Dr Susanne Ding
Boehringer Ingelheim Pharma
Referent:innen
Patryk Jegorow
Takeda
Dr Sue Mann
Sue Mann Consultancy
Zielgruppe
New colleagues becoming IMP QPs, QPs looking for continuous training and personnel of CROs and “non-commercial” IMP organisations.
Zielsetzung
This pre-course session provides a detailed overview of the specific characteristics in IMP manufacturing a QP must know to certify IMP batches for the release for clinical trials.
Background
The manufacture of investigational medicinal products (IMPs), including labelling, packaging, testing and certification, is carried out in accordance with the applicable GMP regulations. However, this is not a routine process, since, among other things, manufacturing and packaging procedures might be different for each and every clinical trial. The Qualified Person (QP) must therefore consider these particularities and the GMP/GCP interface.
Programm
Principles of Clinical Trials
- Introduction to Clinical Trials
- Principles involved in:
- API and excipients
- Bulk manufacturing
- Packing and labelling
- QP Certification and batch release - Final Thoughts for the QP
Specific Legal Requirements for IMPs
- Definitions
- Clinical Trial Regulation 536/2014
- Clinical Trial Directive 2001/20/EC
- MD Regulation 2017/745
- IMP Guidelines (various)
- Content of phase appropriate QMS overview
GMP meets Clinical Trials – Differences between IMPs and Commercial Products
- Starting materials – Active pharmaceutical ingredient, excipient, diluent / reconstitution media
- Bulk
- Placebo
- Comparator
- Auxiliary Medicinal Product AxMP
- Trial design, randomization
- Order
- Blinding principles
- Packaging Scenarios
- Labelling
- Exemptions from the manufacturing authorization for packaging & labelling
- Future concepts
IMP Batch Confirmation, QP Certification and IMP Release
- Definitions / Regulations / Guidelines
- IMP Release Process
- Distribution Concept / Controlled Shipment of IMPs
GMP/ GDP/ GCP Interface
- Reconstitution
- Pre-requisites for randomisation and blinding
- Distribution
- Stability and shelf-life extensions
- Trial Master File
- Site to site transfers
- Complaints and recall
- End of study
- Where does QP responsibility end?
Weitere Informationen
Venue
Barceló Hotel Hamburg
Ferdinandstrasse 15
20095 Hamburg, Germany
+49 (0)40 22 63 62 0
Barceló Hotel Hamburg
Ferdinandstrasse 15
20095 Hamburg, Germany
+49 (0)40 22 63 62 0
Accommodation
CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. 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.
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.
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.
Fees (per delegate plus VAT)
Pre-course Session: IMP QP Education Course
QP Association Members € 1,090
ECA Members € 1,090
Non-ECA/Non-QP Association Members € 1,290
EU GMP Inspectorates € 645
QP Association Members € 1,090
ECA Members € 1,090
Non-ECA/Non-QP Association Members € 1,290
EU GMP Inspectorates € 645
QP Education Course
QP Association Members € 1,890
ECA Members € 1,890
Non-ECA/Non-QP Association Members € 2,090
EU GMP Inspectorates € 1,045
QP Association Members € 1,890
ECA Members € 1,890
Non-ECA/Non-QP Association Members € 2,090
EU GMP Inspectorates € 1,045
Save money when booking both events. We offer you a discount of 400€ if you will book both training courses.
The conference fee is payable in advance after receipt of invoice and includes dinner on Wednesday, lunch on all conference days and all refreshments. VAT is reclaimable.
The conference fee is payable in advance after receipt of invoice and includes dinner on Wednesday, lunch on all conference days and all refreshments. VAT is reclaimable.
Contacts
Questions regarding content:
Mr Wolfgang Schmitt, +49 (0)6221 84 44 39, w.schmitt@concept-heidelberg.de
Questions regarding organisation:
Ms Marion Grimm, +49 (0)6221 84 44 18, marion.grimm@concept-heidelberg.de
Datum & Uhrzeiten
Tue, 10 March 2026, 09-17:45 h
Teilnahmegebühr
| ECA-Member*: | € 1090,- |
| Regular Fee*: | € 1290,- |
| EU/GMP Inspectorates*: | € 645,- |
| QP Member Discount*: | € 1090,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
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E-Mail: info@concept-heidelberg.de
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