Description of event:
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.
The PL reflects the more comprehensive information described in the SmPC, but is required to be presented in an abbreviated and easyto-read format for patients.
The SmPC provides the basis of information for healthcare professionals to use a medicine
safely, effectively and in the most appropriate manner. It is also a legal document, agreed between the Authorities and the relevant pharmaceutical
The format and content of the SmPC is laid down in EU/national legislation and regulatory guidance documents. Use of a medicine
outside the conditions/ recommendations described in the SmPC falls under the responsibility of the healthcare professional.
It is important to note that the SmPC is not intended to provide general advice on the treatment of particular medical conditions. On the other hand, specific aspects of the treatment related to use of the medicine
, or its effects may be mentioned. Similarly, general advice on administration procedures is not included, but any advice specific to the medicine
concerned will be included, if appropriate.
The PL is drawn up in accordance with the SmPC and is subject to user-testing to ensure its ease of readability by patients/consumers. It plays an essential part in supporting the safe and effective use of a medicine
by a patient. Consequently, it is important that a PL is provided each time a product is dispensed. Patients and care-givers should be encouraged to read the current
version of the PL that accompanies their medicine
(s) and to discuss any relevant concerns with a healthcare professional involved in their care.
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
SmPCs are also the basis for the preparation of package leaflets, so are important documents in enabling information on medicines to reach patients.
and package leaflet are important tools to achieve correct use of the medicinal product. Marketing Authorisation Holders (MAHs) are required to ensure that current
versions of the labelling
and package leaflet are used when medicines are supplied to pharmacies.
Areas Covered in the Session:
• Package Leaflet
• Readability testing
Who Will Benefit:
• Regulatory Affairs personnel involved in Product Information of medicinal products in the EU
Day 1 Schedule
• 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
• Listing contraindications
• Defining the warnings and precautions for use
• 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
• The package leaflet
• Relationship between SmPC / Package Leaflet
• 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?
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.
Participants will work on the following points:
Understanding what must be included in your Patient Information Leaflets (PLs) with a focus
Overcoming the special challenges when drafting the safety sections
on contraindications, warnings and precautions
Practical exercise 1
• Writing a package leaflet, based on an SmPC
Practical exercise 2
• Improving a package leaflet, making it more clear and patient-friendly
Minimum information on small labels
• Additional secondary packaging, e.g. Lilly contraceptives
as a marketing tool, what is allowed?
Practical exercise 3
Writing the label
text, based on an SmPC
Day 2 Schedule:
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.
Plans and how they affect product information
• Legal requirements
• Language requirements
• Where to test
• Pitfalls in developing a test
• Bridging tests
• Inclusion and exclusion criteria
Practical exercise 4
• Conduct readability testing with the participants
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
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
Comparing US labelling
, the Package Insert; also the complementary Medication Guide for the high risk drugs
under a REMS
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.
He joined the European Medicines Agency from Novartis AG, Basel, Switzerland, where he was Regulatory Affairs Project Manager in the Oncology
group in 1996 and 1997.
Before 1996 he was Head of Drug
Regulatory Affairs for six years at Ciba-Geigy in the Netherlands, and has worked as Manager Regulatory Affairs at Glaxo, also in the Netherlands.
Location: Boston, MA
Venue: Courtyard Boston Logan Airport, 225 William F. McClellan Highway - Boston, Massachusetts 02128 USA
Date: January 21st & 22nd, 2016 and Time: 9:00 AM to 6:00 PM
Price: $1,295.00 (Seminar for One Delegate)
Register now and save $200. (Early Bird)
Until December 20, Early Bird Price: $1,295.00 from December 21 to January 19, Regular Price: $1,495.00
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161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.