Category Archives: Uncategorized

The Importance of Standardization in Medical Affairs

The medical affairs function has two primary goals : (1) educate and disseminate medical information and (2) generate new data. Medical affairs is involved in a variety of important decisions related to pharmacovigilance, health econ omics research and designing clinical trials among other functions . The value that medical affairs contributes within the medical community can be seen on a daily basis. Indeed, health care providers (HCPs) are increasingly relying more on the “medical arm” of the industry for ed ucation vs. the sales team. To fully understand the background and reason for this, it is important to provide a brief review of som e historic industry milestones over the last decade.

The Board Certified Medical Affairs Specialist Program (BCMAS) comes to Rutgers University providing a new path forward for scientific and clinical professionals looking to work within the pharmaceutical industry

Rutgers iJOBS is excited to have biomedical graduate students and postdoctoral fellows completing the Board Certification in Medical Affairs Specialist program. iJOBS is funded by the NIH Broadening Experiences in Scientific Training (BEST) initiative with the goal of exposing PhD students and postdocs to careers outside of academia so they can make informed decisions about their futures. Many of our iJOBS trainees have expressed interest in a career in Medical Affairs within the pharmaceutical industry and the BCMAS program is a systematic mechanism for training scientific and clinical professionals in the topics related to this field.

Off label drug promotion – change may be coming soon

A few weeks ago, the Food and Drug Administration (FDA), released a report establishing a final rule amending regulatory definitions of what is considered “intended use” for drugs which had originally required drug companies to include labeling for unapproved uses the drug company knew about. The FDA revised this in January stating that if a drug company has plans to promote a drug off-label based on the “totality of the evidence” then similar labeling was required.