ISOP 2021 SATELLITE TRAINING COURSES 

Pre – conference course I – Nov 01Pre – conference course II – Nov 02 & 04Post – conference course III – November 18
Pharmacoepidemiological Methods in Pharmacovigilance (in collaboration with Drug Safety research unit – DSRU)Managing Safety Signals in Daily Practice – A Challenge for License Holders and Health AuthoritiesMaking and Assessing Periodical Benefit-Risk Evaluation Reports (PSUR – PBRERs)
Responsible: Saad ShakirResponsibles: Eugene van Puijenbroek and Mulugeta RussomResponsible: Jean-Christophe Delumeau
Course I - Outline
The training will provide an overview of the methods and approaches used in pharmacoepidemiological analysis of big observational datasets. Strengths and weaknesses of such analytical approaches will be explained, and the main sources of data presented. Benefits of combining such population-based analyses with patient focused and clinical analyses used in pharmacovigilance will be discussed.

This course will be organised online on November 01 according to 4 sessions, including lectures, Q&As, and panel discussions.

Sign-up now!

MORE INFORMATION AND PROGRAMME AVAILABLE HERE
Course II - Outline
Pharmacovigilance activities generate new signals of possible drug related problems from many different sources and of varying quality and strength. This course will discuss how to validate and confirm safety signals and how to decide what actions to take and when. Representatives from regulators and industry will give perspectives of their respective roles and responsibilities in informing healthcare professionals and patients about new safety information.

This course will be conducted online on November 2 and 4. Each of those two days will be composed of 2 sessions of 120 minutes each, including lectures and practicum, separated by 30-minute intermissions for relaxing.


Sign-up now!

MORE INFORMATION AND PROGRAMME AVAILABLE HERE
Course III - Outline
In the context of global regulatory strengthening, an increasing number of National Regulatory Authorities (NRAs) request receiving Periodic Benefit-Risk Evaluation Reports (PBRERs). This results in a substantial additional burden for both NRAs and License Holders requested to generate additional documents according to country-specific timelines. This course will be addressing the challenges faced for scheduling, making, and assessing PBRERs in a global context no longer limited to Health Authorities members of the ICH organisation.

This course will be organised online on November 18 according to 3 sessions, including lectures, Q&As, and panel discussions. The agenda will include: a) The methods and practices for Assessing Benefits versus Risks and Uncertainties, b) The PBRER concept, its making and distribution in a global context, c) and the PBRER assessment methods and practices. The event will be ending with a panel discussion on “How to transfer PBRER review know-how to National Regulatory Authorities starting to request reviewing them. How to facilitate, support, take advantage from reliance and work-sharing”.


Sign-up now!

MORE INFORMATION AND PROGRAMME AVAILABLE HERE
Training IGMTOman
November 01UTCUTC+4
Session A start 08:0012:00
Session A end09:3013:30
30'
Session B start10:00
14:00
Session B end11:3015:30
30'
Session C start12:0016:00
Session C end13:3017:30
30'
Session D start14:0018:00
Session D end15:3019:30
Training IIGMTOman
November 02UTCUTC+4
Session A start 08:0012:00
Session A end09:3013:30
30'
Session B start10:0014:00
Session B end11:3015:30
November 04
30'
Session C start12:0016:00
Session C end13:3017:30
30'
Session D start14:0018:00
Session D end15:3019:30
Training IIIGMTOman
November 18UTCUTC+4
Session A start06:3010:30
Session A end
08:3012:30
30'
Session B start09:0013:00
Session B end10:3014:30
30'
Session C start11:0015:00
Session C end13:0017:00

ISoP 2021 – PRELIMINARY PROGRAMME

Monday 8 November

 

Session

 

 

Timing

 

Time 

UTC-GMT

 

Session title

1A

20′

07.00– 07.20

Opening ceremony
Mira Harrison-Woolrych (President of ISoP), Sten Olsson (Chair of the Scientific Committee), and Mayada Alkhakany (Chair of the Local Organising Committee)

1A

70′

07.20 -08.30

Session:
Global post marketing safety surveillance of Covid-19 vaccines – planning and implementation (Part I)
Session chairpersons: Sten Olsson (ISoP) & Shanthi Pal (WHO)

30′

08.30 – 9.00

Break and poster viewing

1B

90′

09.00-10.30

Session on Covid-19 vaccine safety surveillance (Part II)
Session chairpersons: Sten Olsson (ISoP) & Shanthi Pal (WHO)

