Fifth Symposium, ISoP Latin American Chapter

October 29-30, 2018 Universidade de São Paulo, Facultade de Saúde Pública Auditório João Yunes Av. Dr. Arnaldo, 715 São Paulo - SP - Brasil - CEP - 01246-904

Symposium Faculty Brian Edwards, UK ISoP Chapters Coordinator Elki Sollenbring, Sweden UMC, Education and Consulting Team Anthony Wong, Brazil Poison Control Centre (CEATOX) Luis Alesso, Argentina ISoP Latin American Chapter President Raquel Herrera Comoglio, Argentina ISoP Latin American Chapter Coordinator Adalton Ribeiro, Brazil Universidade de São Paulo Fernanda Simioni, Brazil ANVISA, Pharmacovigilance Head Fernando Aith, Brazil Universidade de São Paulo

http://novahygeia.fsp.usp.br/site/

Ad-hoc Speakers Ricardo García, Brazil Ieda Laurindo, Brazil Mauricio Perroud, Brazil Carlos Alberto Calderón Ospina, Colombia Elaine Rodrigues de Castro, Brazil Cristina Andrusaitis, Brazil Jeremy Jokinen, AbbVie Inc. USA Helaine Capucho, Brazil

Lectures on

• Quantity and Quality of Spontaneous Reporting • The importance of comprehensive signal detection • Risk management Plan • Pharmacovigilance of Biotherapeutic medicines • Pharmacovigilance from the patient standpoint • Value of Safety Clinical Prospective Registries • New trends in Safety surveillance

AUDITÓRIO JOÃO YUNES UNIVERSIDADE DE SAO PAULO FACULTADE DE SAÚDE PÚBLICA

5th Symposium, ISoP Latin American Chapter | AGENDA OCT 29 In collaboration with the Universidade de São Paulo

TIME SECTION TALK SPEAKER

09:00-09:15

Opening

ISoP, Latin American and USP welcome

Adalton Ribeiro

Luis Alesso

Anthony Wong

09:15-10:00 Pharmacovigilance and Public Health Fernando Aith

10:00-10:30 Pharmacovigilance: What do we need in Brazil Anthony Wong

10:30-11:00 Priorities for Pharmacovigilance in Latin America Luis Alesso

COFFEE BREAK

11:30-13:00

Strategies for increasing the

quantity and quality of

spontaneous reporting:

Best Practices

Developing a positive reporting culture Elki Sollenbring

Simulated or voluntary reporting? Adalton Ribeiro

The value of publication of case reports in PV Carlos Calderón Ospina

LUNCH

14:00-15:10

The importance of

comprehensive signal detection

Signal detection in Brazil Fernanda Simioni

How to find meaningful signals TBC

Pharmacovigilance Data Mining: A frequency-

based method Jeremy Jokinen

COFFEE BREAK

15:30-16:00

Pharmacovigilance of

Biotherapeutic medicines

Update on PV regulation in Biological Therapies Brian Edwards

16:00-16:30 Update on regulation for biotherapeutics in Latin

America: Naming and Extrapolation Ricardo Garcia

16:30-17:00 Pharmacovigilance in Biologics Adalton Ribeiro

5th Symposium, ISoP Latin American Chapter | AGENDA OCT 30 In collaboration with the Universidade de São Paulo

TIME SECTION TALK SPEAKER

09:00-10:10 Effective and Interactive

Communication in

Pharmacovigilance

Interview and Discussion Panel

Pharmacovigilance from the patient point of view

Panel Chairman:

A local journalist

PAG Leader

Fernanda Simioni

Cristina Andrusaitis

Anthony Wong

Ricardo Garcia

Luis Alesso

COFFEE BREAK

10:25-12:00 Risk Management Plan

Reasons for success and failure of RMPs:

What we have learnt? Brian Edwards

RMPs in Brazil: Our requirements Fernanda Simioni

Importance of RMPs for biotherapeutics TBC

LUNCH

13:00-14:45 Pharmacovigilance in action:

Current and new trends

Preventing Medication errors Mauricio Perroud

The impact of Pharmacovigilance training in

Universities Elaine Castro

Patient safety: Experiences and perspectives Helaine Capucho

COFFEE BREAK

15:00-15:30

Value of Clinical Prospective

Registries in Pharmacovigilance

Challenges in Prospective Safety Registries Raquel Herrera Comoglio

15:30-16:00 Teratogens: A public health issue Fernanda Vianna

16:00-16:30 Registries in Autoimmune disorders Ieda Laurindo

16:30-17:00 Closing Remarks

Luis Alesso

Anthony Wong

Adalton Ribeiro