Jersey City, NJ (New York City Metro Area), USA
Kurs Nr. 9170
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Dr Susanne Ding
Boehringer Ingelheim, Germany
Medical Products Agency, Sweden
Medicines & Healthcare Products Regulatory Agency (MHRA), U.K.
Afshin Hosseiny, Ph.D.
Tabriz Consulting Ltd., U.K.
Form. Irish Medicines Board, Ireland
The aim of this conference is to inform about the latest requirements when it comes to distribution of medicinal products to and within the European Union (EU). Challenges and possible solutions will be discussed and examples will demonstrate how the new European requirements can be put into practice.
The globalisation of the pharmaceutical supply chain has created new challenges for manufacture and supply of medicinal products in various markets, resulting in reduced control and increased security risk to the products.
The EU Directives and GDP Guidelines have been extensively revised to take into account the changing nature of the globalised supply chain.
The new EU GDP Guidelines are effective since 2013 (2013/C343/01). . These requirements highlight the need for an effective quality management system supported by risk assessment and appropriate controls in the distribution chain. Do you think you are compliant with the new requirements?
In 2014, PIC/S published their Guide to Good Distribution Practice for Medicinal Products (PE 011-1), adapting the EU GDP Guidelines for PIC/S purposes.
Already in 2011, the European Commission published Directive 2011/62/EC, the so called Falsified Medicines Directive (or FMD).The main goal is the fight against counterfeit medicines. In 2014 the technical characteristics of one key requirement were defined, the unique identifier delivering the possibility of verification of the authenticity of single folding boxes. This will be a 2D barcode (data matrix). As this new requirement will become active in 2018, it is time to start defining strategies for both technical implementation and change control strategy.
Managers and Executives from companies involved in the distribution and supply of pharmaceutical products to the European Union.
Introduction: The Distribution Chain to the EU and within the EU
How distribution is changing: challenges and things to consider
The Need for a GDP Working Group
ECA’s GDP Working Group
The Authority’s Point of View
Who is responsible for maintaining product quality in the Supply Chain
The existing international agreements and organisations linked to EU (MRAs, PIC/S, ICH, etc.)
Marketing Authorisation Procedures
What are Manufacturing Licence, GMP and GDP Certificate, Import Licence, CEP (what is what, how to get it)
The GMP and GDP Inspection process (in and outside the EU)
The PIC/S adaption of the EU GDP Guidelines
The new Directive on Falsified Medicines (2001/83/EC)
The need to strengthen control and supervision
What goes along with the Directive: Guidelines and Delegated Acts
The delegated Act: Identification with the 2d matrix Code
GMP compliance of the manufacturer
The written confirmation
Technical and regulatory Aspects for changing the Secondary Packaging (Barcode, Safety Features)
Part 1: Artwork, packaging and quality control: what needs to be considered
Part 2: Applicable EU Change Control requirements
Track & Trace
The European Stakeholder Model (ESM) and the European Medicines Verification System (EMVS),
Experiences made with the pilot programme in Sweden
Anti-Counterfeiting provisions from company to patient and Identification with the 2d matrix Code – what the future will bring
Other systems: EDQM Anti-counterfeiting Traceability Service for Medicines (eTACT), Aegate
Some Practical Concerns from the EU Inspectorates
The EU inspection process
Links and communications between US and EU partners
Security in the supply-chain (examples of crime, tampering etc.) and ways to reduce risks
What does an EU regulator/ inspector expect from both, the US based company and the EU branch when it comes to GDP and Track&Trace
What could be an adequate Change Control Strategy?
The new EU Guidelines on GDP an their Impact for the global Pharmaceutical Industry
Background to development and revision of the new EU GDP Guidelines
Well-known or new: a summary of the most important changes
What is the impact on industry and other stakeholders?
The new EU Guidelines on GDP in Practice
How to plan and implement a programme to meet compliance with the current requirements (from gap analysis to implementation)
How to develop and implement a GDP-compliant and cost effective transportation network
Qualification of suppliers and customers
How to develop and manage contracts and agreements
Training of personnel involved in the supply chain
Qualified Person vs. Responsible Person
Who needs a Responsible Person (RP)?
Who needs a Qualified Person (QP)?
The Qualified Person: why to certify the batch again?
The new role of the Responsible Person
QP and RP: where does the responsibility start, where does it end?
Case Study: IMP distribution
How the new regulations impact IMP distribution
IMP shipments into the EU from other countries
Global comparator sourcing
Control of distribution centres