21 September 2017 EMA/195334/2017 Committees and Inspections

Programme for the 2017 EU GCP IWG Workshop 03-05 October 2017 in Budapest (Hungary)

Chair:

Laura Pioppo (EMA)

Co-Chair:

Dora Hermann (HU-OGYEI)

Day 1 – Tuesday, 03 October 09:00-17:45 Time

Topic

Speaker

09:00-09:30

Welcome and introduction with training purpose and

Csilla Pozsgay

objectives

(HU-General Director)

1. Sponsor site inspections 9:30-10:40

•

Centralised monitoring

•

Computer system validation: −

How to apply the theoretical knowledge in practice

− −

Willem Verweij (NL-IGZ) Balall Naeem (UK-MHRA)

Different strategies on computer system

Ib Alstrup

validation

(DK-DKMA)

Typical deviations identified during inspections

10:40-11:00

Q&A

11:00-11:30

Coffee Break

11:30-13:00

BREAK OUT Session A–Discussions on case studies on

Panel:

centralised monitoring and inspections of computer

Willem Verweij

system validation

(NL- IGZ)

Groups:

Balall Naeem

Room Hungaria: groups 1 - 4

All

(UK-MHRA)

Room Continental: groups 5 - 6

Ib Alstrup

Room Buda: groups 7 - 8

(DK-DKMA)

Room Pest: groups 9

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 8400 Facsimile +44 (0)20 3660 5535 E-mail [email protected] Website www.ema.europa.eu

An agency of the European Union

© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

Time

Topic

13:00-14:00

Lunch Break

14:00-15:00

Feedback session

Speaker

All

2. Difficulties when performing un-announced GCP inspections 15:00-15:40

15:40-16:00

•

Difficulties when performing un-announced GCP

Dorota Kurnik

inspections

(PL-URPL)

Coffee Break

3. GCP international collaboration 16:00-17:00

•

•

•

GCP inspection in Thailand and ASEAN cooperation

Rachada To-a-nan

on Bioequivalence study

(Thailand-FDA)

Practical experiences in GCP inspections in Republic

Lina Gudima

of Moldova

(Republic of Moldova-AMED)

Regulatory framework for Malaysian GCP inspection,

Yam Pei Ching

inspection findings and future collaboration

(Malaysia-NPRA)

17:00-17:30

Q&A

All

17:30-17:45

Conclusions and feedback on Day 1

All

Day 2 – Wednesday, 04 October 09:00-17:00 Time

Topic

09:00-09:05

Introduction to day 2

Speaker

4. Patient Reported Outcome (PRO)/e-PRO: what to consider during a GCP inspection 09:05-09:45

•

PRO/e-PRO: what to consider during a GCP

Lisbeth Bregnhoj

inspection

(DK-DKMA)

5. GCP inspections of phase I units 09:45-10:30

•

•

GCP inspections of phase I units - the Italian

Angela Del Vecchio

perspective

(IT-AIFA)

GCP inspections of phase I units - the Hungarian

Dora Hermann

perspective

(HU-OGYEI)

10:30-11:00

Q&A

11:00-11:30

Coffee break

Programme for the 2017 EU GCP IWG Workshop EMA/195334/2017

All

Page 2/4

Time

Topic

Speaker

11:30-13:00

BREAK OUT Session B–Discussions on case studies on

Panel:

inspections of PRO/e-PRO

Lisbeth Bregnhoj

Groups: Room Hungaria: groups 1 - 4 Room Continental: groups 5 - 6

(DK-DKMA) Dora Hermann (HU-OGYEI)

Room Buda: groups 7 - 8

Fabrizio Galliccia

Room Pest: groups 9

(IT-AIFA)

13:00-14:00

Lunch break

14:00-15:00

Poster Session 1

All

6. Updates on the Clinical Trials Regulation no. 536/2014 15:00-15:40

15:40-16:00

•

Overview of the procedure for authorising clinical

Laura Pioppo

trials

(EMA)

•

EU Portal and Database: developments

•

Overview of the Implementing Act and transition

Maja Leon Grzymkowska

period

(COM) - via TC

16:00-16:20

Coffee break

16:20-16:50

Q&A session

16:50-17:00

Conclusions and feedback on day 2

18:00-22:30

Social event

All

Day 3 – Thursday, 05 October 09:00-13:00 Time

Topic

09:00-09:05

Introduction to day 3

Speaker

7. GCP inspections of biosimilars - assessors’ perspectives 09:05-9:45

•

Biosimilars – complex structures, comparable drugs

•

Biosimilars – Assessor’s perspective: Clinical key points

Krisztian Fodor (HU-OGYEI, CAT member) Francesca Serone (IT-AIFA, CHMP assessor) - via TC

9:45-10:05

Q&A session

All

8. Inspections of oncology trials 10:05–10:45

•

Oncology trials–points to consider for inspection

Sinead Curran & Marie

including patient safety aspects and including efficacy

Callaghan

aspects (use of RECIST and common issues),

(IE-HPRA)

Programme for the 2017 EU GCP IWG Workshop EMA/195334/2017

Page 3/4

Time

Topic

10:45-11:15

Coffee Break

11:15-11:45

Oncology trials-2 case studies

11:45-12:00

Q&A session

Speaker

Sinead Curran & Marie

12:00-13:00

Callaghan (IE-HPRA) All

Conclusions of workshop and distribution of certificates

Programme for the 2017 EU GCP IWG Workshop EMA/195334/2017

Page 4/4

Programme 2017 EU GCP Inspectors Working Group Workshop

Sep 21, 2017 - EU Portal and Database: developments. Laura Pioppo. (EMA) ... Biosimilars – Assessor's perspective: Clinical key points. Krisztian Fodor.
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