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Moving You Forward

Clinical Devlopment


 

Join us for a

FREE INFORMATION SESSION

Learn about the course details
Gain an understanding of the application process
Meet our program staff
Ask questions about the program, enrollment requirements, and more!
Tuesday, December 11 | 6:00-7:00pm
The Conference Center at MCCC
1200 Old Trenton Road, West Windsor, NJ 08550
To reserve your seat at the FREE information session, call 609-570-3111 today!

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 highly experienced instructors, and welcomed guest speakers who bring added expertise to the program.



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

  1. Define the roles and responsibilities of Sponsor, Monitor, and Investigator as they relate to the conduct of global clinical trials.
  2. Recognize clinical trial documentation differences for biologics, medical devices, and pharmaceuticals.
  3. Describe differences between regulatory submission requirements of new biologics, medical devices, pharmaceuticals, and vaccines.
  4. Discuss the impact of FDA regulations and guidance documents, EU directives, EMEA regulations and ICH GCP on clinical development.
  5. 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 of 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 may earn up to 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 email ComEd@mccc.edu.

Required Courses
  1. Foundations of Clinical Development: Prerequisite for all other courses.
  2. Regulatory Affairs Regulations and Compliance (Online)
Elective Courses (Choose one)
  1. Fundamentals of Clinical Research Monitoring and Study Coordination
  2. Clinical Data Management
  3. Clinical Quality Assurance

Foundations of Clinical Development

Required course


Foundations of Clinical Development introduce 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.

Textbook required and is available in the college bookstore. Students must obtain the textbook prior to the start of class.


3.6 CEU

Cost: $1,100

NCPHA-CS001-01

Dates Sessions Day Time Instructor

Feb 4

Feb 23

9

M, W

Sa

6:00-9:00pm

9:00am-4:00pm

Michael Falkow

Saturday classes: Feb 9, 16, 23 (1 hour lunch)


Fundamentals of Clinical Research Monitoring and Study Coordination (Online)

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. Online Orientation and 36 hours of online instruction  

3.6 CEU

Cost: $1,100

NCPHA-CS005-01

Dates Sessions Day Time Instructor

Feb 11

Apr 19

online Robert Centofanti

 


Regulatory Affairs: Regulations and Compliance (Online)

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 (INDA), a Biologic License Application (BLA), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), and a PreMarket 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: $1,100

NCPHA-CS008-01

Dates Sessions Day Time Instructor

Mar 1

Apr 2

online Michael Falkow

Clincal 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: $1,100

NCPHA-CS006-01

Dates Sessions Day Time Instructor

Apr 9

May 16

12 Tu, Th 6:00-9:00pm Michael Falkow

 

 

 

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