BIOPHARMA INITIATIVE CERTIFICATE PROGRAMS*

*Programs award multi-school certificates from the Biopharma Educational Initiative

Certificate and Non- Matriculated Students apply Online HERE

CERTIFICATE IN CLINICAL TRIALS RECRUITMENT SCIENCES

As the number of clinical trials increases globally, so has the competition for study subjects.  This certificate was designed specifically to assist the biopharmaceutical employee to develop and validate strategies for clinical trial subject recruitment and retention.  This 15 credit (5 courses) online program provides students with a solid understanding of the new discipline – Patient Recruitment Science – and prepares them to apply these strategies to reduce drug cycle time. 

CERTIFICATE IN CLINICAL TRIALS REGULATORY AFFAIRS

The laws and regulations related to the development and marketing of drugs, biologics and medical devices are often complex and continually changing.  Regulatory Affairs professionals are needed to interpret these laws both in the US and internationally, file the appropriate documents, and provide strategic and operational guidance in meeting the requirements of global regulatory agencies.  This 15-credit online certificate provides students with a comprehensive review of food, drug, and device law and concepts of quality control and quality assurance to ensure compliance with government regulations.

CERTIFICATE IN CLINICAL TRIALS INFORMATICS

Rapidly expanding research data sets used in clinical trials provide the Biopharma industry with prized information to guide drug development, marketing, and surveillance.  Understanding how to collect and utilize that information through medical bioinformatics is a key skill for the clinical research professional.  This 15-credit online certificate provides students with both the theoretical and practical experience to design data bases for the collection of clinical trial outcome measures and adverse events.  In addition, as a clinical data manager, students will be prepared to make meaningful contributions to trial design based on principles of data collection.

CERTIFICATE IN DRUG SAFETY & PHARMACOVIGILANCE

There is a risk:benefit ratio for every drug, biologic, and medical device.  Some of the risks are known early on during the drug development process, but some risks do not become apparent until after the drug has been marketed.  In either case the drug company must report these risks to the regulatory agencies.  The emphasis of this certificate is placed on the processing and reporting of serious adverse events, understanding global regulations, filing the necessary regulatory documents, answering regulatory aproval queries, and promoting the use of risk mitigation strategies.  Students will be able to assess adverse events according to severity, file all necessary documents to inform the regulatory agencies of adverse events, develop and prepare a Risk Management Minimization System and the European equivalent, and identify post-marketing adverse event data from multiple sources.