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| Leachables and Extractables 2008 Conference
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Leachables
and Extractables
5-6 March 2008, The Gresham Hotel, Dublin
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Register
Now
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Media
Sponsor
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Pharmaceutical packaging
fulfils a number of functions: maintaining the integrity of a drug, containing
and preserving product ingredients at their listed concentrations until the
expiration date, maintaining the original purity of the drug, and delivering
and dispensing the drug.
However, the rubber and
plastic components used in medical products and devices can also pose a serious
threat to patient safety as they have the potential to interact with the dosage
form. In recent years there has been an increasing importance placed on the
examination of leachables and extractables that may arise from components used
in, for example, primary container and closure systems, self-adhesive labels
or secondary packaging materials. Extractables include chemical species that
migrate from packaging materials or other components under exaggerated solvent,
temperature, and time conditions. Leachables, on the other hand, are chemical
species that migrate under normal conditions.
However, the regulatory
landscape is changing: the PQRI (Product Quality Research Institute) Leachables
and Extractables Working Group has submitted best practice guidelines to the
PQRI Drug Product Technical Committee and the US Food and Drug Administration
(FDA), establishing recommended safety evaluation thresholds which have been
justified from a toxicological or safety perspective.
Material selection for
pharmaceutical packaging must include thorough screening for leachables and
extractables in order to ensure compatibility in drug- package combinations.
If you supply plastics to the pharmaceutical industry or you’re a pharmaceutical
manufacturer you’ll be more than aware of the PQRI and FDA regulations
on leachables and extractables. But are you confident that you comply with the
regulator’s requirements?
This conference
has been designed to bring together the pharmaceutical supply chain to discuss
the latest research and development in minimising the risk posed by leachables
and extractables. Whether you deal with parenterals, implantables, inhalers
or solid dose packaging, this conference covers it all.
TECHNICAL
PROGRAMME
Wednesday
5 March 2008
08.30 REGISTRATION
AND COFFEE
09.25 Welcome and
Introduction to Leachables & Extractables 2008
Session
1: Materials
09.30 Additives
in and polymer processing of pharmaceutical packaging
Dr Paul Shipton, Plastics Consultancy Services, UK
Session
2: Regulatory Landscape
10.00 The competent
authority view - TBC
10.30 Leachables
and extractables: regulatory issues in the medical device industry
Ron Pagan, Medicom Consulting Ltd, Ireland
11.15 COFFEE
Session
3: Best Practice Guidelines
11.45 PQRI: safety
thresholds and best practices for extractables and leachables in orally inhaled
and nasal drug products
Douglas J Ball, MS, DABT, Pfizer Inc, USA
12.15 The analytical
evaluation threshold (AET) concept and current limits of quantitation
James D Mullis, Boehringer Ingelheim Pharmaceuticals Inc, USA
13.00 LUNCH
14.30 Extractables
and leachables best practice guidelines
Keith Scott, Smithers Rapra Technology Ltd, UK
15.00 Meeting the
challenges of implementing PQRI guidelines with respect to routine extractables
methods for OINDP in a high volume manufacturing environment
Stuart Pattinson & John Colwell, Bespak Europe Ltd, UK
Session
5: Approaches to Leachables & Extractables Testing: Case Studies
15.30 Analytical
methods for extractables and leachables studies: case studies
Dr Michael Jahn, Ciba Speciality Chemicals Inc, Switzerland
16.00 COFFEE
16.30 Analytical
approaches for extractable and leachable testing
Dr Andrew Feilden, Astrazeneca, UK
17.00 Extractables
and leachables for pharmaceutical products: a practical approach
Dipl-Ing Heike Schulz, West Pharmaceutical Services Deutschland GmbH, Germany
17.30 END OF DAY
ONE
18.30 EVENING DRINKS
RECEPTION
Thursday 6 March 2008
09.00 COFFEE
Session
6: Quality
09.30 Managing
hybrid quality systems
Diane Baker, Smithers Rapra Technology Ltd, UK
Session
7: Supply Chain Considerations
10.00 Points to
consider on extractables and leachables during OINDP development
Dr Andy Rignall, Astrazeneca, UK
10.30 Resin manufacturer’s
perspective on pharmaceutical industries’ packaging needs to comply with
extractables and leachables legislation
Hanneli Seppanen, Borealis Polymers OY, Finland
11.00 COFFEE
11.30 A strategy
for extractives and leachables evaluation to minimise risk when changing materials
in primary packaging components
Simon Bailey, Sanofi Aventis, UK
12.00 Innovative
thermoplastic materials for healthcare applications
Rob de Jong, Sabic Innovative Plastics, The Netherlands
12.30 LUNCH
14.00 Optimisation
of sampling from a plastic material for extractables testing
Stephane Burel, Valois, France
Session
8: Case Studies
14.30 Metered dose
inhaler extractable and leachable study designs
Graham Wilson, GlaxoSmithKline Research & Development, UK
15.00 COFFEE
15.30 A case example
of leachable and extractable testing for containers used for veterinary products
Cathlyn Carley, Novartis Animal Health, Switzerland
16.00 Material
and product evaluation
Maygon Wendel Lesenius, Gambro AB, Sweden
16.30 END OF CONFERENCE
Conference
Language
Please note that the conference will be conducted in English.
Who Should
Attend?
- Pharmaceutical,
packaging and medical device companies
- Raw material
suppliers
- Suppliers of
pharmaceutical processing equipment
Early Registration
Offers
Register before 5 January 2008 to take advantage of the special Early Bird Discount
registration fee.
Companies sending
one or two delegates
€850 + VAT at 21% per delegate before 5 January 2008
€1050 + VAT at 21% per delegate after 5 January 2008
Companies
sending three or more delegates
€750 + VAT at 21% per delegate before 5 January 2008
€950 + VAT at 21% per delegate after 5 January 2008
Registration includes
a copy of the proceedings, lunches and refreshments during the day.
Please send registration
enquiries to Sharon Garrington, Conference Organiser. Email sgarrington@rapra.net
Tel: +44 (0) 1939 250283; Fax: +44 (0) 1939 252416
Conference
Venue
The conference will be held at:
The Gresham Hotel
23 Upr. O'Connell St.
Dublin 1. Ireland
Tel: +353-1-874 6881
Fax: +353-1-878 7175
Located on O'Connell
Street, in the heart of Dublin City Centre, the deluxe 4 star Gresham Hotel
is within minutes walk from The River Liffey, Temple Bar, the IFSC and the shopping
districts of the city making it the ideal location for your business or leisure
needs.
The Gresham Hotel
is a Dublin institution and is known throughout the world. This landmark building,
in Dublin's City Centre, has recently been refurbished, successfully marrying
the traditional styles of The Gresham with the contemporary style of the 21st
Century.
Hotel Reservations
Please send reservation enquiries to Sharon Garrington, Conference Organiser,
email: conferences@rapra.net. A booking
form will be sent with your joining instructions on receipt of your completed
registration form.
Alternatively please
use the following link to access the online accommodation booking form and click
on the button in the “delegates” box
http://www.pacific7.co.uk/index.php
Exhibition
& Sponsorship
A limited number of cost effective sponsorship opportunities are available to
maximise your corporate profile at this important event. To receive further
information please contact the conference department, conferences@rapra.net
Tel +44(0)1939 250383 Fax +44(0)1939 252416.
- Wallet service
costs €750 + VAT at 21% to insert a pen or leaflet in delegate packs
(up to 6 A4 pages),
- Tabletop exhibition
costs from €2000 + VAT at 21% (including one delegate place)
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