The Responsible Person for Good Distribution Practice (GDP)
6/7 May 2026, Copenhagen, Denmark
Course No. 22241
Speakers
Dr Daniel Müller
GMP Inspector
Jonathan Riley
Takeda UK
Dr Torsten Schmidt-Bader
moveproTEC Compliance & Innovation Advisory
Alfred Hunt
Hunt Pharma Solutions
Objectives
The EU-GDP Guidelines require that wholesale distributors have to appoint a Responsible Person (RP) for GDP. There has been a lot of discussion about the duties of the RP. Therefore, the ECA Foundation’s GDP Working Group has developed this training course. In this course, the role and responsibilities of the Responsible Person for GDP will be highlighted and discussed.
Background
In 2013 the “Guidelines on Good Distribution Practice of Medicinal Products for Human Use” were published. The Guidelines were revised to take into account advancements of practices for an appropriate storage and distribution of medicinal products in the European Union.
In Chapter 2 “Personnel”, tasks and responsibilities of the RP are defined. RPs should fulfil their responsibilities personally and should be continuously contactable. The RP should have appropriate competence and experience as well as knowledge of and training in GDP. He or she may delegate duties but not responsibilities. The RP should carry out their duties in such a way as to ensure that the wholesale distributor can demonstrate GDP compliance and that public service obligations are met.
Background
Wed., 06 May 2026, 09.00 - 18.00 h Thu., 07 May 2026, 08.30 - 15.30 h
Target Group
The Training Course is of particular interest to Responsible Persons but also management and quality personnel from pharmaceutical companies, wholesalers, distributors and service providers involved in distribution of medicinal products.
Venue Radisson Blu Scandinavia Hotel Amager Boulevard 70
2300 Copenhagen S
Denmark +45 (0)33 96 50 00
Accommodation CONCEPT HEIDELBERG has reserved a limited number of rooms. You will receive a room reservation form/POG when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
Fees (per delegate, plus VAT) European GDP Association Members € 1,890.- ECA and European QP Association Members € 1,890.- APIC Members € 1,990.- Non- Members € 2,090.- EU GMP Inspectorates € 1,045.- The conference fee is payable in advance after receipt of invoice and includes dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable.
Social Event On the evening of the first course day, you are cordially invited to a social event. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Presentations/Certificate The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
The counterfeit directive and the introduction of the EU GDP Guidelines
GDP requirements for the pharmaceutical supply Chain
Regulatory expectations for implementation
What is the RP and Wholesaling
Qualification and experience requirements for RP
The Role of RP in management of export & Import
Annex 21: Importation of medicinal products
Export & import to and from EU
Experiences from GMDP Inspections
Inspections of the competent authorities
Typical GDP inspection findings
Controlled Temperature Distribution
How to manage cold chain products
How to manage 15 - 25 °C requirements
Air freight, sea freight, road transport and the last mile
GDP Audits and Self-Inspections
How to plan audits and self-inspections
Supplier / vendor audit and self inspection approaches
Reporting deficiencies
Examples of recent findings
Roles and Responsibilities of the RP
Qualifications requirements for RPs
Responsible Person vs. Qualified Person
GDP vs. GMP
Duties and Delegation
How to discharge your duties
Handling of returned and damaged goods
Complaint Handling
Validation of Computerized Systems under GDP Regulation
Validation requirements – regulatory overview
GAMP oriented validation approach of GDP critical systems
Case Study: Validation of a new Warehouse and Material Management System
Wholesaler in Germany
Workshop: Deviation Management During this workshop participants will learn and discuss how to ensure that the deviation system is being correctly used and implemented.
Security in the Supply Chain
Counterfeit / falsified pharmaceuticals – a real threat!
What is pharma industry doing about it?
Recent developments
How can track & trace support anti-counterfeiting requirements
This course is part of the GMP Certification Programme "ECA Certified GDP Compliance Manager" Learn more
Testimonials
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