training programme in pharmaceutical medicine
safety and risk
management
INFARMED, Lisbon
08 - 10 march 2012
safety and risk
management
08 – 10 MARch 2012
LocaL: INFARMED, Lisbon
curricuLar unit Leader: teresa Herdeiro, Pharmd, MPhil, Phd
Lecturers: Ana Araújo, Madalena Arriegas, Salvatore Curti, Germano Ferreira, Helena Gama, Teresa Herdeiro,
Sandra Madaleno, Alexandra Pêgo, Dirk Teuwen, Inês Vaz.
organisation:
Masters in Pharmaceutical Medicine
Post-Graduate course in Pharmaceutical Medicine
Director: Luis Almeida, MD, PhD, FFPM ([email protected])
Deputy Director: Bruno Gago, PharmD, PhD (bmgago@ ua.pt)
address:
Health Sciences Department
University of Aveiro
Campus Universitário de Santiago | Edifício III
3810-193 Aveiro | Portugal
Tel. +351 234 370 213 | Fax +351 234 401 597 |
E-mail: [email protected] | http://www.cs.ua.pt
DAy 01 08 MARCH
time
Programme
Lecturer
10h00-10h30
0.
introduction
Teresa Herdeiro
(University of Aveiro)
1.
History and background of Pharmacovigilance
10h30-12h00
1.1. History; 1.2. The WHO and safety reporting; 1.3. ICH and CIOMS
initiatives. CIOMS – function and purpose; 1.4. Legal basis in the EU
and the US; 1.5. New European Pharmacovigilance legislaton
Ana Araújo
(INFARMED)
12h00-13h00
1.6. Assessment and classification of adverse events (AEs),
adverse drug reactions (ADRs). Serious Adverse Events (SAEs)
and Suspected Unexpected Serious Adverse Reactions (SUSARs);
evidence for association and causality; 1.7. The concept of benefit /
risk assessment. determination of causal relationship between the
medicinal product and the adverse event.
Inês Vaz
(UFN - Unidade de
Farmacovigilância do
Norte)
Lunch
13h00-14h30
2.
14h30-16h30
16h30-17h00
17h00-19h00
collection, management and reporting of safety
information for investigational products
2.1. Drug safety during clinical trials; 2.2 Collection of AEs in
clinical trials; 2.3. Role of sponsors and investigators in reporting:
regulatory requirements
Dirk Teuwen &
Salvatore Curti
(UCB)
Coffee-break
2.4. Predisposing factors in health and disease; 2.5. Using MedDRA
terms; 2.6. EU and US regulations concerning safety data reporting
and data management.
Dirk Teuwen &
Salvatore Curti
(UCB)
DAy 02 09 MARCH
time
Programme
3.
Lecturer
collection and management of safety information
for marketed products
09h00-11h00
3.1. Why do we need Risk Management Plans (RMP)?
3.2. Legal Basis in EU and the US
3.3. Requirements for a RMP
3.4. The EU-RMP template
11h00-11h30
Coffee-break
11h30-13h00
3.5. Pharmacovigilance Studies, designing, conducting and reporting Madalena Arriegas
(European
post-authorization studies
Medicines Agency)
3.6.Risk Minimization Activities
3.7. Assessment and monitoring compliance
3.8. Case Studies
13h00-14h30
Lunch
4.
14h30-16h00
Madalena Arriegas
(European
Medicines Agency)
Safety information to regulatory authorities
4.1. Sources of safety information
4.2. Post-marketing safety requirements and spontaneous
expedited reporting in the EU and the US.
4.3. Electronic transmission
Ana Araújo
(INFARMED)
4.4. Dosage, accumulation, medication errors and interactions; drug
adherence/compliance.
Sandra Madaleno
(Pfizer)
16h00-16h30
Coffee-break
16h30-18h00
4.5. Periodic reporting in the EU and the US
4.6. Safety evaluation and implementation of safety measures:
Revocation, suspension, USR, SPC variation, communication to
HCP and general public.
Alexandra Pêgo
(INFARMED)
DAy 03 10 MARCH
time
Programme
5.
company’s drug safety and pharmacovigilance system
09h00-11h00
5.1. Company responsibilities for pharmacovigilance.
5.2. Pharmacovigilance and contractual agreements with third
parties.
5.3. The Qualified Person for Pharmacovigilance (QPPV) in the
European Economic Area.
5.4. Designing the company’s processes: SOPs.
11h00-11h30
Coffee-break
11h30-13h00
5.5. Pharmacovigilance inspections.
5.6. Crisis management.
5.7. Risk communication.
13h00-14h30
Lunch
6.
Lecturer
Helena Gama
(Bial)
Helena Gama
(Bial)
evaluating safety information and developing product labelling
14h00-17h00
6.1. Definition of a safety signal.
6.2. Regulatory requirements for signal detection, interpretation
and management.
6.3. Sources of signals.
6.4. Qualitative and quantitative methods of signal detection.
6.5 Signal evaluation, developing and managing company core
safety information and product labeling
Germano Ferreira
(Sanofi-Pasteur)
17h00-17h30
The role of the pharmaceutical professional in drug safety and
pharmacovigilance.
Alexandra Pêgo
(INFAMED),
Helena Gama (Bial),
Teresa Herdeiro (UA)
Module objectives:
• To provide an overview of medicinal products safety, from development to marketing.
• To present the principles and practice of pharmacovigilance, and the roles of the various
authorities/entities involved.
• To know post-marketing safety requirements and spontaneous reporting/electronic
transmission/periodic reporting.
• To evaluate the sources of signals and to know the regulatory requirements for signal detection,
interpretation and management.
Learning outcomes of the Module:
By the end of this module participants will be able to:
• Understand the need of assessing medicinal products safety, both during development and the
marketing period.
• Identify and classify adverse events and adverse drug reactions, evaluating the causality.
• Develop Risk Management Plans and Risk Minimization Activities, while considering their legal
and regulatory frameworks.
• Understand the procedures for Expedited Reporting Notification, both in the EU and in the US,
and periodic safety reporting.
• Assess drug safety information and identify options for action in response to safety signals.
• Discuss issues surrounding effective crisis management and the communication of drug safety
issues to Regulatory Authorities, Healthcare Professionals and the General Public.
• Develop pharmacoepidemiological studies and methods to evaluate drug safety.
Endorsed by the Associação de Médicos Portugueses da Indústria Farmacêutica