This document discusses the information available to patients once a medicine is authorized, including the product information and European Public Assessment Report (EPAR). It outlines the involvement of patients and consumers in reviewing elements of product information like package leaflets and EPAR summaries. The review process aims to ensure information is clear, understandable, and meets public needs. Patient and consumer organizations provide input on draft documents to assess language use, explanations, and identify unnecessary or missing information from a lay perspective. Their comments notably differ from other reviews and often lead to text changes or revisions for future documents.
TIMELINE
PHARMACOVIGILANCE STAKEHOLDERS
ERMS – RECOMMENDATIONS 2005 – KEY CHANGES
2006 CONSULTATIONS – 2008 PROPOSALS
NEW DIRECTIVE 2010/84/EU
PHARMACOVIGILANCE
New regulation (EC) No 726/2004
PHARMACOVIGILANCE OF HUMAN MPs
PHARMACOVIGILANCE OF VETERINARY MPS
MILESTONES 2011-2012
REGULATION (EU) 520/2012
ICH GUIDELINES
GPvP GUIDELINES
MILESTONES – FURTHER DEVELOPMENT
TIMELINE
PHARMACOVIGILANCE STAKEHOLDERS
ERMS – RECOMMENDATIONS 2005 – KEY CHANGES
2006 CONSULTATIONS – 2008 PROPOSALS
NEW DIRECTIVE 2010/84/EU
PHARMACOVIGILANCE
New regulation (EC) No 726/2004
PHARMACOVIGILANCE OF HUMAN MPs
PHARMACOVIGILANCE OF VETERINARY MPS
MILESTONES 2011-2012
REGULATION (EU) 520/2012
ICH GUIDELINES
GPvP GUIDELINES
MILESTONES – FURTHER DEVELOPMENT
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European Medicines Agency (EMA)
It is a decentralized agency of the European union.
The Management Board is the European Medicines Agency’s integral governance Body.
The Agency is responsible for the scientific evaluation, supervision and safety monitoring of the medicines developed by pharmaceutical companies use in EU.
EMA protects public and animal health in 27 EU member states, as well as the countries of the European economic area , by ensuring that all medicines available on the EU market are safe, effective and of high quality.
History
European medical agency was found in 1995, has worked across the EU and globally to protect public and animal healty by assessing medicines to rigorous scientific standards and providing with independent, science-based informations on medicines.
EMA has 20 year track record of ensuring efficacy and safety of human and veterinary medicines across Europe, and promoting research and innovation in the developments of medicines.
In first two decades, the agency recommended the authorization of the total of 975 humans and 188 veterinary medicines.
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The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
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Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
1. An agency of the European Union
Nathalie Bere
Patient interaction - Stakeholder and Communication Division
Workshop on the review of product information at
the EMA by patients
EURORDIS Summer school 2015
2. 1
What information is available once a medicine is authorised?
A. Product information
• Part of the marketing authorisation
– Legal basis
– Agreed with the company during evaluation
– Re-assessed and updated during medicine’s life cycle
• Consists of:
– Summary of product characteristics (SmPC)
Addressed to prescribers and pharmacists
– Package leaflet
Addressed to patients (included in each package)
– Labelling
Information on the outside of the packaging
3. 2
B. European Public Assessment Report (EPAR)
• Set of documents explaining how the Committee reached its recommendations
• Published for each centrally authorised medicine
• Consists of:
1. Summary for the public
2. List of authorised presentations
3. Committee’s assessment report
4. Steps taken before and after authorisation
5. Product information (annexed)
What information is available once a product is authorised? (Cont.)
4. 3
Other documents prepared for the public
• Safety communications (convey an important (emerging) message relating to a
medicine once authorised)
– withdrawal or suspension from the market for safety reasons;
– new contraindication or warning;
– product defect
– Potential supply shortage
• Other general communications
• Press releases
Decisions on communication are made on a case-by-case basis
5. 4
Publishing and sharing information
• All documents are published on Agency website
• Communications are actively sent out to mailing lists at time
of publication
• Sent to patients’ representative for further dissemination
6. 5
Involvement of patients and consumers
• Patients and Consumers are involved in many aspects of the Agency’s work
• Review of information on products since 2007
– Package leaflets
newly authorised medicines
renewals of marketing authorisation
– EPAR summaries
newly authorised
– Safety related communications
all
7. 6
CHMP
CAT
PRAC
CHMP-
SAWP
CHMP
PRAC
Orphan
Designation
Scientific Advice
Protocol assistance
Paediatric
Investigation
Plan
Post Marketing
Authorisation
Marketing Authorisation
Application Evaluation
COMP PDCO
CAT SAGSAG
Patient
input
Patient
input
Patient
input
Patient
input
Public
Summaries
of Opinion
Patient
input
Package Leaflets (PL)
EPAR summaries
Safety
Communications
Patient
input
Patient
input
Patient
input
Patient
input
Patient
input
DocumentsforthePublicRegulatoryProcedureCommitteesandWorkingParties
Package Leaflets (PL)
(renewal)
Patient
input
Patient
input
Opportunities for Patient involvement along the medicine lifecycle at EMA
8. 7
Principles for the involvement in review process
• The purpose of the review is to ensure that the information is clear and understandable
for “lay people”, and that it fulfils the public’s needs in terms of information content
• All documents for review are confidential until they are made public; all experts must
have signed confidentiality undertaking
• The documents are exchanged by Eudralink e-mail
10. 9
What are EPAR summaries? (cont.)
• They do not replace product information (which includes the package leaflet)
• Full EPAR includes product information as well as CHMP Assessment Report
• Required by EU law to be published along with the full EPAR
12. 11
How EPAR summaries are
prepared
• Documents used for preparation
– Product information
– Adopted CHMP assessment reports
– Internal style guide
– Glossary of medical terms
13. 12
The review process
• Medical writers
• EMA product team
• Patient and consumer organisations (PCOs)
• Rapporteur and Co-Rapporteur (assessors)
• Company
14. 13
Why the patient/consumer review?
• Patient/consumer perspective
• Patients and public concerns
• Only review without source documents
• Appropriate use of language
• Quality check
15. 14
Things to look out for
• Complicated/oversimplified language
• Unexplained scientific terms
• Inappropriate explanations
• Unnecessary/missing information
• Confusing numbers
• Do you understand the main benefits?
• Do you understand basis for approval?
16. 15
Patient/consumer comments
• All comments are considered
• Write what you think/feel
• Comments can be in any form:
– General or specific
– Text changes (tracked)
– Suggestions
– Questions
17. 16
Impact of patient/consumer review
• Comments are noticeably different from other reviews
• On average half of comments lead to text changes
• Many implemented with modifications
• Some not implemented immediately but are used for future reference for changing
templates and standard definitions
