Quality - Keeping up to Date? the 7Th Scandinavian SARQA/DKG Quality Assurance Conference

Quality - keeping up to date? The 7th Scandinavian SARQA/DKG Quality Assurance Conference

DATE: November 9th, 2016 VENUE: DGI BYEN Tietgensgade 65, 1704 Copenhagen

COST: EARLYBIRD until Sept 1st Members 1500 DKK /1800 SEK Non-Members 2000 DKK / 2400 SEK

From Sept 1st Members 2000 DKK /2400 SEK Non-Members 2500 DKK / 3000 SEK

(Annual Membership fee: DKG = 400 DKK + SARQA = 400 SEK)

The language of this conference is English

08.30–09.15 / Registration/Coffee – breakfast buffet
09.15–09.30 / Welcome
09.30 - 10:45 / General interest session 1:
1. Data Integrity across GxPs Anna Lundén, Key2Compliance AB
2. Computerised System Auditing for non IT-auditors Jesper Rosendal, H. Lundbeck A/S
10:45 - 11:00 / Morning Break Coffee Tea
11:00 - 12:15 / General interest session 2:
1.Quality Risk Management in GxP Outsourcing Jane Saxbol Novo Nordisk A/S
2. Quality Metrics – Measuring Quality Globally Anne Sofie Østerdal, Novo Nordisk A/S
12.15 - 13.15 / Lunch in DGI’s restaurant
13.15 - 14.45 / STREAM: GCP/GVP/GLP
1. Current Challenges in Pharmacovigilance
Betina Østergaard Eriksen, Novo Nordisk A/S
2. Impact of the ICH E6 Good Clinical
Practice Update Anders Hellgren, Hellgren GCP Consulting / STREAM: GMP/GDP/Device
1. Root Cause Analysis - CAPA Effectiveness Camilla L. Castle, Pharmakon A/S
2. GMP/GDP Inspection Trends
Bengt Berglund Medical Products Agency/ Läkemedelsverket
14.45 - 15.15 / Coffee/Tea/Refreshments
15.15 - 16.45 / STREAM: GCP/GVP/GLP
1. Strategic monitoring of non-clinical studies performed at Contract Research Organisations
Bjørg Sandberg, H. Lundbeck A/S
2. OECD’s Advisory Doc No. 17 Application of GLP Principles to Computerised Systems – interpretation considerations
Epista Life Science / STREAM: GMP/GDP/Device
1. Serialisation what’s cooking?
Christian Stage, Stage One Computing A/S
2. ISO 13485:2016–what’s new?
Anette Sjögren, Preventia AB
3. Unique Device Identifier Implementation Challenges
Petter Sahlin TechniaTranscat AB
16.50 - 17.00 / Closing remarks
17.00 - 19.00 / 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

For registration, please use this form. Payment in DKK to DKG and in SEK to SARQA: