Clinical Trials Management & Recruitment Sciences
This specialization track presents the knowledge and skills necessary for effective clinical trial management from the sponsors’ perspective as well as that of the individual study sites. Protocol development, IRB submissions, managing study budgets, facilitating proper data collection, and preparing for a study audit, conducted in an ethical manner are all essential skill sets required of persons working in clinical research. In addition, students in this track will be on the forefront of developing strategies for a new and growing pharma job role, the Patient Recruitment Specialist.
The laws and guidelines that regulate the research, marketing approval, manufacturing and advertising of drugs, biologics, and medical devices are often complex and change frequently. Several new recommendations submitted to Congress may significantly broaden the Food and Drug Administration’s ability to monitor the safety of drugs and devices and to improve the agency’s ability to respond to emergent drug and device safety issues. The material offered in this track prepares the student to conduct essential filings with regulatory agencies and to have a thorough understanding of law, policy, and business governing bringing product to market.
Drug Safety & Pharmacovigilance
There is a risk: benefit ratio for every drug, biologic and medical device. Some of the risks are known early in the development phase and can be predicted by pre-clinical studies. However, many safety issues first come to light only after large-scale clinical trials are conducted in the post-marketing phase of development. Some issues are related to a drug’s mechanism of action but others may be related to manufacturing issues or problems with product labeling and information leaflets. As drug recalls grow there has been a greater emphasis put on identifying signals both in the clinical phase of study and after the product has been released on the market.
This specialization track educates the students on how to recognize, quantify, analyze, and communicate the benefits and risks associated with drug and related products. The Certificate in Drug Safety and Pharmacovigilance will have a similar goal but will be primarily intended for the student currently working within the profession or for the student who wishes to pursue work on the regulatory aspects of pharmacovigilance and not signal detection.
This specialization track teaches the knowledge and skills necessary to enter various facets of medical affairs which is a high growth area in the biopharmaceutical industry. Positions in this area are necessary to manage the growing vital sector in today’s industry in providing key opinion leaders, regulatory agencies and healthcare professionals with scientific and medical information relating to the value and correct usage of the products. Medical affairs personnel strive for the highest scientific integrity so as to produce successful clinical trials and supply the greatest support for the market. Medical affairs groups perform many activities often overlapping with sales, Medical marketing, clinical growth, and customer service. In parallel, they serve as the bridge between the company’s internal stakeholders, especially clinical development and the company’s external stakeholders. Medical Affairs’ focus on generating meaningful evidence, strategic engagement of key opinion leaders and the dissemination of relevant scientific information makes it paramount for them to ensure their knowledge and skills are well supported by a formidable education system.
This specialization track educates the student on the role of medical affairs in commercialization, in particular, to develop research hypotheses and designs for medical affairs studies, disseminate study results in an effective and efficient way to various stakeholders, design communication strategies, develop brand strategies, understand stakeholder needs (e.g., regulatory affairs, market access) and develop strategies for win-win partnerships, address challenges that medical affairs faces in commercialization, and interpret regulatory and clinical guidelines.