Agenda

Africa Pharmacovigilance Meeting 2012 Agenda
Intercontinental Hotel, Nairobi, Kenya
Conference Center: Mara North

Wednesday April 18, 2012
Day 1. Dissemination Conference
Co-Chair: Mary Wangai
Chair: Fred M. Siyoi

Opening Ceremony: Welcome and Introduction
Time: 9-10:15am
Opening Remarks and Presentation – Beverly Corey, USFDA
Opening Remarks – Anthony Boni, USAID

Program Overview and Objectives
Time: 10:45-11am
Presenter(s): Mary Wangai, HCSM Kenya

Presentations of Findings from SSA Study
Time: 11-11:30am
Presenter(s): Jude Nwokike, Hye Lynn Choi, SIAPS

African Medicines Regulatory Harmonization
Time: 11:30-11:50am
Presenter(s): Margareth Ndomondo-Sigonda, NEPAD AMRH

The WHO PV Toolkit 
Time: 11:50am-12:10pm
Presenter(s): Alex Dodoo, WHO CC/Accra

PV Metrics
Time: 12:10-12:30pm
Presenter(s): Andy Stergachis, UW

The Way Forward: Global Perspective
Time: 1:30-3pm
Presenter(s): WHO Pharmacovigilance Update: Sub-Saharan Africa – Shanthi Pal, WHO
Strengthening Pharmacovigilance Systems: Lessons Learned from Europe – Xavier Kurz, EMA
Strengthening Regulatory Systems and Capcity – Thomas Bollyky, BMGF
Monitoring Safety of Antimalarial Medicines – Stephan Duparc, MMV
Implementing Risk Management Plans in Africa: The ASAQ Winthrop® Risk Management Plan – Francois Bompart,  Malaria Access to Medicines Partnership

Achieving Regional Excellence
Time: 3:30-4:30pm
Presenter(s):
Case Study from Kenya – Jayesh Pandit, Kenya
Case Study from Democratic Republic of the Congo – Tona Lutete, DRC
Case Study from South Africa – Mukesh Dheda, South Africa
Case Study from Nigeria – Adeline Osakwe, Nigeria

Panel Discussion: Access and Safety
Time: 4:30-5:55pm
Presenter(s): Chair: Margareth Ndomondo-Sigonda, NEPAD Ageny; NRA:Paul Orhii, NAFDAC; Shanthi Pal, WHO; Alex Dodoo, WHO CC/Accra; Anthony Boni, USAID; Stephen Duparc, PDP: MMV; K.C. KoskeiPPB/Kenya

Closing Remarks
Time: 5:55-6pm
Presenter(s): Sameh Saleeb, SIAPS

Thursday April 19, 2012
Day 2. Tools Workshop
Chair: David Lee

Introduction and Workshop Welcome
Time:
8:30-8:45am
Presenter(s): David Lee, SIAPS

FDA Drug Safety Practices and Tools
Time: 8:45-9:10am
Presenter(s): Gerald Dal Pan, FDA/CDER

Global Trends in PV Tools and Practices
Time: 9:10-9:35am
Presenter(s): Jude Nwokike, SIAPS

Country Presentations: National Regulatory Authorities
Time: 9:35-10:20am
Ghana – Adela Gwira, Ghana
Uganda – Helen Byomire Ndagije, Uganda
Burkina Faso – Kiema Bérenger, Burkina Faso

EMA and ENCePP Drug Safety
Time: 10:40-11am
Presenter(s): Xavier Kurz, EMA

Country Presentations: National Regulatory Authorities
Time: 11-11:30am
Senegal – Birame Dramé, Senegal
Tanzania – Alex Fabian Nkayamba, Tanzania

Country Presentations: Public Health Programs
Time: 11:30am-12:20pm
Presenter(s):
HIV/AIDS: Namibia – Johannes Gaeseb, Namibia
HIV/AIDS & TB: South Africa – Simangele Hlongwana, South Africa
Malaria: Tanzania – Rosemary Silaa, Tanzania

mHealth for Product Quality Monitoring
Time: 1:30-1:45pm
Presenter(s): Paul Orhil, NAFDAC

Surveillance of Pharmaceutical Product Quality and Safety
Time: 1:45-2:15pm
Presenter(s): Abdelkrim Smine, USP PQM

Tools for Measuring Impact
Time: 2:15-2:30
Presenter(s): Joseph B. Babigumira, UW

Operationalizing the Systems Perspective (Breakout session)
Time: 2:30-4pm

Break-out Groups: Report back
Time: 4:30-5:45pm
Moderator: UW (Andy Stergachis)
Group 1. Policy, Law and Regulation – Notes
Group 2. Systems, Structure, Stakeholder Coordination – Notes
Group 4. Risk Assessment and Evaluation Notes – Notes and Presentation
Group 5. Risk Management and Communication – Notes and Presentation

Wrap up
Time: 5:45-6pm
Presenter(s): Andy Stergachis, UW

Friday April 30, 2012
Day 3. Tools Workshop and Vaccine Safety Methods Workshop
Chair: Andy Stergachis

Welcome
Time: 8:30-8:40am
Presenter(s): David Lee, SIAPS

Summary of Priority Tools
Time: 8:40-9am
Presenter(s): Andy Stergachis, UW

Plans for Priority Tools Development
Time: 9-9:30am
Presenter(s): Jude Nwokike, SIAPS

Active Surveillance in Africa
Time: 9:30-9:45am
Presenter(s): Peter Bassi, NAFDAC Drug Safety Advisory Committee

Active Surveillance for Safety Monitoring
Time: 9:45-10:15am
Presenter(s): Jude Nwokike, Hye Lynn Choi, SIAPS

The Global Vaccine Safety Initiative
Time: 10:30-10:50am
Presenter(s): Patrick Zuber, WHO

Presentation of the Workshop Objectives and Format
Time: 10:50-11am
Presenter(s): Hector Izurieta, FDA/CBER

Vaccine Safety and Adverse Events Following Immunization
TIme: 11am-12:30pm
Presenter(s): Hector Izurieta, FDA/CBER

Vaccine Active Surveillance I
Time: 1:30-2:30pm
Presenter(s): Caitlin Dodd, Cincinnati Children’s Hospital

Vaccine Active Surveillance II
Time: 2:30-3:30pm
Presenter(s): Hector Izurieta, FDA/CBER

Potential for the INDEPTH Network to Contribute to International Collaborative Epidemiological Studies of Vaccine Safety
Time: 3:45-4pm
Presenter(s): Kayla Laserson and Stephanie Dellicour, KEMRI/CDC

Exercises and Discussions
Time: 4-5:15pm
Presenter(s): Hector Izurieta, FDA/CBER; Caitlin Dodd, Cincinnati Children’s Hospital; Kayla Laserson, KEMRI/CDC

Exercises and Discussions
Time: 5:15-5:30
Presenter(s): David Lee, SIAPS

Closing Remarks
Time: 5:30-5:45pm
Presenter(s): Anthony Boni, USAID

Closing Ceremony
Time: 5:45-6pm
Presenter(s): Fred Siyoi, Local Organizing Committee; Sameh Saleeb, SIAPS