Programme

16:00
16:00 -

Registration

Registration will begin on Sunday, 6 October, 2019 at 16h00 and end by 09h00 on Monday, 7 October, 2019.
17:00
17:00 -

Steering Group Meeting

Steering Group Meeting
19:00
19:00 -

Cocktail Reception

A welcome cocktail reception sponsored by SANAS will be hosted at Lagoon Beach Hotel on 6 October 2019 from 19h00
08:00
08:00 - 09:00 AM

Registration

Registration will begin on Sunday, 6 October, 2019 at 16h00 and end by 09h00 on Monday, 7 October, 2019.
09:00
09:00 - 09:30 AM

Welcome and Opening Remarks

RSA, OECD Secretariat & WG Chair
09:30
09:30 - 10:00 AM

GLP in International Context

Richard Sigman (OECD Secretariat)
10:00
10:00 - 10:30 AM

Overview of OECD GLP documents

Shadrack Phophi (RSA)
10:30
10:30 - 11:00 AM

Tea/Coffee Break

11:00
11:00 - 11:30 AM

Introduction to inspection process

Martin Reed (UK)
11:30
11:30 - 12:00 PM

How to select studies for a study audit

Elizabeth Moane (Australia)
12:00
12:00 - 12:30 PM

Auditing a GLP Study (including multi-studies)

Christoph Moor (Switzerland)
12:30
12:30 - 13:10 PM

Data Integrity (including electronic data)

Charles Bonapace (US - FDA)
13:10
13:10 - 14:00 PM

Lunch Break

14:00
14:00 - 15:00 PM

Workshop I

Facilitators: Marek, Charles, Christoph, Lize, Celine, Martin - How to select studies for a study audit
- Auditing a GLP study /Data integrity
15:00
15:00 -

Tea/Coffee Break

15:30
15:30 - 16:30 PM

Workshop I

- How to select studies for a study audit
- Auditing a GLP study /Data integrity
16:30
16:30 -

Discussion on Workshop I

17:30
17:30 -

Q & A Session

08:30
08:30 - 09:00 AM

Inspection of Test and Reference Items

Fariza Wan Abdullah (Malaysia)
09:00
09:00 - 09:30 AM

How to understand new requirements in document No 19

Kenji Nakano (Japan)
09:30
09:30 - 10:10 AM

Non-compliance process: Making noncompliance decision and typical examples of noncompliance decisions

Guido Jacobs (Belgium)
10:10
10:10 - 10:40 AM

Tea/Coffee Break

10:40
10:40 -

Workshop II

- Test and refence items
- Non-compliance decision
13:10
13:10 -

Lunch

13:30
13:30 -

Sightseeing

19:00
19:00 -

Welcoming Dinner

08:30
08:30 - 09:30 AM

Discussion on Workshop II

Feedback presentation by Groups
09:30
09:30 - 10:00 AM

IT systems in the test facility

Lene Bjerring Bork (Denmark)
10:00
10:00 - 10:30 AM

Inspecting the computerized system

Martjin Baeten (Belgium)
10:30
10:30 - 11:00 AM

Tea/Coffee

11:00
11:00 - 11:50 AM

IT validation & Electronic archiving

Ronald Bauer (Austria)
11:50
11:50 - 12:20 PM

Commercial/outsourced archiving

Paula Korhola (Finland)
12:30
12:30 -

Lunch

13:30
13:30 -

Workshop III – Computerised system

Facilitators: Lene, Martjin, Ronald, Paula, Christoph
16:00
16:00 -

Tea/Coffee Break

16:30
16:30 -

Discussion on workshop III

17:30
17:30 -

Q & A Session

08:30
08:30 - 09:30 AM

The Receiving Authorities

R Jaspers (The Netherlands)
- role and responsibilities
- cooperation with Receiving Authorities
09:30
09:30 - 10:00 AM

Claiming compliance with principles of GLP

Celine Dugué (France)
10:00
10:00 - 10:30 AM

Tea/Coffee Break

10:30
10:30 - 11:00 AM

Risk-based quality assurance programme

Martin Reed (UK)
11:00
11:00 - 12:00 PM

Q & A Session

12:00
12:00 - 13:00 PM

Course Evaluation /Closing remarks/Certificate Handover

Shadrack Phophi (SA) Richard Sigma (OECD)
13:00
13:00 -

End of Training

13:00
13:00 -

Lunch

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