Added value of Combination Products
“delivery of innovative treatment”
With table top exhibition
When :
Thursday 19 November 2015
Location:
RE:flex
Schaliënhoevedreef 20T
2800 Mechelen
A visit of Biocartis NV will be organised in the afternoon
Table tops will be accessible during the seminar
*Combination Products are defined in 21 CFR 3.2(e)
Added value of Combination Products
8:00 - 9:00
Registration and Coffee
9:00 - 9:15
Welcome – Why did we select the topic “Combination products”
(Leo Versteynen, ISPE Belgium)
9:15 - 9:30
Keynote : Trends in health care and MDx and where Biocartis fits in
(Hilde Windels, Biocartis)
9:30 – 10:05
Personal Health Care : fitting the treatment to the patient
(Dr. Carlo Lannicola, Roche)
10:05 - 10:40
Combination Products Trends & Technologies
(Andrew Koubatis, Altran)
10:40 - 11:10
Coffee Break with Table Top & Networking Opportunities
11:10 -11:45
How to transfer CP regulations into organizational processes
(Andreas Ries & Roland Limbeck, Vetter Pharma)
11:45 - 12:20
Implementing 21 CFR Part 4 Current Good Manufacturing Practice Requirement for
Combination Products, Design Controls at Janssen Pharmaceutical.
(Dolores Perez, J&J)
12:20-13:40
Lunch with Table Top & Networking Opportunities
13:40 -14:15
The Evolving and Challenging Regulatory Landscape for Combination Products
(Tangy Coradin, BD Medical)
14:15 -14:50
Combination Product impact on supplier management process and procedure
(Dolores Perez, J&J)
14:50 -15:20
Biocartis, pushing the boundaries of innovation in an open platform model
(Sandra Marguillier & Hilde Windels & Luc Van Dijck, Biocartis)
15:20 -15:30
Closing
15:30 -17:10
Site Visit Biocartis
(Sandra Marguillier & Hilde Windels & Luc Van Dijck, Biocartis)
17:10-19:00
Closing of the Day with Networking Reception
Added value of Combination Products
Abstracts
Personal Health Care : fitting the treatment to the patient. (Dr. Carlo lannicola)
The presentation will discuss Roche’s Personalised Healthcare strategy, which aims at providing medicines and diagnostic tools that
enable tangible improvements in the health, quality of life and survival of patients.
Combination Products Trends & Technologies. (Andrew Koubatis)
The pharmaceutical industry is facing unprecedented challenges to deliver new and innovative treatments for disease and chronic
conditions. Andrew Koubatis, Altran, will describe how new and low cost technologies provide a wealth of opportunities for better
management and treatment of diseases.
How to transfer CP regulations into organizational processes - the perspective of a CDMO. (Andreas Ries –
Roland Limbeck)
CP regulations (overview) ; How to design processes in an organisation to meet CP requirements ? ; Which key processes are in the
focus ? ; Which milestone have to be set ? ; Which business units are especially affected by the regulation ?
Implementing 21 CFR Part 4 Current Good Manufacturing Practice Requirements for Combination
Products, Design Controls at Janssen Pharmaceutical. (Dolores Perez)
The presentation will detail the process that Janssen has used to implement Part 4 requirements for Combination Products in the
Pharma environment. This will cover defining what a combination product is and the deliverables expected for combination products.
The intent is to provide the audience with an understanding of these requirements and the challenges of implementing these
requirements in a Pharma environment.
The Evolving and Challenging Regulatory Landscape for Combination Products - BDM-PS Agile Solutions
to Streamline Regulatory Approvals. (Tanguy Coradin)
The container closure system of parenteral pharmaceuticals has now a critical role from early development to registration. The recent
FDA rule for combination products being of course the most well-known regulation, requirements from Health Authorities are actually
changing and increasing in Europe and Japan too.
This presentation will give you insights into recent evolutions of the US, EU and Japan regulations having a major impact on your
activity. Key examples will show you how Health Authorities are more and more demanding in term of design control data and of early
consideration of the user and patient needs as enacted in Human Factors requirements.
Considering this new paradigm, you will see how the set of customized regulatory solutions that BD Medical - Pharmaceutical Systems
has developed based on our long-lasting experience is aligned with your specific needs. You will also realize how this partnership with
your supplier of container closure system components is essential to ensure an optimized development of your combination product
and to secure your time to market.
Combination Product impact on supplier management process and procedure. (Dolores Perez)
The presentation will detail the impact and the process that Janssen has used to implement Part 4 Purchasing Control requirements
for Combination Products in the Pharma environment. This will define the requirements expected for combination products and provide
the audience with an understanding of these requirements and the challenges of implementing these requirements in a Pharma
environment.
Biocartis, pushing the boundaries of innovation in an open platform model. (Hilde Windels, Sandra Marguillier &
Luc Van Dijck)
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The power of the Idylla platform
Focus on innovation in oncology and infection diseases
Introduction to the Biocartis visit
Added value of Combination Products
Who should attend?
All stakeholders responsible for:
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Manufacturing & Quality Control
Technology & Engineering & Automation
Logistics & Distribution
Supply Chain
Regulatory, validation, QA & GMP
and active in:
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Pharmaceuticals
Biopharmaceuticals
Biologics
API
And related Life Science industries…
Registration
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Open for ISPE Members or Non-ISPE Members
Registration required (before 13 November) via website : link
Including Lunch and Networking
Price :
 275 € (for ISPE member)
 75 € (for ISPE member – Young Professional (age under 30))
 495 € (for Non ISPE Member, including 1 year membership)
 295 € (for Non ISPE member – Young Professional (age under 30), including 1 year membership)
See registration website for payment details.
Contact : ISPEbelgium@aim.com
 ISPE reserves the right to delay the meeting and modify the program and the place, in case of force majeure.
 Any cancellation received later than one week before the event will not be credited.
Added value of Combination Products
Added value of Combination Products
Table Tops