Canice Kearney
Takeda Ireland
Referent:innen
Dr Sue Mann
Sue Mann Consultancy
Energy Kristina Hansen
MilCor Consulting
Jette Petersen
F. Hoffmann-La Roche
What MAHs and Virtual Companies need to know
Zielgruppe
QA Managers and Executives from MAHs/Virtual Companies including Senior Management and Business Executives and those involved in improving the Pharmaceutical Quality System.
Zielsetzung
Hear and discuss the expectations and best practices for effective and efficient Contract Manufacturing Organisations (CMO) Quality and Supply Chain Oversight processes and how to get there. This will support you turning your company’s quality excellence goals into reality.
Background
Marketing Authorisation Holders (MAHs) but also innovative Start-Ups and Research & Development organisations outsource parts, if not all, of manufacturing, testing and distribution activities for their product(s).
There are some good reasons for such an approach. It gives smaller organisations the opportunity to bring their own product(s) to the market and keep the focus on research and development and it also helps attracting investors. The actual employees can concentrate on core competencies. For larger companies, it offers more flexibility, focus on core competences and a good way to quickly add new products to the portfolio and develop markets faster.
Of course, such a business model also brings some challenges. The contract giver needs a high degree of trust with the business partners in the supply chain, must be able to deal with differences in corporate and quality culture and, above all, have the necessary oversight of the quality and supply chain of all activities and products.
Just as it is with other business areas, management has the responsibility to ensure that systems are in place to effectively monitor the state of control in order to intervene with timely decisions to manage risk, achieve goals, and add stakeholder value. It is of utmost importance to detect and heed possible problems early enough.
There are some good reasons for such an approach. It gives smaller organisations the opportunity to bring their own product(s) to the market and keep the focus on research and development and it also helps attracting investors. The actual employees can concentrate on core competencies. For larger companies, it offers more flexibility, focus on core competences and a good way to quickly add new products to the portfolio and develop markets faster.
Of course, such a business model also brings some challenges. The contract giver needs a high degree of trust with the business partners in the supply chain, must be able to deal with differences in corporate and quality culture and, above all, have the necessary oversight of the quality and supply chain of all activities and products.
Just as it is with other business areas, management has the responsibility to ensure that systems are in place to effectively monitor the state of control in order to intervene with timely decisions to manage risk, achieve goals, and add stakeholder value. It is of utmost importance to detect and heed possible problems early enough.
Programm
Regulatory Background and Requirements
- What does ‘Oversight’ mean?
- Applicable GMP requirements when working with CMOs
- Which are the essential Pharmaceutical Quality Systems (PQS) elements?
Marketing Authorisation Holder (MAH) Responsibilities
- The ultimate responsibility for the performance of a medicinal product
- Articulating MAH responsibilities in a complex organization
- Effective MAH governance
Quality and Supply Chain Oversight when working with CMOs – what is different and what are the Challenges?
- What does CMO oversight mean and what is expected?
- What aspects of the supply chain are relevant and how is sufficient oversight achieved?
- How to handle more than one quality system
- How to manage differences in culture and language
Supply Chain Maps – Examples of Complexities involved
- What is required of a Supply Chain Map (SCM)?
- Control and format of SCMs and setting the scope of responsibilities
- Achieving value from use of SCMs – and aligning company’s approach for supply
Interactive Session: What is needed in your Organisation?
(Specific Quality System Aspects)
(Specific Quality System Aspects)
- How the PQS should interact with other companies’ Systems
- Detailed review of possible points of interaction (e.g. change controls, deviations/non-conformances, complaints & recall, preparation of the Product Quality Review, audits……)
- How to ensure effective and efficient interaction and communication.
- What are the challenges to overcome?
Batch Certification – Minimum Requirements & Best Practices
- Arrangements for QP Certification at the contract giver
- Manage deviation reporting and change control implementation
- Batch Certification – Considerations for outsourcing
- Case studies, examples of effective arrangements
Case Study IMPs: CDMO Oversight at Roche
- Responsibilities
- Contract Development and Manufacturing Organisations (CDMO) selection and Control
- Overview Management
- Point of contacts
- Reviews and quality reports (external/ internal)
Dealing with difficult CMO Stakeholder Behaviour
- Top 10 most difficult behaviours to handle
- Reasons
- How to increase engagement
CMOs needing high Level of Oversight
- Triggers, figures and stickers
- Handling below satisfactory CMOs
Use of Quality Risk Management (QRM)
- Objective of QRM and how best to use this tool
- When to use QRM proactively and how to ensure this is effective
- Examples of when QRM has to be used reactively and how to make informed, scientific decisions
Post Product Release Oversight Responsibilities
- MAH’s responsibilities after certification and release of medicinal product
- Establishing arrangements for effectively managing defect reporting, potential market actions, supervisory authority engagement
The GDP Interface
- Reminder of GDP guidance available for APIs and products
- How this interface should work to ensure product reaches patient in suitable condition
- Challenges to overcome
Weitere Informationen
Venue
HYPERION Hotel Berlin
Prager Straße 12
10779 Berlin, Germany
+49 (0)30 236250 0
hyperion.berlin@h-hotels.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 the evening of the first course day, you are cordially invited to a social event (city tour and dinner). This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Fees (per delegate, plus VAT)
ECA Members € 1,890
APIC Members € 1,990
Non-ECA Members € 2,090
EU GMP Inspectorates € 1,045
The course fee is payable in advance after receipt of invoice and includes dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable.
Conference language
The official conference language will be English.
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.
Contacts
Questions regarding content:
Mr Wolfgang Schmitt, +49 (0)6221 84 44 39, w.schmitt@concept-heidelberg.de
Questions regarding organisation:
Ms Isabell Helm, +49 (0)6221 84 44 49, helm@concept-heidelberg.de
Datum & Uhrzeiten
Wed, 10 Dec 2025, 9–17:15 h
Thu, 11 Dec 2025, 8:30–15:15 h
Thu, 11 Dec 2025, 8:30–15:15 h
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager"
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E-Mail: info@concept-heidelberg.de
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