Clinical Supplies: The Basics and Beyond

Join us for an exciting three-day course which will focus on the fundamentals and select advanced topics of the clinical supplies process.

The course covers both US and EU perspectives.

Our goal is to have each person return to their organization with the skills and enthusiasm to be a more confident and productive team member.

YOU WILL LEARN HOW TO LABEL AND PACKAGE BLINDED CLINICAL SUPPLIES DURING OUR HANDS-ON WORKSHOP.

The management of clinical trial materials is a complex, specialized skillset. Our instructors have extensive experience managing large, international trials. Our clinical supplies training focuses on best practices for clinical supplies from both GCP and GMP perspectives, and covers both US and EU expectations,  and will help your team remain current with the latest industry and regulatory trends.

INSTRUCTORS

Greg Kushla, Executive Director of Jeiven Pharmaceutical Consulting, Inc. 

Greg brings more than 20 years of research and Clinical Supplies experience to the course. Prior to joining JPC, Greg was Sr. Director, Clinical Supply Operations for Daiichi Sankyo. He has held pharmaceutical R&D management positions at Abbott Laboratories (formerly Knoll Pharmaceutical) and Parke-Davis. Greg brings his strong knowledge of Clinical Supplies, GMPs, and FDA regulations to our clients through his consulting, training and auditing. Greg received his degrees from Rutgers University.

Steve Jacobs, President of Global BioPharm Solutions, LLC

Steve is the President of Global BioPharm Solutions, a company that does training, consulting, and executive coaching for the Pharma and Biotech industry. Prior to this, he was President of Bilcare Clinical Packaging and Research in Phoenixville, PA. He has also held key clinical supplies leadership and management positions at J&J, McNeil and Otsuka America Pharmaceuticals. Steve is also the Chairman of the Board for the Global Clinical Supplies Group.

Refund/Cancellation Policy

We understand that sometimes due to unforeseen circumstances people are unable to attend a course they have registered for. Please click here to see our course refund page and to see our policies regarding course cancellation.

Register Today

For registration or any questions please contact us at (908) 233-4508

Clinical Supplies: The Basics & Beyond Topics

  • Introduction to Clinical Supplies and cGMPs

  • Phases of New Drug Development and the Drug Approval Process

  • Clinical Supplies Life Cycle

  • Quality Assurance and Change Control

  • Good Documentation Practices and Production Records

  • Developing, Writing, and Controlling SOPs

  • Blinding and Randomization Concepts

  • Clinical Protocol Interpretation

  • Packaging and Labeling Clinical Trial Material

  • Patient and Site Compliant Packaging and Labeling

  • Stability and How it Generates Expiry/Retest Dating

  • Material Control and Warehousing

  • Shipping and Distribution – including Good Distribution Practices

  • Returned Drug Accountability

  • QP Responsibilities Including Certifications and Declarations

  • Clinical Trial Directive

  • ½ day Packaging and Labeling Workshop

THIS COURSE CAN BE CUSTOMIZED AND OFFERED ON-SITE AT YOUR COMPANY. CONTACT US FOR MORE INFORMATION.

Register Today

For registration or any questions please contact us at (908) 233-4508