October 15 - 18, 2019 | Sheraton Boston, MA

RAFIK BISHARA, Ph.D.

Technical Advisor & Former Director QKMITS Eli Lilly & Company

Dr. Bishara has become one of the most respected figures in the pharmaceutical supply chain distribution sector, following a distinguished 35 year career with Eli Lilly & Co. as Director, Quality Knowledge Management and Technical Support. 

During his tenure at Eli Lilly and Company, Dr. Bishara was responsible for Quality Knowledge Management, Global Compendial Affairs, Stability and Distribution Excellence, Global Product Protection, Special Security Substances and Controlled Substances Administration. 

Dr. Bishara has worked consistently towards harmonization of many global regulations and guidelines for the handling, storage and transportation of pharmaceutical and biotech products. He has chaired and presented at industry leading conferences

Dr. Bishara has authored numerous articles, and technically advised several organizations on Good Cold Chain and   Temperature – Controlled Management. His current focus include Supply Chain Integrity and Security.


Site Tour, Workshops, Master Class Day and Icebreaker Welcome Drinks: Wednesday, October 16, 2019

Wednesday, October 16th, 2019

3:00 PM Looking Beyond the Cold Chain: Preparing your Supply for Increased Vigilance of CRT Products

With regulators across the globe becoming increasingly interested in how organizations are controlling the variables when distributing CRT/Ambient products, companies must re-assess their processes to ensure compliance. Even if total temperature monitoring is not required by regulators, it is crucial to show that you have strong processes in place to stay off their radar. Regulators want to see that you have your documentation in order for these products and have a full understanding of your transport process.

From this workshop you will walk away with insight on how to:
  • Calculate accurate temperature profiles for ambient products and properly analyze data collected
  • Understand the environment where your products will be traveling and how to best control the elements
  • Define your routes through qualification & validation of shipping lanes and profiling using historical data
  • Pinpoint the packaging required to seamlessly ship ambient products globally and where a more custom design is needed
  • Discuss the global GDP landscape for CRT products and where your products get flagged more often

Main Conference Day One: Thursday, October 17, 2019

Thursday, October 17th, 2019

1:00 PM 2. Good Distribution Practices (GDP) - Risk Assessment

+ The development of shippers - Qualifications
+  Shipping lane qualification – Hot and cold profiles, carrier, temperature monitoring, etc.

Check out the incredible speaker line-up to see who will be joining RAFIK.

Download The Latest Agenda