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Certificate in Clinical Development and Regulatory Affairs

In response to the increasing demand for trained professionals in the pharmaceutical, biopharmaceutical, and medical device industries, the Center for Continuing Studies at Mercer is offering a comprehensive certificate program in Clinical Development and Regulatory Affairs. All courses in the certificate program are taught by instructors who are highly experienced in their field, as well as guest speakers who bring added expertise to the program.

Upon completion of the certificate program, participants will be able to:

      • Define the roles and responsibilities of sponsor, monitor, and investigator as they relate to the conduct of global clinical trials.

      • Recognize clinical trial documentation differences for biologics, medical devices and pharmaceuticals.

      • Describe differences between regulatory submission requirements of new biologics, medical devices, pharmaceuticals, vaccines.

      • Discuss the impact of FDA regulations and guidance documents, EU directives, EMEA regulations and ICH GCP on clinical development.

      • Describe the elements of a clinical protocol, an informed consent, monitoring visit reports and a corrective and preventative action plan.

Who should attend:

Those with a Bachelor of Arts or Bachelor of Science in-

      • Nursing

      • Pharmacy

      • Chemistry

      • Biology

      • Medical Technology

      • Other fields of study may be appropriate

EARN GRADUATE CREDITS!

MCCC has an articulation agreement with Drexel University College of Medicine.

Participants who successfully complete the Certificate in Clinical Development

and Regulatory Affairs earn nine (9) graduate credits when they

apply and gain acceptance to Drexel University’s Master Degree in Clinical Research Organization and Management.

For more information regarding the Certificate of Clinical Development and Regulatory Affairs, please e-mail us.

 

Required Courses

      • Foundations of Clinical Development: Prerequisite for all other courses.

      • Regulations and Compliance

Elective Courses (Choose one)

      • Fundamentals of Clinical Research Monitoring and Study Coordination

      • Clinical Data Management

      • Clinical Quality Assurance

 

Foundations of Clinical Development

Required course.

Foundations of Clinical Development introduces students to the process of bringing a new pharmaceutical or medical device to market. Principles of good clinical practices and the elements of informed consent as well as regulations and compliance will be discussed. Upon completion of this course, participants will be able to describe the stages of development for biologics, medical devices and pharmaceuticals as well as the roles and responsibilities of sponsors, investigators, and clinical research professionals. Textbooks required and available in the college bookstore. Students must obtain the textbook prior to the start of class.

3.6 CEU. Cost: $1,003 (tuition $853, administrative fee $150)

NCPHA-CS001-01

February 6 - 25 

9 sessions / Mondays, Wednesdays & Saturdays* / 6-9pm*

*Saturday classes (February 11, 18 and 25) meet 9am-4pm. One hour is provided for lunch;

please bring lunch as the cafeteria is closed on Saturdays.

Instructor: Walid Abdelwahed

Regulatory Affairs Regulations and Compliance

Prerequisite: Foundations of Clinical Development

Students must have access to a computer, Microsoft Office compatible software, a web browser (either Mozilla Firefox or Google Chrome) and reliable access to the Internet.

Regulatory Affairs: Regulations and Compliance introduces students to the impact of regulation on clinical development of new biologics, pharmaceuticals and vaccines. Upon completion of this course, participants will be able to describe the differences between an Investigational New Drug Application (IND), a Biologic License Application (BLA), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), and a Pre Market Application (PMA).  Students will also gain an understanding of FDA and ICH guidelines and regulations as well as the FDA Bioresearch Monitoring program.

3.6 CEU Cost: $1048 (tuition $853; administrative fee $150; student fee $45)

NCPHA-CS008-01 

March 4 - April 1 

Instructor: Michael Falkow

 

Clinical Quality Assurance

Prerequisite: Foundations of Clinical Development

This course is designed to provide participants with a thorough understanding of current Good Clinical Practices (GCPs) and Clinical Quality Assurance (CQA) requirements in detecting study misconduct and fraud in global clinical trials. Additionally, participants will learn how to develop an audit plan and conduct site and vendor audits. Included in the course work will be the development of Corrective and Preventative Action Plans. Materials provided.

3.6 CEU. Cost: $1,003 (tuition $969; administrative fee $19, materials fee $15)

NCPHA-CS006-01

March 7 - 13  

12 sessions / Tuesdays & Thursdays / 6-9pm

Instructor: Renee Blanco-Fisher  

Fundamentals of Clinical Research Monitoring and Study Coordination

Prerequisite: Foundations of Clinical Development

Students must have access to a computer, Microsoft Office compatible software, a web browser (either Mozilla Firefox or Google Chrome) and reliable access to the Internet.

The Clinical Coordination and Monitoring course was developed to educate Clinical Research Associates (CRAs) and Clinical Research Coordinators (CRCs) as well as members of the clinical research project team who interact with them. In this course, students are introduced to clinical trial activities as they directly relate to the CRA and CRC job functions while becoming educated in the various facets of clinical trial monitoring including the CRA/CRC roles and responsibilities, general study design, investigative site selection/feasibility, regulatory document collection, types of monitoring visits, privacy, risk management and fraud in clinical research today. The importance of pre-study, initiation, interim monitoring and close-out visits, including a review of the FDA Guidance on Risk-Based Monitoring, will also be discussed.

3.6 CEU. Cost: $1,048 (tuition $853; administrative fee $150, student fee $45)

NCPHA-CS005-01

April 8 - May 6 

Online Orientation and 36 hours of online instruction

Instructor: Jill Johnston

 

Clinical Data Management

Prerequisite: Foundations of Clinical Development

Clinical Data Management provides participants with a general overview of the steps involved in managing clinical data in global clinical trials. Traditional aspects of clinical data management will be discussed including the role of the clinical data manager in the development of a clinical trial protocol, the design and completion of case report forms, and the design of the clinical database. In addition, the course will cover methods of data collection and data entry, data validation, data query and resolution, the use of current industry standards in clinical data management, the use of quality control procedures, and interaction with both clinical research and bio statistics personnel.

3.6 CEU. Cost $1,003 (tuition $853, administrative fee $150)

NCPHA-CS002-01

April 20 - May 11  

7 sessions / Tuesdays & Thursdays** /   6 - 9pm

2 sessions / Saturdays,April 22 and 29 / 9am-4pm (includes one hour lunch break)

1 session / Saturday, May 6 / 9am-12noon

Instructor: Denise Tsilionis

 


CONTACT US:

Registration Desk: 609-570-3311

Register online here.

Questions: E-mail us

 

REFUND POLICY: 
10 or more days before the beginning of a class: 100% refund

Less than 10 days before class start date: no refund

Credit card payments will be refunded to the credit card; cash and check payments will be refunded via a check from MCCC.



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