Programme

Tuesday, 20th February 2018

08:15 Registration and Welcome Coffee
09:00 Welcome
Ingrid Klingmann, Pharmaplex, EFGCP, Belgium
PLENARY SESSION 1
SETTING THE SCENE
Chairpersons: Paul Strickland, Strickland Quality Assurance, UK
Dimitrios Athanasiou, United Parent Projects Muscular Dystrophy (UPPMD)  & MDA HELLAS, EFGCP, Greece
09:05 Key Note Presentation:  Current level of compliance that inspectors find, expected trends and developments
Lisbeth Bregnhoj, DKMA, Denmark
09:25 Pros and cons, needs and challenges of complex protocols
Denis Lacombe, EORTC, Belgium
09:45 Leadership, team work and communication: systematic impact on the human factor
Andy Parsons, Reciprocal Minds Limited,  UK & Allison Morgan, Metis Clinical, UK
10:05 Questions & Discussion
11:00 Coffee Break
PLENARY SESSION 2
HOW CAN OUR CURRENT QUALITY FRAMEWORK HELP US TO MANAGE COMPLEXITY, COMPLIANCE AND COLLABORATION MORE EFFICIENTLY?
Chairperson: Susan Trainor, Trainor & Partners Clinical QA, Belgium
Speaker Invited
11:30 Will ICH-E6(R2) be help or hinderance for improving clinical medicine development?  
Florian von Raison, Novartis, Switzerland
11:55 Is today’s ISO framework efficiently driving medical device trials performance?
Myra Daridan, CC Clinical Research Consultants, France
12:20 Panel and Open Forum Discussion
13:00 Lunch
BREAK-OUT SESSION – WORKSHOPS 1-2-3
14:00 Workshop 1:
Welcome to the ‘Research Ethics by Design Initiative ‘: Pulling together to build Multi-National Capacity and Credibility
Chair: Heather Sampson, University of Toronto, Canada
Rapporteur: Andrea Heckenberg, Medical University Vienna, Austria
Workshop 2:
Vendor Oversight – Overseen or Overlooked
Chair: Nicky Dodsworth, Premier Research, UK
Rapporteur: Paul Strickland, Strickland Quality Assurance, UK
Workshop 3:
The role of engaged patients in process improvements/protocol design
Chair: Tamás Bereczky, European AIDS Treatment Group, Germany
Rapporteur: Tanja Keiper, Merck Group, Germany
15:30 Coffee Break
16:00 Feedback from Workshops 1-2-3
Chair: Heather Sampson, University of Toronto, Canada
PLENARY SESSION 3
THE JOSEPH HOET LECTURE ON ETHICS IN CLINICAL RESEARCH
Chairperson: Ingrid Klingmann, Pharmaplex, EFGCP, Belgium
16:30 GCP – literally or common sense? – A personal reflection
Gunnar Danielsson, DGD Consulting, Former GCP Inspector MPA, Sweden
17:00 EFGCP Annual General Meeting (for EFGCP Members)
18:30 EFGCP Annual Conference Social Event
(Accessible to all who purchased a ticket in advance)

 

Wednesday, 21st February 2018

08:30 Welcome Coffee
PLENARY SESSION 4
HUMAN FACTOR – THE DRIVING FORCE FOR GOOD AND BAD?
Chairperson: Eric Klasen, Medtronic, Switzerland
09:00 Take the Human Factor into account!
Ewelina Korczowska, European Society of Oncology Pharmacy (ESOP), Poland
09:20 Questions & Discussion
09:30 Adapting processes to allow humans to perform effectively
Panellists: Brian Edwards, Chair, UK Pharmaceutical Ergonomics & Human factors Group; Lynne Van Poelgeest, World Federation for Incontinent Patients (WFIP), The Netherlands; Gunnar Danielsson, DGD Consulting, Former GCP Inspector MPA, Sweden , Tanja Keiper, Merck Group, Germany
10:25 Summary 
Eric Klasen, Medtronic, Switzerland
10:30 Coffee Break
BREAK-OUT SESSION – WORKSHOPS 4-5-6
11:00 Workshop 4:
International review group: when things go wrong
Chair: Brian Edwards, Chair, UK Pharmaceutical Ergonomics & Human Factors Group, UK
Rapporteur: Kerstin Breithaupt-Grögler, KBR, EUFEMED, Germany
Workshop 5:
New responsibilities of PIs as defined in ICH-GCP(R2)
Chair: Bruno Francois, CHU Limoges, France
Rapporteur: Ingrid Klingmann, Pharmaplex, EFGCP, Belgium
Workshop 6:
Revised CIOMS ethics guidelines: How they could help to manage compliance, complexity and collaboration
Chair: David Haerry, EATG, Switzerland
Rapporteur: Rieke van der Graaf, University Centre Utrecht, The Netherlands
12:30 Lunch
13:30 Feedback from Workshops 4-5-6
Chair: Geneviève Depresseux, Captitude, Belgium
PLENARY SESSION 5
PROPOSALS FOR SOLUTIONS
Chairperson: Speaker Invited
14:00 New initiatives for system redesign to better manage compliance, complexity and collaboration
Ysbrand Poortman, EGAN, The Netherlands
14:20 New initiatives for system redesign to better manage compliance, complexity and collaboration
Beat Widler, Widler & Schiemann AG, Switzerland
14:40 Optimising collaboration to maximise compliance
Barney Horne, Daiichi Sankyo UK, representing RQA, UK
15:00 Compliance, complexity and collaboration – the inspector’s view
Gail Francis, National Institute for Biological Standards and Control – A Centre of the Medicines and Healthcare Products Regulatory Agency, UK
15:20 Questions & Open Forum Discussion
15:45 Summary & Conclusions from the Conference
Eric Klasen, Medtronic, Switzerland
Speaker Invited
16:00 End of the Conference