Drug Supply Chain: Assessing the New EU Falsified Medicines Directive Issued & FDA’s Drug Supply Chain Security Act Implementation Guidance

Live, Interactive Training Webinar

Date: Available Live On-Demand
Instructor: Peter Calcott Ph.D. Biography>>>

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Your products are your life blood but are they secure? How can you be sure that they are not at risk or compromised in the market place? This is something that people only think about after something bad happens. Both the Europeans and US regulatory bodies are taking a stand with the issuance of the Falsified Medicines Directive issued in 2011 and the Guidance to Industry: Drug Supply Chain Security Act Implementation in 2014. As of August 2013, the European directive must be implemented in the EU for products sold there in a staged fashion. Both regulatory approaches have some of the same features, but the European one goes much further. If you are selling drugs in the EU, you may have implemented all the requirements – but maybe not. If you are a US or Canadian manufacturer, this is something that may be on your radar. While the Directive is not required outside the EU, we can learn a lot from the way the Europeans think. It will spur you to examine your own supply chain to build assurances in before disaster strikes. This will put you ahead of the curve building a stronger, more robust supply chain before the US and Canada catches up.

In this live training webinar we will examine the supply chain and its risks in the context of the new EU Directive and the US guidance. We will examine how to use modern Quality Risk Management to identify, analyze, prioritize risk and develop remediation to address the risk to the supply chain. We will examine the elements including assuring Active Pharmaceutical Ingredients and Excipients security and quality, the effect of the distribution chain on the finished drug product and measures to assure security in the supply chain. We will examine some of the recommendations for assuring authenticity of drugs in the market place including identifiers on packs, in on-line commerce and the increased oversight of drug brokers and repackagers called for. We will see how much further the EU is ahead of the US in the process.

Learning Benefits:
-How to examine your supply chain and with the use of Quality Risk Management identify where risk is present at unacceptable levels.
-How to develop a remediation plan to decrease risk to an acceptable level in your supply chain.
-The driving forces (the where and why) behind the European desire for supply chain security with the Falsified Medicines Directive and the US guidance for identification of counterfeit products.
-How to work with your suppliers of API and Excipients to strengthen the security of the supply chain at the front end.br> -How to develop a stronger relationship with your distributors and drug brokers to increase security at the back end.br> -How to interpret the regulations which were designed for commercial operations in a clinical world.
-How to be proactive in areas the FDA is silent by learning from the Europeans and being ahead of the game.

Regulations that will be Covered:
Each country has its own specific sets of regulations. Below are citations from ICH and examples of regulations that are applicable to the inspection and response processes and philosophy:

Code of Federal Regulations 21 sections 210, 211 for Biological products and Drugs and 600 series for Biologicals in addition for USACode of Federal Regulations 21 sections 210, 211 for Biological products and Drugs and 600 series for Biologicals in addition for USA.
Health Canada regulations for pharmaceutical and biotechnology products including appropriate annexes such as 1, 2, 3, 18.
EMEA Eudralex Volumes 1, 2, 3, 4, 9 for Drugs and Biologics in EU.
EU Guidance on Good Distribution Practices
EU Falsified Medicines Directive – May 2011
US Guidance to Industry: Drug Supply Chain Security Act Implementation – Issued in June 2014
International Conference on Harmonization Quality Series Q1 through Q11 for USA, EU, Japan and other countries with an emphasis on ICH Q9.
International Conference on Harmonisation Quality Series Q1 through Q11 for USA, EU, Japan and other countries with an emphasis on ICH.

Webinar outline and time breakdown:

12:45 PM Log In Period
1:00 PM Introduction
1:10 PM Recognizing the driving force in Europe for change,
What does the EU Falsified Medicines Directive say?,
What it means for the EU market and how it affects other markets,
Mapping your supply chain,
Determining risk in the supply chain using ICH Q9,
2:00 PM Break
2:10 PM Active pharmaceutical ingredient assurances,
Strengthening the Excipient supply,
Distribution chain weaknesses,
Building safeguards in the product for rapid identification and assurance,
How it applies in the US and Canada,
3:00 PM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

  • A copy of the presentation slides
  • A certificate of participation for attendee training records

Who should attend:

The following individuals or disciplines will benefit from attending this Webinar:

  • Quality Assurance Personnel
  • Quality Control Personnel
  • Supply Chain and Logistics Managers
  • Regulatory Affairs Professionals
  • Process Development Scientists and Management
  • Manufacturing Management and Scientists
  • Project Managers working in the CMC arena
Schedule & Deliver this Live Training Webinar Privately to Your Group

Instructor: Peter Calcott Ph.D.

Peter H. Calcott, Ph.D. is President, Calcott Consulting which is focused on delivering solutions to pharmaceutical and biotechnology companies in the areas of corporate strategy, supply chain, quality, clinical development, regulatory affairs, corporate compliance and enterprise e-solutions. He is also an Academic Program Developer for the University of California, Berkeley’s Biotechnology and Pharmaceutics Postgraduate Programs. Prior to this he was VP at the executive team level at PDL BioPharma where he was responsible for development and implementation of Quality & Compliance strategy across the corporation… Full Bio>>>


Course Number: 312

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