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CLINICAL TRIALS MANAGEMENT & RECRUITMENT SCIENCES SPECIALIZATION TRACK

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, study monitoring for compliance, facilitating proper data collection, and preparing for a study audit, conducted in an ethical manner are all essential skills required of persons working in clinical research.  In addition, students in this track will be well positioned for a career in clinical research monitoring as well as be on the forefront of the developing strategies for a new and growing pharma job role, the Patient Recruitment Specialist. Click Here For Courses

 

DRUG SAFETY &  PHARMACOVIGILANCE

There is a benefit:risk 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.  But many safety issues first become apparent only after large-scale clinical trials are conducted.  As drug recalls grow there has been a greater emphasis put on identifying signals throughout the development process and into the post-marketing phase.  Both the US Food & Drug Administration and the European Medicines Agency have developed offices of drug safety and surveillance.  There is also a new regulatory environment related to reporting adverse events as well as new quantitative methods for developing signal detection. The track is designed to educate students to recognize, quantify, analyze, and communicate the beneftis and risks associated with drug and related products. Although this specialization track is suggested for the individual who has a clinical background in medicine, nursing, pharmacy, or allied health, this is not a requirement.  Click Here For Courses

 

CLINICAL TRIAL INFORMATICS

Through its Critical Path Initiative, the FDA, as well as international regulatory agencies, have made modernizing its Biomedical and Bioinformatics infrastructure a priority.  Effective management of drug and device product information is essential to enhancing the FDA regulatory decision making.  In addition, an efficient bioinformatics system will enable faster identification of adverse reactions and improve reporting to the stakeholders.  Clinical Data Management professionals are needed to design and use software involved in data capture and mining, subject recruitment and retention efforts, to analyze databases for drug efficacy and adverse events, and to assist the team members in utilizing the appropriate research designs from a data collection approach.  This track prepares individuals to take on these challenges so that there is a seamless flow of information from the research site to the biopharmaceutical industry and then to the appropriate regulatory agency. Click Here for Courses

 

REGULATORY AFFAIRS

The laws and guidelines that regulate the research, marketing approval, manufacturing and advertising of drugs, biologics, and medical devices are often complex and change often. Several new recommendations may significantly broaden the Food and Drug Administration as well as International Regulatory Agencies 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.  Click Here for Courses

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