From innovative oncology therapeutics, to COVID vaccine development, Good Clinical Practice (GCP) has become the unifying standard for the design, management, documentation and reporting of clinical trials. This comprehensive document has established instructional guidelines that provide life science companies with an in-depth understanding of what is expected from a new drug or treatment. PharmAllies looks forward to providing you with a deeper look into these regulatory guidelines framed by transparency and the desire to establish safe and effective treatments for every patient in need.

Learning Objectives

• When were Good Clinical Practice guidelines first put in place?
• What are the goals of the GCP guidelines?
• How has GCP played a role in the research and development of a COVID-19 vaccine?
• What are the main roles of a PM in clinical trials, and how much do you need to know?
  

 

Peniel Ortega is the Managing Director for PharmAllies, a life science consulting firm based out of NJ. He is responsible for defining and implementing strategic and tactical plans, ensuring the successful operation of the firm. His guidance has set in place future strategy designed for positioning PharmAllies as the #1 life science consulting firm in the region.
Peniel is a Certified Six Sigma Black Belt with proven success in delivering improved performance through critical path thinking, team-building, and problem-solving. He is a Certified Project Manager Professional (PMP) with expertise in the pharmaceutical, medical device, and biotech industries. He is also a subject matter expert (SME) in risk-based qualification, computer system validation (CSV), decommissioning, and data integrity programs.

In addition to his boots on the ground expertise, he has also taught graduate-level project management courses for Stevens Institute of Technology in Hoboken, NJ. He has an MS in Engineering Management and a BS in Chemical Engineering from NJIT.
 

Normal registration: Thru 10 Dec

• $0.00 - PMINJ Chapter members (fee waived for this meeting)
• The link to the virtual meeting will be included in the Registration Receipt
• Download the Zoom app at: https://zoom.us/download