Mission and Vision. ISPE Nordic PAT COP Marts Jesper Wagner, AN GROUP A/S, Mejeribakken 8, 3540 Lynge, Denmark

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1 Mission and Vision ISPE Nordic PAT COP Marts 2007

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

2 Mission Statement To 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 Page 2

Mission Statement Provide a coordinated communication route from its members to and from all external parties (eg regulatory bodies, advisory boards, workshops, courses and speakers) Provide

3 Mission Statement Provide 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 guidelines Efficient time management for its membership, by specifically providing a platform for: workshops, courses, symposiums, and speakers for members within Scandinavia Exchange of knowledge with healthcare and non-healthcare professionals Page 3

4 Charter Membership The group is open to all interested parties Industry Types To recognise the diverse types of industry that the group should serve, the following industries should be covered: Biotechnology Medical Devices Pharmaceutical API Excipients Packaging Relationships with non-healthcare industries Page 4

5 Management - Core group Current chair Mette Bryder, Lundbeck A/S Current Steering Committee David Karlsson, McNeil AB Connie Langberg Heinze, Novo Nordisk A/S Gert Ragnarsson, Medical Products Agency/EMEA Jan Gustafsson, ISPE/Novo Nordisk A/S Jesper Wagner, AN GROUP A/S Per Vase, NNE A/S Rasmus Bro, KU Page 5

6 ISPE Nordic PAT CoP Activities update Nov 2006: Workshop in Gothenburg Joint event between the ISPE Nordic PAT CoP and EUFEPS (European Federation for Pharmaceutical Sciences) Dec 2006: Steering Committee Meeting Reconstituted the CoP with New Chair and a supporting steering committee Jan 2007: Steering committee meeting Adjusted charter Page 6

7 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 Page 7

8 Structure of future meetings Nordic PAT COP meetings consists of 4 elements: Overview of the technical subject Technical subject Outline for discussion Discussion Meetings will take place every second month at a fixed location Page 8

9 Future activities within ISPE Nordic PAT CoP Result of Brainstorm in the steering committee: Training Annual PAT workshop Discuss and comment on ASTM E55 drafts og standards Contact to EMEA, FDA Review of guideline from DACH CoP Write ISPE application documents based on ASTM standards Page 9

10 Membership info Merged activities with the Danish LIF PAT Group Approximately 60 members from various companies: Consultant 29% Biotech 20% Pharmacutical 37% Supplyer 11% Goverment 3% Page 10

11 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, Arla 09:25-09:40 Practical Examples on PAT. Mette Bryder, Lundbeck A/S 09:40-09:55 How to get started with PAT. Alex Brindle, NNE A/S 09:55-10:05 Break Open discussion: PAT; A science and risk based approach with a large tool box 10:05-10:15 Science and Risk based approach. Metter Bryder, Lundbeck A/S 10:15-10:25 PAT tool box. Rasmus Bro, Department of Food Science 10:25-10:50 Open discussion. Chairman Mette Bryder, Lundbeck A/S 10:50-11:00 Subject, speakers and date for next meeting, Per Vase, NNE A/S Page 11

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Agenda Subject Time Status Annex Comments

Board Meeting - Draft Agenda Wednesday, January, 30 th From 15.00 to 20.00 19.30: Dinner Agenda 1, Annex 01 Agenda Subject Time Status Annex Comments 1. Welcome and approval of the agenda 15.00 15.10 01