Product Information for Medicinal Products in the EU 2017
In-Person Event
Jun 19 - 20, 2017
Zurich, Zurich, CHSpeakers
OVERVIEW
Product Information for Medicinal Products in the EU is organized by GlobalCompliancePanel and would be held during Jun 19 - 20, 2017 at Hilton Zurich Airport, Zurich, Switzerland.
Course Product Information for Medicinal Products in the EU" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview :
Regular review and monitoring of product information for medicines is important, to support awareness of relevant updates/changes which may affect prescribing, dispensing, administration or monitoring practices. It is also important that patients and caregivers, as appropriate, are made aware of the information contained in the Package Leaflet (PL) and should be encouraged to read it prior to and during their treatment.
Why should you attend :
Product Information is a key part of the marketing authorisation of all medicines authorised in the European Union
The product information is comprised of the Summary of Product Characteristics (SmPC) and the PL. These documents are issued when a medicine is first licensed for use and are reviewed and updated as necessary throughout the lifetime of a medicine, to reflect the current state of knowledge of the medicine and the risks associated with its use. The SmPC is mainly intended for use by healthcare professionals
Areas Covered in the Session :
• SmPC
• Package Leaflet
• Labelling
• Readability testing
Who Will Benefit :
Regulatory Affairs personnel involved in Product Information of medicinal products in the EU Agenda :
Day 1 Schedule
Lecture 1 :
The SmPC
• The role of the SmPC (including use as Pharmacovigilance Document)
• Where does the information come from?
• Structure of the Common Technical Document
• Structure of SmPC in reference to difference Modules
• Structure of SmPC in reference to departmental responsibilities (PV, Clinical, Quality, etc.)
• Relationship between Modules, SmPC, PIL, Labelling - the last three being the only key information seen by general public / med practitioners
• How to write an SmPC from scratch
• Presentation and discussion of key guidance documents (including templates) from EMA/CHMP The importance of writing the SmPC so that it will be precise, exact, readable, and unambiguous • Clarifying the therapeutic indications
• Listing contraindications
• Defining the warnings and precautions for use
• Highlighting potential drug interactions
• Defining instructions for proper use, improving tolerance to medicines by communicating necessary safety information and avoiding untoward effects
• Describing adverse reactions from clinical studies and spontaneous reporting and how it may influence pharmacovigilance
• Describing instructions for storage, shelf life and in use stability claims,
• Timing of reporting the date of last revision
• Translations
• The package leaflet
• Relationship between SmPC / Package Leaflet
• differences
• what is reflected where and in what format?
• The perception of risk of a medicinal product
• Guidelines for package leaflets
• Combining package leaflets for different pharmaceutical forms, presentations and strengths of a medicinal product
• The package leaflet as a marketing tool, what is allowed?
Lecture 2 :
• Practical exercises: Successfully working through the Regulations
• In this session, participants will be able to analyse the regulatory requirements and will gain an in-depth knowledge of how to meet them. The emphasis will be on grasping what information is required. This is a unique opportunity for the participants to ensure they fully understand and comply with the regulations in place.
Lecture 3 :
• Participants will work on the following points :
• Understanding what must be included in your Patient Information Leaflets (PLs) with a focus on safety
• Overcoming the special challenges when drafting the safety sections on contraindications, warnings and precautions
Lecture 4 :
• Practical exercise 1
• Writing a package leaflet, based on an SmPC
Lecture 5 :
• Practical exercise 2
• Improving a package leaflet, making it more clear and patient-friendly
Lecture 6 :
• Labelling
• Relationship between SmPC / Labelling
• Requirements for labels
• Minimum information on small labels
• Additional secondary packaging, e.g. Lilly contraceptives
• Labelling as a marketing tool, what is allowed?
Lecture 7 :
• Practical exercise 3
• Writing the label text, based on an SmPC
Day 2 Schedule :
Lecture 1 :
• Examining the legal issues surrounding the European regulations
• How must safety information be presented to the patient that would prevent very severe consequences such as foetus deformity - be included in leaflets?
