ISOP 2021 SATELLITE TRAINING COURSES
| Pre – conference course I – Nov 01 | Pre – conference course II – Nov 02 & 04 | Post – 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 Authorities | Making and Assessing Periodical Benefit-Risk Evaluation Reports (PSUR – PBRERs) |
| Responsible: Saad Shakir | Responsibles: Eugene van Puijenbroek and Mulugeta Russom | Responsible: 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 I | GMT | Oman |
|---|---|---|
| November 01 | UTC | UTC+4 |
| Session A start | 08:00 | 12:00 |
| Session A end | 09:30 | 13:30 |
| 30' | ||
| Session B start | 10:00 | 14:00 |
| Session B end | 11:30 | 15:30 |
| 30' | ||
| Session C start | 12:00 | 16:00 |
| Session C end | 13:30 | 17:30 |
| 30' | ||
| Session D start | 14:00 | 18:00 |
| Session D end | 15:30 | 19:30 |
| Training II | GMT | Oman |
|---|---|---|
| November 02 | UTC | UTC+4 |
| Session A start | 08:00 | 12:00 |
| Session A end | 09:30 | 13:30 |
| 30' | ||
| Session B start | 10:00 | 14:00 |
| Session B end | 11:30 | 15:30 |
| November 04 30' | ||
| Session C start | 12:00 | 16:00 |
| Session C end | 13:30 | 17:30 |
| 30' | ||
| Session D start | 14:00 | 18:00 |
| Session D end | 15:30 | 19:30 |
| Training III | GMT | Oman |
|---|---|---|
| November 18 | UTC | UTC+4 |
| Session A start | 06:30 | 10:30 |
| Session A end | 08:30 | 12:30 |
| 30' | ||
| Session B start | 09:00 | 13:00 |
| Session B end | 10:30 | 14:30 |
| 30' | ||
| Session C start | 11:00 | 15:00 |
| Session C end | 13:00 | 17:00 |
ISoP 2021 – PRELIMINARY PROGRAMME
Monday 8 November
|
Session
|
Timing |
Time UTC-GMT |
Session title |
|
|
1A |
20′ |
07.00– 07.20 |
Opening ceremony |
|
|
1A |
70′ |
07.20 -08.30 |
Session: |
|
|
30′ |
08.30 – 9.00 |
Break and poster viewing |
||
|
1B |
90′ |
09.00-10.30 |
Session on Covid-19 vaccine safety surveillance (Part II) |
|
|
30′ |
10.30 – 11.00 |
Break and poster viewing |
||
|
1C |
90′ |
11.00 – 12.30 |
Session: Coordinating key stakeholders of national pharmacovigilance systems |
|
|
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) |
|
|
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) |
|
|
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
|
|
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? |
|
|
|
|
08.30-09.00 |
Break and poster viewing |
|
|
2B |
90′ |
09.00-10.30 |
Session: Incorporating new patient safety challenges into pharmacovigilance |
|
|
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 |
|
|
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 |
|
|
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 |
|
|
30′ |
16.30 – 17.00 |
Break and poster viewing |
||
|
2F |
30′ |
17.00-18.30 |
Session: Global pharmacovigilance: Hot topics from the ISoP regions |
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 |
|
|
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 |
|
|
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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