BSMA Webinar Registration

The Supply Chain Implication of EU Regulatory Annex 16

July 11, 2017: 10-11AM PDT, 12-1PM CDT, 1-2PM EDT 

Synopsis:

In April 2016 the European Commission’s Annex 16: Certification by a Qualified Person and Batch Release came into effect. This revision increased the requirements for both medicinal products for human use with a marketing authorization (MA) and to Investigational Medicinal Products imported into the EU/EEA. A new requirement – Section 1.7.2. – calls for end-to-end visibility of the supply chain in the form of a Supply Chain Diagram.

Attend this Webinar to learn more about the scope of the Supply Chain Diagram and how to adapt your processes in order to provide this information to a Qualified/Responsible Person  

After registering, you will receive a confirmation email containing information about joining the webinar.

There will be time for Q&A.

So what are you waiting for? Register today to learn how to get DSCSA compliant before the deadline! You’ll be on your way to making it your goal!

Produced by: 


Who’s Presenting?

 

Host Ryan Mills is an Associate Director, Operations at Enterey Life Sciences Consulting. His background consists of 10+ years of Supply Chain and Project Management experience across biotechnology, pharmaceutical and hi-tech industries.   His current projects focus on the intersection between Quality, Regulatory, and Supply Chain to ensure compliance and improve efficiency.

Ryan’s other professional experiences include multiple functional areas: Supply Chain planning, Business Process Manage ment, and Finance.

Ryan holds an MBA from North Carolina State University with an emphasis in Supply Chain Management and Finance as well as a BA, Psychology from the University of California, Berkeley.

Co-Host Jennifer S. Silverstein is a Senior Consultant at Enterey Life Sciences Consulting.   Over her 10+ years within the industry, she has worked primarily with process development, regulatory and quality functions to implement solutions that reinforce a client’s strategic vision, objectives, and target growth. ​ ​
Within the past few years her projects have consisted of coordinating the global harmonization and implementation of a comprehensive Quality Risk Management (QRM)​ program for ​clinical development in compliance with Q9 and Q10, managing the creation of an Investigational Medicinal Product (IMP) Supply Chain Diagram through reformation of the client’s existing internal tools and business processes, and supporting a client’s adoption of Lean Production Systems (LPS) by conducting gap analyzes or launching new communication tools focused​ on the LPS Elements Continuous Improvement and People and Organization respectively.​

Jennifer received her B.S. in Chemical Engineering and Economics from Rensselaer Polytechnic Institute and her M.S. in Biotechnology from Johns Hopkins University.

Daniel Lau is currently the Associate Director of Quality at Gilead responsible for the quality oversight of Gilead clinical programs.  He has been a quality professional for over 27 years in the pharmaceutical industry.  His current 17-year tenure with Gilead has led him to play significant roles in the clinical development of Gilead HIV and HCV franchises including the commercialization of a number of best in class therapies including Truvada®, Atripla®, Stribild®, Sovaldi®, and Harvoni®. 

He is a graduate of University of California at Berkeley in Biological Sciences.

Dr. Ulrich  Huth, the Qualified Person, Head of IMP Quality Grenzach at Roche Pharma AG, is responsible for the final release /certification of all Roche clinical trial material within the European Union.  He has over 17 years’ experience as a quality professional within research & development and in the pharmaceutical industry.  Over the past 2 years Ulrich was heavily involved in the implementation of the latest Annex 16 revision within his area of responsibility.  He is pharmacist by education and received his PhD in Pharmaceutical Technology from University of Freiburg in Germany.

 

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