Complexity - Navigating International Challenges” ”Quality The 8th Scandinavian SARQA/DKG Quality Assurance Conference DATE: November 15th, 2018 VENUE: Malmö Arena Hotel, Hyllie (Malmö) The language of this conference is English Conference fee 1400 DKK/1900 SEK 08.30-09.15 Registration/Coffee breakfast buffet – 09.15-09.30 Welcome joint presentation SARQA and DKG – BREXIT and international collaboration between regulatory agencies 09.30-10:45 UK Perspective on BREXIT Title and presenter awaiting confirmation International collaboration between regulatory agencies Title and presenter awaiting confirmation 10:45-11:00 Morning Coffee Tea Data Integrity MHRA GxP Data Integrity Guideline and presenter awaiting confirmation 11:00-12:15 Data Governance from an industry perspective Robert Fjæstad Gustafsson, AstraZeneca AB 12.15-13.30 Lunch STREAM: GCP/PV STREAM: GLP STREAM: GMP/GDP/Device OECD Advisory no. 19 on the The New Annex 1 - When, What Trends in Management, and Why? inspection Characterization and Use of Matts Ramstorp, BioTekPro deviations Test Items Thorsten Frank Jørgensen, Stand-alone GMP for ATMP an 13.30-15.00 Sophie Svensson, SWEDAC – Leo Pharma overview Registration of pesticides Anna Lundén, Key2Compliance AB TBD Jesper Yngvesson, Agrolab Title and presenter to be defined 15.00-15.30 Coffee/Tea/Refreshments 15.30-17.20 Risk-based approach - practical aspects Efficient QC procedures how? – Charlotte Høgsted, Key2Q Audit trail review what trails to select for review? – Mogens Høgsbro Østergaard, Novo Nordisk 17.20-17.30 Closing remarks Post Conference Networking Event finger food, beer, wine and non-alcoholic drinks. – 17.30- An opportunity to talk and network with your colleagues at the end of the conference.
”Quality Complexity - Navigating International Challenges” The 8th Scandinavian SARQA/DKG Quality Assurance Conference DATE: November 15th, 2018 VENUE: Malmö Arena Hotel, Hyllie (Malmö) The language of this conference is English Conference fee 1400 DKK/1900 SEK 08.30-09.15 Registration/Coffee – breakfast buffet 09.15-09.30 Welcome – joint presentation SARQA and DKG 09.30-10:45 BREXIT and international collaboration between regulatory agencies UK Perspective on BREXIT Title and presenter awaiting confirmation International collaboration between regulatory agencies Title and presenter awaiting confirmation 10:45-11:00 Morning Coffee Tea 11:00-12:15 Data Integrity MHRA GxP Data Integrity Guideline and presenter awaiting confirmation Data Governance from an industry perspective Robert Fjæstad Gustafsson, AstraZeneca AB 12.15-13.30 Lunch 13.30-15.00 STREAM: GCP/PV Trends in inspection deviations Thorsten Frank Jørgensen, Leo Pharma TBD Title and presenter to be defined STREAM: GLP OECD Advisory no. 19 on the Management, Characterization and Use of Test Items Sophie Svensson, SWEDAC Registration of pesticides Jesper Yngvesson, Agrolab STREAM: GMP/GDP/Device The New Annex 1 - When, What and Why? Matts Ramstorp, BioTekPro Stand-alone GMP for ATMP – an overview Anna Lundén, Key2Compliance AB 15.00-15.30 Coffee/Tea/Refreshments 15.30-17.20 Risk-based approach - practical aspects Efficient QC procedures – how? Charlotte Høgsted, Key2Q Audit trail review – what trails to select for review? Mogens Høgsbro Østergaard, Novo Nordisk 17.20-17.30 Closing remarks 17.30- Post Conference Networking Event – finger food, beer, wine and non-alcoholic drinks. An opportunity to talk and network with your colleagues at the end of the conference.
The-8th-DKGSARQA%20prelim%20agenda.docx