are automated systems to ensure timely delivery and track and record of medical/safety information. For example: Ring Central, IRMS, and Veeva.

5. What are the medical information requirements during clinical trials?

The scope of medical information services with respect to clinical trials is very limited. A Medical Information Team serves as a link between the investigators, sponsors, and subjects to ensure appropriate reporting of safety issues and raising of queries and warm transfer of medical information–related questions to appropriate parties.

6. Is medical information required globally?

The goal of medical information is to disseminate fair and balanced medical information in response to unsolicited questions from requestors in a timely manner. This is consistent across all countries and regions.

7. Are the regulatory requirements for medical information same globally?

Regulations vary locally and by country. For example: Canadian regulations require someone to be present locally in case a caller requests to route his/her call in Canada.

8. What is interactive voice response system (IVRs)?

IVRs are telehealth application that provides automated access to call centers.

9. What is a Standard Response Letter (SRL) or Medical Information Letter?

A Standard Response Letter is a formal pre-written and approved response that a Medical Information Team prepares for unsolicited commonly asked questions.

10. Who are Medical Science Liaisons (MSLs)?

Medical Science Liaison (MSL) is a pertinent role within the Medical Affairs that are provided by pharmaceutical companies. MSLs concentrate on specific therapeutic areas (across a vast set of therapeutic areas that include but are not limited to hematology, cardiology, and central nervous system). MSLs have an extensive medical training in these advanced therapeutic areas. MSLs serve as the key points of contact for physicians and healthcare professionals (HCPs) at major academic institutions and clinics.
Go back to Medical Information

Published on: April 04, 2022

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    Top 10 pharmaceutical company with operations in the EU and US
  • AVP, Pharmacovigilance
    We appreciate APCER for its efficiency in responding to matters that they get even at the eleventh hour. Working with APCER has made compliance a lot easier.
    AVP, Pharmacovigilance
    US-based pharmaceutical company
  • Senior Director
    We are thankful to team APCER for bringing in strong practices & helping inspection readiness in our pharmacovigilance framework which led to successful FDA audits.
    Senior Director
    US-based pharmaceutical company

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