30′

10.30 – 11.00

Break and poster viewing 

1C

90′

11.00 – 12.30

Session: Coordinating key stakeholders of national pharmacovigilance systems
Session chairpersons: Manal Younus (Iraqi Pharmacovigilance Center, Ministry of Health, Iraq)
& Jean-Christophe Delumeau (Bayer, Singapore)                            

30′

12.30 -13.00

Break and poster viewing

1D

90′

13.00 – 14.30

Session: Harmonizing safety surveillance across different groups of health products (Part I)
Session chairpersons: Comfort Ogar (Management Sciences for Health, Nigeria) & Thamer Alshammary
(King Saud University, Saudi Arabia)

30′

14.30 – 15.00

Break and poster viewing

1E

90′

15.00 – 16.30

Session: Harmonizing safety surveillance across different groups of health products (Part II)
Session chairpersons: Comfort Ogar (Management Sciences for Health, Nigeria) & Thamer Alshammary (King Saud University, Saudi Arabia)

30′

16.30 -17.00

Break and poster viewing

1F

90′

17.00 -18.30

Session: Integrating safety data and knowledge from different information sources
Session chairperson: Andrew Bate (GSK, UK)

 

Tuesday 9 November

Session

Timing

Time 

UTC-GMT

Session title

2A

90′

07.00- 08.30

Session: Risks and benefits of medicines in pregnancy: how can pharmacovigilance support women and their families? 
Session chairpersons: Mira Harrison-Woolrych (President of ISoP) & Manal Younus (Iraqi Pharmacovigilance Center, Ministry of Health, Iraq)
(In collaboration with ISoP Women’s Medicines SIG)

 

 

08.30-09.00

Break and poster viewing

2B

90′

09.00-10.30

Session: Incorporating new patient safety challenges into pharmacovigilance
Session chairpersons: Thamer Alshammari (King Saud University, Saudi Arabia) & Andrea Kuemmerle (Switzerland)

30′

10.30-11.00

Break and poster viewing

2C

90′

11.00-12.30

Session: Trends in development of global regulatory frameworks for pharmacovigilance
Session chairperson: Sten Olsson (ISoP)

30′

12.30 – 13.00

Break and poster viewing

2D

30′

13.00 -14.00

ISoP General Assembly

2D

30′

14.00 -14.30

Plenary lecture – Beje Lecture
Session chairperson: Shanthi Pal (WHO)

A unified national approach for safety surveillance of all medicinal products – a case study

30′

14.30 -15.00

Break and poster viewing

2E

90′

15.00-16.30

Session: Promoting Patient Safety through Pharmacovigilance Infographics
Session chairpersons: Angela Caro (Colombian Pharmacovigilance Association, Colombia) & Priya Bahri (European Medicines Agency, Netherlands)

30′

16.30 – 17.00

Break and poster viewing

2F

30′

17.00-18.30

Session: Global pharmacovigilance: Hot topics from the ISoP regions
Session chairperson: Rebecca Chandler (Uppsala Monitoring Centre)

Wednesday 10 November

 

Session

 

 

Timing

 

Time

UTC-GMT

 

Session Title

3A

90′

07.00-08.30

Session: Combining local, regional and global perspectives in pharmacovigilance – increasing reliance
Session chairpersons: Jean-Christophe Delumeau (Bayer, Singapore), Manal Younus (Iraqi Pharmacovigilance Center, Ministry of Health, Iraq) & Comfort Ogar (Management Sciences for Health, Nigeria)

30′

08.30-09.00

Break and poster viewing 

3B

90′

09.00-10.30

Session: Integrating pharmacovigilance monitoring of vaccines into national and international public health
Session chairpersons: Rebecca Chandler (Uppsala Monitoring Centre) & Andrea Kuemmerle (Switzerland)

30′

10.30.11.00

Break and poster viewing

3C

30′

11.00-11.30

CIOMS lecture: Patient involvement in the development and safe use of medicines

3D

30′

11.30 -12.00

Keynote lecture 

15′

12.00 – 12.45

Poster prize awards

45′

12.00 – 12.45

Poster prize awards and short communication from winners

15′

12.45 – 13.00

ISoP 2022 statement and Closing remarks

ISOP 2021 Secretariat: C-IN, 5. kvetna 65, 140 21 Prague 4, CZE | tel.: +420 261 174 301
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