Sprecher
Susanne Ding, Boehringer Ingelheim, Germany
Dr Ulrich Kissel, European QP Association
Savvas Koulouridas, Fagron BV, The Netherlands
Aidan Madden, FivePharma, Ireland
Sue Mann, Sue Mann Consultancy, U.K.
Rico Schulze, State Ministry of Social Affairs and Consumer Protection, Saxony, Germany
Lance Smallshaw, UCB, Belgium
Brenda Van Assche, Janssen, Belgium
Dr Ulrich Kissel, European QP Association
Savvas Koulouridas, Fagron BV, The Netherlands
Aidan Madden, FivePharma, Ireland
Sue Mann, Sue Mann Consultancy, U.K.
Rico Schulze, State Ministry of Social Affairs and Consumer Protection, Saxony, Germany
Lance Smallshaw, UCB, Belgium
Brenda Van Assche, Janssen, Belgium
Zielsetzung
Pre-course IMP 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.
QP 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.
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
Pre-course IMP 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 take into account these particularities and the GMP/GCP interface.
QP 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.
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 take into account these particularities and the GMP/GCP interface.
QP 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
Pre-course IMP Session:
New colleagues becoming IMP QPs, QPs looking for continuous training and personnel of CROs and “non-commercial” IMP organisations.
QP 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.
New colleagues becoming IMP QPs, QPs looking for continuous training and personnel of CROs and “non-commercial” IMP organisations.
QP 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
Pre-course IMP Session:
General introduction
General introduction
- Different clinical phases I to IV, focus on patient safety
- Undefined processes (manufacture, fit for purpose control strategy, etc.)
- Why use risk assessments & how to apply – vital core of a IMP quality system
- Diversity: IMP manufacturers, start-ups, academia…
Specific legal requirements for IMPs
- Clinical Trial Regulation EU No. 536/2014 and the “old” Annex 13 and Directives 2001/20/EC and 2003/94/C
- The “new” ATMP regulation
GMP meets clinical trials – Differences between IMPs and commercial Products
- Packaging & labeling
- Randomization
- Blinding / placebos
- Comparators
- NIMPs / AMPs
- Where to apply validation activities
- The Product Specification File (PSF)
- 3rd country manufacture of IMPs: import and the QP Declaration
Registration
- IMPD, CTA, IND etc.
- Regulatory compliance and the two step release procedure
GMP/ GDP/ GCP Interface
- Interaction with clinical sites
- Distribution
- IRT
QP Education Course:
The Legal and Professional Duties of the Qualified Person
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:
Certification by a QP and Batch Release - to certify or not, that’s the Question
Certification by a QP and Batch Release - to certify or not, that’s the Question
- Batch release: degrees of freedom and limits
- Batch deviations and QP Certification
- Case Studies
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:
Deviations during the Manufacture of an API – What Actions should you take as the responsible QP?
What the QP needs to know regarding the Supply Chain (from Supplier Qualification to GDP)
Deviations during the Manufacture of an API – What Actions should you take as the responsible 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
- Batch certification and release
- Laboratory investigations
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: 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
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