Slides – EBF Autumn Focus Workshop 2022 – 1
Managing GCP in Regulated Bioanalysis –
Considerations for Best Practices from the EBF
15-16 september 2022 – NH Malaga, Spain
PDF renditions of the powerpoint presentations given at the Focus Workshop can be viewed and downloaded from this page.
The agenda as executed can be viewed and downloaded by clicking here
Overview of EBF GCP Team discussions on GCP challenges
| Day 1: 15 september 2022 | |||||
| 9:45 | 10:00 | Welcome and aim of the meeting | |||
| 10:00 | 11:00 | Session 1: Setting the scene | |||
| 10:00 | 10:20 | Philip Timmerman, EBF | |||
| Introduction to the meeting | |||||
| 10:20 | 10:40 | Tsvetelina Ivanova, on behalf of the EBF | |||
| Overview of EBF GCP Team discussions on GCP challenges | |||||
| 10:40 | 11:00 | Philip Timmerman, on behalf of the EBF | |||
| GCP for Bioanalysis – Can we learn from GLP? | |||||
| 11:00 | 11:30 | Coffee break | |||
| 11:30 | 12:30 | Session 2: Looking at the different angles | |||
| 11:30 | 11:45 | Stuart McDougall, on behalf of the EBF | |||
| GCP and MHRA – setting the bar | |||||
| 14:45 | 12:00 | Matthew Barfield, F. Hoffmann – La Roche | |||
| GCP from and EMA/Swiss Medic perspective | |||||
| 12:00 | 12:15 | Lee Monk, UCB Biopharma | |||
| GCP from a lab QA perspective | |||||
| 12:15 | 12:30 | Magnus Knutsson, Bayer (not released for publication) | |||
| GCP challenges from a Pharma/CRO project management interface perspective | |||||
| 12:30 | 13:30 | Lunch Break | |||
| 13:30 | 15:30 | Session 3: Communication | |||
| During this big session we plan to go over the challenges related all aspects of study communication, incl. Issue communication / withdrawal/IC issues. | |||||
| 13:30 | 14:00 | Jo Goodman/Michaela Golob, on behalf the EBF | |||
| FB from EBF GCP team discussions on communication with focus on stakeholder communication around study protocols, informed consent, sample disposition, study documentation & archiving/retention | |||||
| 14:00 | 14:20 | Tessa McDonald, Intertek | |||
| Clinical Sample Handling – a CRO’s challenge | |||||
| 14:20 | 14:40 | Sophia Christou, Drug Development Services Alliance Pharma | |||
| Importance of Informed Consent Process and how it relates to Regulated Bioanalysis | |||||
| 14:40 | 15:00 | Adriaan Tigchelaar, Janssen R&D | |||
| Effective communication in a bioanalytical lab environment | |||||
| 15:00 | 15:30 | Introduction to round tables discussion 1 | |||
| Round table 1: GCP communication requirements (pre, during, post study) in practice: challenges, responsibilities and accountabilities (with focus on IC)Round table 2: What do GCP guideline/reflection papers requirements mean for BMV for the lab?Round table 3: Communication around sample disposition, study documentation & archiving/retention | |||||
| 15:30 | 16:10 | Coffee Break | |||
| 16:10 | 17:20 | Round table Session 1 | |||
| Delegates split into round tables on above items. Moderators rotate to tables and consolidate discussions | |||||
| Survey with pre-meeting questions can be part of the round table discussions | |||||
| 17:20 | 17:30 | Short logistic break | |||
| 17:30 | 19:00 | Session 5: Learnings from inspections shaping our minds | |||
| In this session we discuss experiences from inspections/risk of confusing GCP and GLP requirements | |||||
| 17:30 | 17:50 | Tsvetelina Ivanova, on behalf of the EBF | |||
| FB from EBF GCP team discussions on learning from inspections | |||||
| 17:50 | 18:10 | Stuart McDougall, Quotient Sciences | |||
| FB from EBF GCP team discussions on learning from inspections | |||||
| 18:10 | 19:00 | “SERT” – Sharing Experience Round Table | |||
| Delegates will be invited to share experience (round table). “Cases” will be gathered from a pre-meeting survey to all registered delegates. Moderators rotate to tables and consolidate discussions. | |||||
| 19:00 | Day 1 close out | ||||
| Day 2: 16 september 2022 | |||||
| 8:30 | 10:20 | Session 6: Diving in deeper on Equipment maintenance and validation, role of QA and training | |||
| During this session we plan to discuss the challenges of over interpretation related to CSV, equipment validation and maintenance, incl. SOP management | |||||
| 8:30 | 8:35 | Philip Timmerman, on behalf of the EBF | |||
| Introduction to day 2 | |||||
| 8:35 | 9:00 | Cecilia Arfvidsson, on behalf of the EBF | |||
| FB from EBF GCP team discussions on Equipment maintenance and validation – inlcudes GCP relevant info from EBF e-data and Data integrity team | |||||
| 9:00 | 9:25 | Floris Bové, on behalf of the EBF | |||
| FB from EBF GCP team discussions on the role of QA | |||||
| 9:25 | 9:45 | Lee Monk, UCB Biopharma | |||
| Experiences – risk based audits… | |||||
| 9:45 | 10:10 | Tsvetelina Ivanova, on behalf of the EBF | |||
| FB from EBF GCP team discussions on GCP training for the BA lab | |||||
| 10:10 | 10:20 | Introduction to round tables discussion day 2 | |||
| Round table 4: Role of QA/risk based auditsRound table 5: Equipment maintenance/validation and CSVRound table 6: How to approach GCP training for BA? | |||||
| 10:20 | 11:00 | Coffee break | |||
| 11:00 | 12:30 | Round table session 2 | |||
| Delegates split into round tables on above items. Moderators rotate to tables and consolidate discussions | |||||
| Survey with pre-meeting questions can be part of the round table discussions | |||||
| 12:30 | 13:30 | Lunch | |||
| 13:30 | 15:00 | Session 7: Feedback from the round tables and building the EBF recommendation | |||
| During this close out afternoon session we will try to build ‘best practices’ recommendation covering several aspect discussed during the workshop round tables. | |||||
| Round table 1: GCP communication requirements (pre, during, post study) in practice: challenges, responsibilities and accountabilities (with focus on IC)Round table 2: What do GCP guideline/reflection papers requirements mean for BMV for the lab?Round table 3: Communication around sample disposition, study documentation & archiving/retentionRound table 4: Role of QA/risk based audits
Round table 5: Equipment maintenance/validation and CSV Round table 6: How to approach GCP training for BA? |
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| Summary slides of the round tables will be added after the 15th Open Symposium | |||||
| 15:00 | 16:00 | Close out & networking coffee break | |||
| Organising Committee: Tsvetelina Ivanova (Comac Medical), Joanne Goodman (AstraZeneca), Stuart McDougall (Quotient Sciences), Steve White (GlaxoSmithKline), Michael Golob (Nuvisan), Lee Monk (UCB Biopharma) and Philip Timmerman (EBF) | |||||
| EBF Focus workshops are organised by the EBF vzw as non-sponsored non-profit events and are independent from EBF member companies. | |||||
