In today’s biopharmaceutical business, medical affairs are becoming increasingly important in giving scientific and medical information to hospital consultants, key opinion leaders (KOLs), regulatory bodies, and healthcare professionals on the value and proper use of products. The Medical Affairs team is made up of seasoned physicians who are supported by pharmacologists who are experts in almost every aspect of medicine’s therapeutics.
To be able to apply safety principles into product designs, each member of the team must be aware of the severe safety rules. Medical Science Liaisons (MSL), Medical Communications/Publications, Medical Education, and Medical Information are among the members of the team. The Medical Affairs (MA) function’s goal is to educate stakeholders by providing product-related information that is accurate, full, and unbiased.
MA practicalcme activities are not intended to “promote” a product or replace sales and marketing techniques and must adhere to federal, industry, and corporate regulatory policies. All items released as a result of MA’s actions should be checked for conformity with existing regulations. The creation of new pharmaceuticals requires a lot of money from pharmaceutical corporations.
They spend a lot of time looking at medical items and therapies that might be used in the future. Often, the commitment is made over a long period, and then the study indication is submitted for marketing clearance. These indications are gained in relatively small markets, and bigger markets will be added after clearance.
Medical affairs can cover the demand for studies undertaken after approval, notwithstanding the variations between post-marketing studies and clinical registration trials. This is another instance in which medical issues play a crucial influence. Sales teams may be in a better position to market the new product to doctors in a more professional manner, but they frequently require assistance in doing so.
Medical Affair Roles
For sales, marketing, and research, Medical Affairs serves as the key point of contact for several therapeutic areas. Medical Affairs collaborates closely with several other departments. The following are the responsibilities of Medical Affairs:
- Product profiles, monographs, package inserts/patient information leaflets, pharmacology, and toxicity parts of registration dossiers with continual revisions are all subject to scientific development and review.
- Clinical Development Plan Preparation
- For the formulation of the research protocol, including therapeutic and scientific content
- Creating and carrying out pharmacoeconomic research
- Regulatory reports, articles, abstracts, posters, and other scientific materials are reviewed and approved.
For Medical Monitoring and Safety Management, Medical Affairs practicalcme collaborates with the Pharmacovigilance team on reported SAEs and other pharmacovigilance data for current pharmaceuticals on the market, as well as early data for products in development. Regularly, Medical Affairs works with the Sponsor, Investigation Sites, and Project Management team to address any medical or safety concerns.
- SOPs for medical and safety preparation and maintenance
- SAE data, including CIOMS reports, is received, processed, and archived.
- Creating and maintaining a safety database
- SAE reconciliation requires medical assistance.
- Review of CRFs by a physician
- Using MedDRA, review, and approval of medical coding
- Examining the safety parameters as well as the alert reports
- Review and evaluation of reports of significant adverse events by a physician
- Prescribers’ questions concerning the product are answered.