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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. 

 

Required

BPHE 5510P Overview of Disease Processes and Treatment 3 cr

BPHE  5521P

Regulatory and Ethical Requirements in Clinical Investigation

3 cr

BPHE 6985P

Principles of Subject Recruitment and Retention

3 cr

Approved Electives

Electives-choose Two (with Advisement)

BINF 5075E

Biomedical Bioinformatics for Clinical Trial Management

3 cr

BPHE 6352P Applied Clinical Trials & GCP 3 cr

BPHE  6510P

Clinical Operations

3 cr

 

Courses from the other Biopharma Certificates may be taken as electives with approval

 

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.

 

Required

BPHE  5310P

Clinical Trials Overview:  Methods and Process

3 cr

BPHE  5521P

Regulatory and Ethical Requirements in Clinical Investigation

3 cr

BPHE  5725P

Adverse Event Reporting & Postmarketing Activities

3 cr

Approved

Electives

Electives-choose Two (with Advisement)

BPHE  5110P

Food and Drug Law

3 cr

BPHE 6200P Concepts of GxPs and Quality Assurance 3 cr
BPHE 6500P Regulatory Requirements for Medical Devices 3 cr

BPHE 6530P

International Regulatory Affairs

3 cr

BPHE 6600P Advertising & Labeling in Marketing Pharmaceuticals 3 cr
BPHE 6800P Regulatory Writing for Submission & Publication 3 cr

 

Courses from the other Biopharma Certificates may be taken as electives with approval

 

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.

 

Required

BINF  5005E

Healthcare Information Systems  

3 cr

BINF  5075E

Biomedical Informatics for Clinical Trials Management

3 cr

BPHE 5800 Using Computerized Systems in clinical Research & Risk Management 3 cr

Approved Electives

Electives-choose Two (with Advisement)

BINF 5210E SAS Application in Biomedical & Clinical Research 3 cr
BINF 5311E Introduction to Electronic Health Records 3 cr
BINF 5312E Health Information Processing in XML 3 cr

BPHE  5310P

Clinical Trials Overview:  Methods and Process

3 cr

BPHE  5521P

Regulatory and Ethical Requirements in Clinical Investigation

3 cr

BPHE 6352P Applied Clinical Trials & GCP 3 cr
 

 

Courses from the other Biopharma Certificates may be taken as electives with approval

 

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.

 

Required

   
BPHE  5521P Regulatory & Ethical Requirements in Clinical Investigation 3 cr

BPHE  5725P

Adverse Event Reporting & Postmarketing Activities

3 cr

BPHE 5780P Principles of Pharmacovigliance, Regulations, & Drug Safety Reporting 3 cr

Approved Electives

Electives-choose Two (with Advisement)

 
BPHE 5510P Overview of Disease Processes and Treatment 3 cr
BPHE 6000P Risk Management Tools 3 cr
BPHE 7510P Clinical Pharmacology or NUTR 7510 Nutrition & Pharmacology 3 cr
BPHE 7600P Analyzing Clinical Data To Determine Adverse Events 3 cr

 

 

 

 

 

 

 

 

 

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