Alfred Hunt
Hunt Pharma Solutions
Referent:innen
Dr Daniel Müller
GMP Inspector
Jonathan Riley
Takeda UK
Dr Torsten Schmidt-Bader
moveproTEC Compliance & Innovation Advisory
Zielgruppe
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.
Zielsetzung
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.
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.
Programm
The EU GDP Guidelines
- 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.
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
Weitere Informationen
Venue
Radisson Blu Scandinavia Hotel
Amager Boulevard 70
Radisson Blu Scandinavia Hotel
Amager Boulevard 70
2300 Copenhagen S
Denmark
+45 (0)33 96 50 00
+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.
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.
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.
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.
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 official conference language will be English.
Contacts
Questions regarding content:
Dr Markus Funk, +49 (0)6221 84 44 40, funk@concept-heidelberg.de
Questions regarding organisation:
Ms Nicole Bach, +49 (0)6221 84 44 22, nicole.bach@concept-heidelberg.de
Datum & Uhrzeiten
Wed., 06 May 2026, 09.00 - 18.00 h
Thu., 07 May 2026, 08.30 - 15.30 h
Thu., 07 May 2026, 08.30 - 15.30 h
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
| GDP Association Member Discount*: | € 1890,- |
| QP Member Discount*: | € 1890,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified GDP Compliance Manager"
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E-Mail: info@concept-heidelberg.de
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