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Seminar on Product Information for Medicinal Products in the EU  

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Global Compliance Panel   


Regulatory Affairs personnel involved in Product Information of medicinal products in the EU


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Training Course Syllabus:

Product Information for Medicinal Products in the EU


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 easy to-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 company.
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 authorization of all medicines authorized 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.

The labelling 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


Day 1 Schedule

Lecture 1:
The SmPC
The role of the SmPC (including use as Pharmacovigilance Document)
Where does the information come from?
o Structure of the Common Technical Document
o Structure of SmPC in reference to difference Modules
o Structure of SmPC in reference to departmental responsibilities (PV, Clinical, Quality, etc.)
o 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
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?

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:
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


Adriaan Fruijtier
Regulatory Affairs Consultant, CATS Consultants GmbH
Adriaan Fruijtier has graduated as a pharmacist at the University of Utrecht, The Netherlands.

Seminar Summary:

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