Wednesday, June 21, 2017 —
We hereby invite you to the joint event of MedPharmPlast Europe and Toxikon on 28 - 29 June 2017 at Toxikon Europe in Leuven.Interested? Then register here.
PROGRAMME: 28 June 2017 - Toxikon Workshop on Material Characterisation
|10:00 - 10:30||Registration & Welcome Coffee|
|10:30 - 10:45||Welcome by MedPharmPlast Europe & Toxikon|
|10.45 - 11:15|| |
Compendial [EP/USP]: what’s new & changing?
|11:15 - 11:45|| |
What’s the additional information from an extractables study vs a compendial study?
|11:45 - 12:15|| |
A view from a Notified Body on Medical Device Regulations (chemical characterization)
|12:15 - 13:15||Networking Lunch|
|13:15 - 13:45|| |
Incorporation of compendial and extractables testing in the strategy of a raw material supplier
|13:45 - 14:15|| |
A case study from routine Compendial / Extractables testing
|14:15 - 15:00|| |
Chemical characterization of medical devices: what’s important and will be important?
|15:00 - 15:30|| |
Selection of materials and biocompatibility studies from the perspective of a starting medical device company
|15:30 - 16:00|| |
Development of the definition of Medical Grade
|16:00 - 17:00||Company visit & lab tour|
PROGRAMME: 29 June 2017 - MedPharmPlast Europe Conference 2017
|9:00 - 10:00||Registration & Welcome Coffee|
|10:00 - 10:15|| |
|10:15 - 10:45|| |
Change Control: can you meet regulations if you don’t manage material changes?
|10:45 - 11:15|| |
Applying Pharmacopeia and Chemical Characterization Testing on Medical Tubings
|11:15 - 11:45|| |
The use of Hazardous Phthalates in Medical Devices: a Report for the European Commission
|11:45 - 12:45||Networking Lunch|
|12:45 - 13:30|| |
Update on the implementation of the Medical Device Regulation
|13:30 - 14:00|| |
Risk to supply chain - threat from counterfeit
14:00 - 14:30
|14:30 - 15:00|| |
RecoMed – Recycling single use medical devices from hospitals
|15:00 - 15:30|| |
Developments in the Materials Section in the European Pharmacopoeia
To register for one or both of the days, please fill in the registration from here.
Toxikon Workshop - 28 June 2017: for free
MedPharmPlast Europe Conference - 29 June 2017: 200 EUR (excl. VAT)
MEETING DATE, TIME & VENUE
Wednesday & Thursday, 28 - 29 June 2017
We recommend the following two hotels in Leuven:
- Novotel Leuven Centrum, Vuurkruisenlaan 4, 3000 Leuven, Belgium
- Email: H3153-RE@accor.com
- Tel: +32 16 21 33 37
- ParkInn by Radisson, Martelarenlaan 36, 3010 Leuven, Belgium
We are looking forward to welcoming you to our joint event!
About MedPharmPlast Europe
MedPharmPlast Europe is a sector group of EuPC created in 2014 by and for companies involved in the whole supply chain of plastic medical devices and pharmaceutical packaging in Europe. It assists companies in these industry sectors by keeping them informed about the latest developments in European regulations and their impact on the medical device and pharmaceutical packaging plastics value chain. MedPharmPlast Europe also represents the interests of the industry to the European legislators and tries to arrive at regulations that are both workable and protect the patient.
About Toxikon Europe
Toxikon Europe, an FDA registered and ISO 17025 accredited CRO, contracts and partners with Pharmaceutical, Biotech and Medical Device industries to deliver worldwide analytical and microbiological compliances and release testing.
Toxikon has great expertise in:
- Extractables and Leachables testing
- (Bio)Pharmaceutical services
- Microbiology services
- Medical Devices testing
It provides services with state-of-the-art equipment and the technical expertise of its people to generate timely reports with high quality data.