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CLINICAL DEVELOPMENT AND REGULATORY AFFAIRS


CLINICAL DEVELOPMENT

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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 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 (Online)
Elective Courses (Choose one)
  • Fundamentals of Clinical Research Monitoring and Study Coordination
  • Clinical Data Management
  • Clinical Quality Assurance

FALL 2020

Foundations of Clinical Development  (REMOTE)

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.

 

NCPHA-CS001-01 / 3.6 CEU / cost: $1,100 

Dates  Sep 14 – Oct 3                 Time   6:00-9:00pm (M, W); 9:00am-4:00pm (SA) w/ 1 hour lunch

Sessions     9        Instructor     Michael Falkow

Day    M, W, SA      NOTES SA classes: Sep 19,26; Oct 3 

 


Regulatory Affairs: Regulations and Compliance (Online)

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.

 

NCPHA-CS008-01 / 3.6 CEU / cost: $1,100 

Dates  Oct 2- Nov 12                  Time   Online

Sessions     Online            Instructor     Michael Falkow

Day    Online           NOTES        

 


Fundamentals of Clinical Research Monitoring and Study Coordination (Online)

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.  

 

NCPHA-CS005-01 / 3.6 CEU / cost: $1,100

Dates  Sep 17 – Nov 5                           Time Online

Sessions     10       Instructor     Jill Johnston

Day    Online                     NOTES        

 


Clinical Quality Assurance  (Remote)

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. 

 

NCPHA-CS006-01 / 3.6 CEU / cost: $1,100

Dates  Oct 20 – Dec 1                 Time 6:00-9:00pm

Sessions     12      Instructor     Michael Falkow

Day    TU, TH                    NOTES Nov 26      

 


Clinical Data Management   (Remote)

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.

NCPHA-CS002-01 / 3.6 CEU / cost: $1,100

Dates  Nov 11-Dec 21   Time M, W 6:00-9:00pm

Sessions  12  Instructor  Vedrana  Susulic

Day M, W  NOTES  

 


 

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