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Clinical Devlopment

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:

  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, 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

Sep 17

Oct 6

9

M, W

Sa

6:00-9:00pm

9:00am-4:00pm

Michael Falkow

Sat classes: Sep 22, 29, Oct 6 (1hr lunch)


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

Oct 2

Nov 3

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

Nov 1

Dec 13

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

No class Nov 22


Fundamentals of Clincal 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.


3.6 CEU

Cost: $1,100

NCPHA-CS005-01

Dates Sessions Day Time Instructor

Sep 11

Nov 17

online     David Pfenning

Introduction to Pharmacovigilance

Please note: this is a standalone course and is  not part of the certificate.

Introduction to Pharmacovigilance will provide a basic foundation in the key components of premarketing, clinical, and postmarketing pharmaceutical safety surveillance. The course will cover the fundamental aspects of the conduct and context of Pharmacovigilance with emphasis on understanding of its concepts and will address common themes underlying effective Pharmacovigilance processes. Basic global regulatory compliance in safety surveillance and therapeutic risk management will be presented.
This course is designed for those who want to learn about safety surveillance, therapeutic risk management, and benefit-risk evaluation of therapeutics, including drugs, biologics, devices, and vaccines. Content includes various basic aspects of therapeutic safety issues during the clinical development of drugs, biologics, devices and vaccines, and monitoring and surveillance to assess post-marketing adverse effects of therapeutics.


Individuals working in the field of Clinical R&D, Safety or Therapeutic Risk management for drugs, biologics, devices, or vaccines, Regulatory Affairs/ Labelling, Health Care professionals in clinical trials or clinical care settings dealing with therapeutic safety issues, Public Health professionals, Journalists in the health care sector or other relevant fields may find this course useful.


3.6 CEU

Cost: $1,100

NCPHA-CS009-01

Dates Sessions Day Time Instructor

Sep 6

Oct 20

10

Th

Sa

6:00-9:00pm

9:00am-3:00pm

Lourdes Frau

Th classes: Sep 6,13, 20, 27, Oct 4,11,18

Sat classes: Sep 22, Oct 6, Oct 20

1hr lunch


 

 

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