CLINICAL DEVELOPMENT AND REGULATORY AFFAIRS
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:
- 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, and 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 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
- Foundations of Clinical Development (Prerequisite for all other courses)
- Regulatory Affairs Regulations and Compliance
Elective Courses (Choose one)
- Fundamentals of Clinical Research Monitoring and Study Coordination
- Clinical Data Management
- Clinical Quality Assurance
Attention: Registration for classes may close seven (7) days prior to the start date depending on enrollment numbers. If you cannot find a class you are looking for, please reach out to the Non-Credit Registration Desk at (609)570-3311 or email ComEd@mccc.edu for further information. The Center for Continuing Studies also suggests not purchasing textbooks until seven (7) days prior to the start date of a class to ensure the class is running.
Foundations of Clinical Development
Required course
Introduces you 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, you 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
Offered Spring and Fall
Cost: $1,200
Regulatory Affairs: Regulations and Compliance
Prerequisite: Foundations of Clinical Development
Required: Access to a computer, Microsoft Office compatible software, a web browser (either Mozilla Firefox or Google Chrome) and reliable access to the Internet.
Introduces you to the impact of regulation on clinical development of new biologics, pharmaceuticals, and vaccines. Upon completion of this course, you 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). You will also gain an understanding of FDA and ICH guidelines and regulations as well as the FDA Bioresearch Monitoring program.
3.6 CEU
Offered Spring and Fall
Cost: $1,200
Fundamentals of Clinical Research Monitoring and Study Coordination
Prerequisite: Foundations of Clinical Development
Required: 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
Offered Spring and Fall
Cost: $1,200
Clinical Quality Assurance
Prerequisite: Foundations of Clinical Development
This course is designed to provide you 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, you 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
Offered Spring and Fall
Cost: $1,200
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 biostatistics personnel.
Offered Spring and Fall
Cost: $1,200