• How does a company manage this by region?
• How often should a SmPC leaflet be reviewed? Relationship with PSURs.
• Risk-Management Plans and how they affect product information
Lecture 2 :
• Readability Testing
• Legal requirements
• Language requirements
• Where to test
• Pitfalls in developing a test
• Interviewing focus groups
• Bridging tests
• Inclusion and exclusion criteria
Lecture 3 :
• Practical exercise 4
• Conduct readability testing with the participants
Lecture 4 :
• Product Information during the registration procedures
• Before submission
• Steps to consider after submission and before marketing approval
• What to agree to and what not to agree to when negotiating with the Health Authorities
• What to do after CHMP opinion until EU Commission authorisation
Lecture 5 :
• Product Information after approval
• Overview of Variations
• Variations involving Product Information
• Variations for generic/hybrid/biosimilar products
• Variations following referrals
• Implementation of Pharmacovigilance requirements
• What to do with editorial changes?
• When to submit the translations
• Article 61(3) Notification
Lecture 6 :
• International situation
• Comparing US labelling, the Package Insert; also the complementary Medication Guide for the high risk drugs under a REMS
Speaker :
Adriaan Fruijtier
Regulatory Affairs Consultant, CATS Consultants GmbH
Adriaan Fruijtier has graduated as a pharmacist at the University of Utrecht, The Netherlands. He is currently Director Regulatory Affairs at CATS Consultants. Until March 2004 he has been Head of the Oncology Group within Global Regulatory Affairs at Bayer AG, Wuppertal, Germany, and Bayer Corporation, West Haven, CT, USA. Between 2001 and 2003 he was Director of Regulatory Affairs at Micromet AG, a biotech company in Munich, Germany. Prior to joining Micromet he has worked during four years as a Project Manager for Oncology Projects at the European Medicines Agency in London, United Kingdom.
Price :
Price: $1,895.00 (Seminar Fee for One Delegate)
Register for 5 attendees Price: $5685.00, $9,475.00 You Save: $3,790.00 (40%)
Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.
Course Product Information for Medicinal Products in the EU" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview :
Regular review and monitoring of product information for medicines is important, to support awareness of relevant updates/changes which may affect prescribing, dispensing, administration or monitoring practices. It is also important that patients and caregivers, as appropriate, are made aware of the information contained in the Package Leaflet (PL) and should be encouraged to read it prior to and during their treatment.
Why should you attend :
Product Information is a key part of the marketing authorisation of all medicines authorised in the European Union
The product information is comprised of the Summary of Product Characteristics (SmPC) and the PL. These documents are issued when a medicine is first licensed for use and are reviewed and updated as necessary throughout the lifetime of a medicine, to reflect the current state of knowledge of the medicine and the risks associated with its use. The SmPC is mainly intended for use by healthcare professionals
Areas Covered in the Session :
• SmPC
• Package Leaflet
• Labelling
• Readability testing
Who Will Benefit :
Regulatory Affairs personnel involved in Product Information of medicinal products in the EU Agenda :
Day 1 Schedule
Lecture 1 :
The SmPC
• The role of the SmPC (including use as Pharmacovigilance Document)
• Where does the information come from?
• Structure of the Common Technical Document
• Structure of SmPC in reference to difference Modules
• Structure of SmPC in reference to departmental responsibilities (PV, Clinical, Quality, etc.)
• Relationship between Modules, SmPC, PIL, Labelling - the last three being the only key information seen by general public / med practitioners
• How to write an SmPC from scratch
• Presentation and discussion of key guidance documents (including templates) from EMA/CHMP The importance of writing the SmPC so that it will be precise, exact, readable, and unambiguous • Clarifying the therapeutic indications
• Listing contraindications
• Defining the warnings and precautions for use
• Highlighting potential drug interactions
• Defining instructions for proper use, improving tolerance to medicines by communicating necessary safety information and avoiding untoward effects
• Describing adverse reactions from clinical studies and spontaneous reporting and how it may influence pharmacovigilance
• Describing instructions for storage, shelf life and in use stability claims,
• Timing of reporting the date of last revision
• Translations
• The package leaflet
• Relationship between SmPC / Package Leaflet
• differences
• what is reflected where and in what format?
