Dr Ulrich Kissel
European QP Association (EQPA), KisselPharmaConsulting
Referierende
Dr Susanne Ding
Boehringer Ingelheim Pharma
Dr Lance Smallshaw
UCB Biopharma SRL
Aidan Madden
FivePharma
Sue Mann
Sue Mann Consultancy
Savvas Koulouridas
Fagron BV
Patryk Jegorow
Takeda
Dr Julia Gudd
Ministry of Justice and Consumer Protection
With an optional pre-course Session: Investigational Medicinal Products (IMP) QP Education Course on 09 March 2027 (A discount of EUR 400 applies when booking both training courses together.)
Highlights:
- Legal Background
- Tasks and responsibilities
- Liability and indemnification
- Tasks and responsibilities
- Liability and indemnification
Zielgruppe
- New and future Qualified Persons
- QPs who are looking for ongoing training
- Personnel who want to get a detailed overview of the role and responsibilities of a QP
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
Programm
Programme Investigational Medicinal Product (IMP) Pre-Course Session
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)
- Concept of phase appropriate QMS oversight
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
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 for both Events
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.
Social Event
On 10 March, 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 10 March, 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.
Fees (per delegate plus VAT)
Pre-course Session: IMP QP Education Course
QP Association Members EUR 1,090
ECA Members EURO 1,090
Non-ECA/Non-QP Association Members EUR 1,290
EU GMP Inspectorates EUR 645
QP Association Members EUR 1,090
ECA Members EURO 1,090
Non-ECA/Non-QP Association Members EUR 1,290
EU GMP Inspectorates EUR 645
QP Education Course
QP Association Members EUR 1,890
ECA Members EUR 1,890
Non-ECA/Non-QP Association Members EUR 2,090
EU GMP Inspectorates EUR 1,045
QP Association Members EUR 1,890
ECA Members EUR 1,890
Non-ECA/Non-QP Association Members EUR 2,090
EU GMP Inspectorates EUR 1,045
Save money when booking both events. A discount of EUR 400 applies when booking both training Courses together.
The conference fee is payable in advance after receipt of invoice and includes dinner on the first day, 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 the first day, lunch on all conference days and all refreshments. VAT is reclaimable.
Contacts
Questions regarding organisation:
Ms Marion Grimm, +49 6221 84 44-18, marion.grimm@concept-heidelberg.de
Ms Marion Grimm, +49 6221 84 44-18, marion.grimm@concept-heidelberg.de
Datum & Uhrzeiten
Pre-course Session: IMP QP Education Course
Tue, 09 March 2027, 09:00–17:45 h
(Registration 08:30–09:00 h)
QP Education Course – Module A
Wed, 10 March 2027, 09:00–18:00 h
(Registration 08:30–09:00)
Thu, 10 March 2027, 08:30–15:30 h
Tue, 09 March 2027, 09:00–17:45 h
(Registration 08:30–09:00 h)
QP Education Course – Module A
Wed, 10 March 2027, 09:00–18:00 h
(Registration 08:30–09:00)
Thu, 10 March 2027, 08:30–15:30 h
Teilnahmegebühr
| ECA-Member*: | € 2580,- |
| Non ECA Member*: | € 2980,- |
| EU/GMP Inspectorates*: | € 1290,- |
| European QP Member Discount*: | € 2580,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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E-Mail: info@concept-heidelberg.de
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