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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
  1. Nursing
  2. Pharmacy
  3. Chemistry
  4. Biology
  5. Medical Technology
  6. 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
  4. Introduction to Pharmacovigilance

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
Jun 4
Jun 23
9 M,W,Sa 6:00-9:00pm Michael Falkow

 

Saturday classes on Jun 9, 16, 23
No class May 28, Jul 2, Jul 4


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
Jun 1
Aug 6
online Michael Falkow

 


Introduction to Pharmacovigilance

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
May 9
Jun 16
9 W, Sa 6-9pm Lourdes Frau

 

Sat classes: May 19, Jun 2, 16 (9am-3:30pm)
½ hr lunch
Final exam: either 6/13 or 6/16 , depending on class size
Final project : 6/16

 

 

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