• The perception of risk of a medicinal product
• Guidelines for package leaflets
• Combining package leaflets for different pharmaceutical forms, presentations and strengths of a medicinal product
• The package leaflet as a marketing tool, what is allowed?
Lecture 2 :
• Practical exercises: Successfully working through the Regulations
• In this session, participants will be able to analyse the regulatory requirements and will gain an in-depth knowledge of how to meet them. The emphasis will be on grasping what information is required. This is a unique opportunity for the participants to ensure they fully understand and comply with the regulations in place.
Lecture 3 :
• Participants will work on the following points :
• Understanding what must be included in your Patient Information Leaflets (PLs) with a focus on safety
• Overcoming the special challenges when drafting the safety sections on contraindications, warnings and precautions
Lecture 4 :
• Practical exercise 1
• Writing a package leaflet, based on an SmPC
Lecture 5 :
• Practical exercise 2
• Improving a package leaflet, making it more clear and patient-friendly
Lecture 6 :
• Labelling
• Relationship between SmPC / Labelling
• Requirements for labels
• Minimum information on small labels
• Additional secondary packaging, e.g. Lilly contraceptives
• Labelling as a marketing tool, what is allowed?
Lecture 7 :
• Practical exercise 3
• Writing the label text, based on an SmPC
Day 2 Schedule :
Lecture 1 :
• Examining the legal issues surrounding the European regulations
• How must safety information be presented to the patient that would prevent very severe consequences such as foetus deformity - be included in leaflets?
• How does a company manage this by region?
• How often should a SmPC leaflet be reviewed? Relationship with PSURs.
• Risk-Management Plans and how they affect product information
Lecture 2 :
• Readability Testing
• Legal requirements
• Language requirements
• Where to test
• Pitfalls in developing a test
• Interviewing focus groups
• Bridging tests
• Inclusion and exclusion criteria
Lecture 3 :
• Practical exercise 4
• Conduct readability testing with the participants
Lecture 4 :
• Product Information during the registration procedures
• Before submission
• Steps to consider after submission and before marketing approval
• What to agree to and what not to agree to when negotiating with the Health Authorities
• What to do after CHMP opinion until EU Commission authorisation
Lecture 5 :
• Product Information after approval
• Overview of Variations
• Variations involving Product Information
• Variations for generic/hybrid/biosimilar products
• Variations following referrals
• Implementation of Pharmacovigilance requirements
• What to do with editorial changes?
• When to submit the translations
• Article 61(3) Notification
Lecture 6 :
• International situation
• Comparing US labelling, the Package Insert; also the complementary Medication Guide for the high risk drugs under a REMS
Speaker :
Adriaan Fruijtier
Regulatory Affairs Consultant, CATS Consultants GmbH
Adriaan Fruijtier has graduated as a pharmacist at the University of Utrecht, The Netherlands. He is currently Director Regulatory Affairs at CATS Consultants. Until March 2004 he has been Head of the Oncology Group within Global Regulatory Affairs at Bayer AG, Wuppertal, Germany, and Bayer Corporation, West Haven, CT, USA. Between 2001 and 2003 he was Director of Regulatory Affairs at Micromet AG, a biotech company in Munich, Germany. Prior to joining Micromet he has worked during four years as a Project Manager for Oncology Projects at the European Medicines Agency in London, United Kingdom.
Price :
Price: $1,895.00 (Seminar Fee for One Delegate)
Register for 5 attendees Price: $5685.00, $9,475.00 You Save: $3,790.00 (40%)
Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.
KEY DATES
19 Jun, 2017
Event Start Date
20 Jun, 2017
Event End Date
SPECIALITIES
Healthcare ManagementHealthcare TechnologySUGGESTED HOTELS
CONFERENCE VENUE
Hilton Zurich AirportRELATED CONFERENCES & LIVE WEBINARS
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