Dr Sue Mann
Sue Mann Consultancy
Referent:innen
Dr Susanne Ding
Boehringer Ingelheim Pharma
Dr. Julia Gudd
Behörde für Justiz und Verbraucherschutz (BJV)
Patryk Jegorow
Takeda
Dr Ulrich Kissel
European QP Association (EQPA), KisselPharmaConsulting
Savvas Koulouridas
Fagron BV
Aidan Madden
FivePharma
Dr Lance Smallshaw
UCB Biopharma SRL
We offer you a discount of 400 Euro if you will book both training courses. (QP Education Course & Pre-Course Session IMPs)
Zielgruppe
IMP Pre-Course Session
New colleagues becoming IMP QPs, QPs looking for continuous training and personnel of CROs and “non-commercial” IMP organisations.
Qualified Person Education Course
New and future Qualified Persons, QPs who are looking for ongoing training and personnel who want to get a detailed overview of the role and responsibilities of a QP.
Zielsetzung
IMP Pre-Course Session
This pre-course session provides a detailed overview of the basic and specific characteristics in IMP manufacturing a QP must know to certify IMP batches for the release for clinical trials.
Qualified Person Education Course
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.
BACKGROUND
IMP Pre-Course Session
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.
Qualified Person Education Course
Over the last years the role and responsibilities of the Qualified Persons have been increasing considerably. As a key person in the company, the QP has to consider many issues and has to take up the challenges within its areas of responsibilities. Additionally, as laid out in Article 49 of the European Directive 2001/83/EC, the QP needs to be highly qualified and experienced. This education course is one important part to help the QP be on top of current developments in GMP and regulatory requirements.
Programm
Programme Pre-Course Session: Investigational Medicinal Products (IMP) QP Education Course
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?
*******************************************************
Programme QP Education Course Module A
The Legal and Professional Duties of the Qualified Person
- The EU legislation and regulation Framework
- Requirements for becoming a QP
- Role and duties of a QP
Update on European Requirements
- EU GMP Guide Chapters
- EU GMP Guide Annexes
- Other important News
- What the QP needs to be aware of
Delegation of Duties and Responsibilities
- Duties and responsibilities of a QP (summary)
- Delegation of duties and responsibilities
- Annex 16
- Importation
- Assessments by others - Summary
Workshop on Case Studies: QP Discretion and Batch Certification
- Batch certification: degrees of freedom and limits
- Batch deviations and QP Certification: To certify or not, that’s the question
What the QP needs to know about Pharmacopoeias
- The world of different Pharmacopoeias
- Pharmacopoeias are more than just Monographs
- How to deal with different methods
The role of QC and QA in Release (Presentation and Workshop)
- Basic, common, and advanced release concepts including QC and QA
- Reflections on OOS/OOT
- Case studies
- Discussion of possible solutions
What the QP needs to know regarding the Supply Chain (from Supplier Qualification to GDP)
- Introduction to Supply Chains and expectations
- QP´s role in supplier qualification and auditing
- Written confirmation and QP Declaration
- GMP meets GDP: where does the responsibility end?
- QP’s involvement in the recall process
- QP’s role in drug shortages
How the QP fits into the Quality Systems
- How much involvement is needed in systems like:
- Product Quality Review
- Inspection Management
- Batch Record Review
- CAPA
- Change Control
- Validation
- Complaints and recalls
Liability and Indemnification
- Liability and indemnification of QPs
- Responsibility in the pharmaceutical Industry
- Types of drug-related product liability Claims
- Advanced tips -trends in liability
- Examples (interactive part)
Workshop: Deviations during the Manufacture of an API – What Actions should you take as the responsible QP?
Weitere Informationen
Venue of both Events
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.
Social Event
On 11 March you are invited to take part in an evening programme. This is an excellent opportunity to share your experiences with the speakers and colleagues from other companies in a relaxed atmosphere.
On 11 March you are invited to take part in an evening programme. This is an excellent opportunity to share your experiences with the speakers and 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.
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 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
Pre-course Session - IMP QP Education Course:
Tue, 10 March 2026, 09:00 - 17:45 h
QP Education Course – Module A:
Wed, 11 March 2026, 09:00 – 18:00 h
Thu, 12 March 2026, 08:30 – 15:30 h
All times mentioned are CET.
Tue, 10 March 2026, 09:00 - 17:45 h
QP Education Course – Module A:
Wed, 11 March 2026, 09:00 – 18:00 h
Thu, 12 March 2026, 08:30 – 15:30 h
All times mentioned are CET.
Teilnahmegebühr
| ECA-Member*: | € 2580,- |
| Non ECA Member*: | € 2980,- |
| EU/GMP Inspectorates*: | € 1290,- |
| QP Member Discount*: | € 2580,- |
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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