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Seminar on Product Information for Medicinal Products in the EU 2017

Monday, Jun 19, 2017 at 9:00AM - Tuesday, Jun 20, 2017 at 6:00PM


  • Jun 2017

    19 Mon


  • Jun 2017

    20 Tue


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Seminar on Product Information for Medicinal Products in the EU 2017

Monday, Jun 19, 2017 at 9:00AM - Tuesday, Jun 20, 2017 at 6:00PM


No tickets available

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.


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 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.

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.

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:

  • SmPC
  • Package Leaflet
  • Labelling
  • Readability testing

Who Will Benefit:

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


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
  • Clarifying the therapeutic
  • Listing
  • 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
  • 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

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
  • 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

  • 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
  • Interviewing focus
  • Bridging tests
  • Inclusion and exclusion

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
  • Implementation of
    Pharmacovigilance requirements
  • What to do with
    editorial changes?
  • When to submit the
  • Article 61(3)

Lecture 6:

International situation

  • Comparing US labelling,
    the Package Insert; also the complementary Medication Guide for the high
    risk drugs under a REMS



Regulatory Affairs Consultant, CATS Consultants

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: Zurich, Switzerland Date:June 19th
& 20th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: Hilton Zurich

Address: Hohenbuhlstrasse
10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50




Price: $1,695.00 (Seminar Fee for One Delegate)


Register for 5 attendees Price: $5085.00 $8,475.00
You Save: $3390.00 (40%)*


Until May 10, Early Bird Price: $1,695.00 From May 11
to June 17, Regular Price: $1,895.00


Quick Contact:

NetZealous DBA as


Phone: 1-800-447-9407

Fax: 302-288-6884



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