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ISPE Nordic PAT COPMarts 2007

Mission and Vision

Jesper Wagner, AN GROUP A/S, Mejeribakken 8, 3540 Lynge, Denmark


Mission StatementTo provide a professional technical group to support all levels of competence of Process Analytical Technology within the Scandinavian region

Members shall be welcomed from the industry (pharmaceutical, food, biotechnology, medical devices etc), academia, regulators & suppliers industries


Mission StatementProvide a coordinated communication route from its members to and from all external parties (eg regulatory bodies, advisory boards, workshops, courses and speakers)Provide opportunity for discussions and reviews of technical guidelinesEfficient time management for its membership, by specifically providing a platform for: workshops, courses, symposiums, and speakers formembers within ScandinaviaExchange of knowledge with healthcare and non-healthcare professionals


CharterMembership

The group is open to all interested partiesIndustry Types

To recognise the diverse types of industry that the group shouldserve, the following industries should be covered:

BiotechnologyMedical DevicesPharmaceuticalAPIExcipientsPackagingRelationships with non-healthcare industries


Management - Core group

Current chairMette Bryder, Lundbeck A/S

Current Steering Committee David Karlsson, McNeil ABConnie Langberg Heinze, Novo Nordisk A/SGert Ragnarsson, Medical Products Agency/EMEAJan Gustafsson, ISPE/Novo Nordisk A/S Jesper Wagner, AN GROUP A/S Per Vase, NNE A/SRasmus Bro, KU


ISPE Nordic PAT CoP Activities updateNov 2006: Workshop in Gothenburg

Joint event between the ISPE Nordic PAT CoP and EUFEPS (European Federation for Pharmaceutical Sciences)

Dec 2006: Steering Committee MeetingReconstituted the CoP with New Chair and a supporting steering committee

Jan 2007: Steering committee meeting Adjusted charter


Purpose of ISPE Nordic CoP meetings

Be a forum for People with special interest and or experience in PAT with the purpose of stimulating the use of PAT tools in the Nordic region

Important that participants will benefit from the meetings and gain knowledge, no matter of competence level

The meeting will be structured with presentations and discussions targeting different competence levels


Structure of future meetingsNordic PAT COP meetings consists of 4 elements:

Overview of the technical subjectTechnical subjectOutline for discussionDiscussion

Meetings will take place every second month at a fixed location


Future activities within ISPE Nordic PAT CoPResult of Brainstorm in the steering committee:

TrainingAnnual PAT workshopDiscuss and comment on ASTM E55 drafts og standardsContact to EMEA, FDA Review of guideline from DACH CoPWrite ISPE application documents based on ASTM standards


Membership infoMerged activities with the Danish LIF PAT Group

Approximately 60 members from various companies:

Consultant 29%Biotech 20%Pharmacutical 37%Supplyer 11%Goverment 3%


Agenda

09:00-09:10 Welcome, Vision of ISPE Nordic PAT COP Jesper Wagner, AN GROUP A/S

Technical presentations:09:10-09:25 PAT tools in the Food Industry. Julie Lundtoft Johnsen, Arla09:25-09:40 Practical Examples on PAT. Mette Bryder, Lundbeck A/S09:40-09:55 How to get started with PAT. Alex Brindle, NNE A/S09:55-10:05 BreakOpen discussion: PAT; A science and risk based approach with a large tool box10:05-10:15 Science and Risk based approach. Metter Bryder, Lundbeck A/S10:15-10:25 PAT tool box. Rasmus Bro, Department of Food Science10:25-10:50 Open discussion. Chairman Mette Bryder, Lundbeck A/S10:50-11:00 Subject, speakers and date for next meeting, Per Vase, NNE A/S

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