Clinical Trials Science: Drug Safety and Pharmaco-Vigilance

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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. The core curriculum is specifically designed to be broad enough in its scope to prepare students to work in a variety of job roles related to clinical trials. The content of the core includes the design, initiation, and monitoring of clinical drug trials, federal and international regulations governing drug development, ethics in clinical trials, and a graduate project individualized to the students interest and job responsibilities.

Courses include: * Multiple Analyses in Clinical Trials or
* Data Interpretation
* Overview of Disease Processes and Treatment
* Adverse Event Reporting & Postmarketing Activities
* Principles of Pharmacovigilance: Regulations & Drug Safety Reporting
* Risk Management Tools
* Pharmacoepidemiology
* Signal Detection & Quantifying Risk
* Clinical Pharmacology
* Analyzing Clinical Data for Adverse Events (Elective)

* Bachelors degree or higher with a minimum GPA of 3.0. * Completed application form * Two letters of recommendation from individuals who can assess your professional ability and potential for successful graduate program study. * A 250 word statement stating your short-term and long-term career goals. Attach as a supporting document to your online application. * $65.00 application fee (non-refundable). * Official transcript from highest degree attained. * Resume indicating employment and educational background. Attach as supporting document to your online application. * Credential evaluation: Applicants who have attended an educational institution in a foreign country are required to have their transcript(s) evaluated by a transcript evaluation service. * Passing TOEFL test score for individuals who have a foreign degree from countires where English is not an offcial language.Official electronic TOEFL reports should be sent from vendor directly to Rutgers School of Health Related Profession English Language Requirements TOEFL iBT® test: 79

If you are pursuing a master's degree or professional, terminal degree, Rutgers can help you find fellowships and scholarships to support your advanced study.

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