Dr Susanne Ding
Boehringer Ingelheim Pharma
Referierende
Dr Sue Mann
Sue Mann Consultancy
Patryk Jegorow
Takeda
A discount of EUR 400 applies when booking the QP Education Course Module A together with the IMP pre-course session.
Highlights:
- Legal Background
- Tasks and responsibilities
- Liability and indemnification
- Tasks and responsibilities
- Liability and indemnification
Zielgruppe
New colleagues becoming IMP QPs, QPs looking for continuous training and personnel of CROs and “non-commercial” IMP organisations.
Zielsetzung
Dear Colleagues,
The European Qualified Person Association (EQPA) has developed two Education Course Modules for new, trainee and practising Qualified Persons to address general compulsory and regulatory issues. This Module A has been compiled by the EQPA Board of Directors to provide a general idea of the special tasks and responsibilities of a QP, but also to discuss and convey possible solutions to problems addressed in case studies and workshops. How to master the QP role in practice including interfaces and interactions is a central topic of Module B.
Broaden and intensify your knowledge of the Qualified Person’s duties and responsibilities. Experts from the EQPA Board of Directors, pharmaceutical industry and regulatory authority will share their experience on important issues of the QP’s daily business and will give first-hand information on current and future expectations.
Further impacts of the latest developments, specific tasks and further discussions will be part of the annual QP Forum of the European Qualified Person Association.
Best regards,
Ulrich Kissel,
Chairman of the European Qualified Person Association
Moderator
Wolfgang Schmitt, on behalf of EQPA
Wolfgang Schmitt, on behalf of EQPA
Programm
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.
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
Date
Tuesday, 09 March 2027, 09:00–17:45 h
(Registration and coffee 08:30–09:00 h)
(Registration and coffee 08:30–09:00 h)
Venue
Barceló Sants Hotel
Plaça dels Països Catalans, s/n
08014 Barcelona, Spain
+34 (93) 503 53 00
sants@barcelo.com
Barceló Sants Hotel
Plaça dels Països Catalans, s/n
08014 Barcelona, Spain
+34 (93) 503 53 00
sants@barcelo.com
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. 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.
Fees (per delegate plus VAT)
QP Association Members EUR 1,090
ECA Members EUR 1,090
Non-ECA/Non-QP Association Members EUR 1,290
EU GMP Inspectorates EUR 645
ECA Members EUR 1,090
Non-ECA/Non-QP Association Members EUR 1,290
EU GMP Inspectorates EUR 645
Save money when booking both events. A discount of EUR 400 applies when booking the QP Education Course Module together with the IMP pre-course session.
The conference fee is payable in advance after receipt of invoice and includes lunch on all conference days and all refreshments. VAT is reclaimable.
The conference fee is payable in advance after receipt of invoice and includes 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, 09 March 2027, 09:00–17:45 h
(Registration 08:30–09:00 h)
Teilnahmegebühr
| ECA-Member*: | € 1090,- |
| Regular Fee*: | € 1290,- |
| EU/GMP Inspectorates*: | € 645,- |
| European 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
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
Für Lieferanten: Ausstellungs- und Sponsoringmöglichkeiten
Teilnehmerstimmen - das sagen andere über unsere Seminare:
