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 Pharma
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.
Hintergrund
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.
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.
Programm
Gesamtes Programm als PDF herunterladen
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)
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 Qualified Person within the EU legislation and regulation framework
- Professional tasks, duties and responsibilities
- Expectations of an EU GMP Inspector
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
- Possible scenarios according to Annex 16
- Mutual Recognition Agreements (MRA)
- Documentation review issues
- The QP in the quality system
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
Workshop: What the QP needs to know about OOS/OOT
- Involvement of the QP
- Role and responsibility of the Head of Quality Control
- Responsibility of the QP
What the QP needs to know regarding the Supply Chain (from Supplier Qualification to GDP)
- The QP: ultimate responsibility for the supply-chain of a drug product?
- What is the expected scope of supply chain oversight
- Supply chain integrity
- Active Pharmaceutical Ingredient, Excipients, Bulk and Finished Product
- Shipping under quarantine, ship to label claim, importation testing
- The role of the QP in supplier qualification and auditing
- Written confirmation and QP Declaration
- GMP meets GDP: where does the responsibility end?
- The QP’s involvement in the recall process
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
- Role and responsibility of head of production and head of quality control (when things go wrong)
- Role and responsibility of upper management (when things go wrong)
- Delimitation of responsibilities with QPs in the same company
- Delimitation of responsibilities with QPs at a contractor
Workshop: Deviations during the Manufacture of an API – What Actions should you take as the responsible QP?
| ECA-Member*: | € 2190,- |
| Non ECA Member*: | € 2490,- |
| EU/GMP Inspectorates*: | € 1245,- |
| QP Member Discount*: | € 2190,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
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