2020-12-20 2021-10-21 , Online Online, 1.490,- € zzgl. MwSt. Dr. Peter Bachmann https://www.forum-institut.de/seminar/2110235-expertforum-labelling/referenten/21/21_10/2110235-course-expertforum-labelling_bachmann-peter.jpg ExpertFORUM Labelling

The annual labelling conference brings together authority and industry experts to address digital product information, structured data and safety labelling

Topics
  • Electronic product information (ePI)
  • Structured data - required for IDMP
  • Labelling challenges in the marketing authorisation
  • Safety labelling and educational material
  • End-to-end labelling - what is required for inspections
  • Digital medical information
Aims and objectives
We all experienced digitalisation in one way or another in 2020. This also pushed the issue of digital product information in the healthcare sector. An EU Common Standard will be developed as part of the ePI project, a major project now entering a new phase.

This conference addresses digital project information and the necessity for structured data. It also focuses on medical information, marketing authorisation and safety labelling.

Don't miss this labelling conference that provides the latest on labelling and digital product information. Digital transformation has only just begun!
Who should attend

This conference addresses the needs of individuals involved in product information in regulatory affairs, medical affairs and pharmacovigilance.

It provides useful updates on the relevant trends in digitalisation, safety labelling and much more. A working knowledge of product information is a prerequisite.

Course ExpertFORUM Labelling

ExpertFORUM Labelling

digital product information, structured data and safety labelling

Benefits
  • Medical affairs, regulatory affairs and pharmacovigilance addressed specifically
  • Digitalisation is one of the core topics - including ePI
  • We are following the IMI quality criteria

Webcode 2110235

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

20. - 21.10.2021

20. - 21.10.2021

Zeitraum

Day 1: 09:00-16:30Day 2: 09:00-13:30...

Day 1: 09:00-16:30
Day 2: 09:00-13:30
You may dial in 30 min. before the session
Veranstaltungsort

Online

Online

Gebühr
Ihr Ansprechpartner

Dr. Henriette Wolf-Klein
Head of Department

+49 6221 500-680
h.wolf-klein@forum-institut.de

Details

The annual labelling conference brings together authority and industry experts to address digital product information, structured data and safety labelling

Topics
  • Electronic product information (ePI)
  • Structured data - required for IDMP
  • Labelling challenges in the marketing authorisation
  • Safety labelling and educational material
  • End-to-end labelling - what is required for inspections
  • Digital medical information
Aims and objectives

We all experienced digitalisation in one way or another in 2020. This also pushed the issue of digital product information in the healthcare sector. An EU Common Standard will be developed as part of the ePI project, a major project now entering a new phase.

This conference addresses digital project information and the necessity for structured data. It also focuses on medical information, marketing authorisation and safety labelling.

Don't miss this labelling conference that provides the latest on labelling and digital product information. Digital transformation has only just begun!

Who should attend

This conference addresses the needs of individuals involved in product information in regulatory affairs, medical affairs and pharmacovigilance.

It provides useful updates on the relevant trends in digitalisation, safety labelling and much more. A working knowledge of product information is a prerequisite.

Detailed programme

Day 1: 09:00-16:30
Day 2: 09:00-13:30
You may dial in 30 min. before the session

09:00 Introduction


09:15

Dr Peter Bachmann

Electronic product information (ePI) - current status in the EU and worldwide
  • The common EU standard
  • The future of multilingual packaging
  • Second- and third-generation machine translation
  • Worldwide e-labelling initiatives

10:15 Coffee break


10:30

Berit Fasse

ePI from a company perspective
  • Structured labelling: Does it also enhance readability

11:20 Short break


11:30

Karl-Heinz Loebel

Structured data - required for IDMP and better labelling
  • Current implementation status of IDMP
  • Collecting, cleaning and structuring data within companies

13:00 Lunch break


14:00

Kim Sherwood

ePI user cases
  • ePI and the readability guideline
  • ePI and the QRD templates

15:00 Coffee break


15:15

Dr Eva Göbgen

GI 4.0 - The German project in the context of the EU pilot
  • Project governance
  • Five years of experience
  • Future development

16:00 Final discussion


16:30 End of day one


09:00

Susanne Winterscheid

Labelling challenges in decentralised procedures
  • Experiences with multilingual packaging, current pilot

10:00 Short break


10:10

Dr Thomas Grüger

Safety labelling and educational material in Europe
  • Readability testing for educational material
  • From signal detection to labelling - current challenges

11:00 Coffee break


11:15

Lynsey Flitton

End-to-end labelling and safety implementation process
  • Implementation into pack and online
  • Expectation for inspections of implementation tracking

12:10 Short break


12:20

Dr Eva Löw

From labelling to comprehensive medical information
  • Medical Information goes digital
  • Medical content - push and/or pull

13:15 Final discussion


13:30 End of the online conference


Your takeaways

Why you should attend

  • An intensive exchange between authority and industry experts
  • Medical affairs, regulatory affairs and pharmacovigilance addressed specifically
  • Digitalisation is one of the core topics - THE challenge in the coming years

FAQs/What are the system requirements?

You need a reliable Internet connection and a browser. The following Windows browsers are applicable:

  • Internet Explorer 8 onwards
  • Mozilla Firefox
  • Google Chrome

_______________

We recommend you use the Zoom app to connect with your mobile device.
You will need a headset, loudspeakers or a telephone for audio.

_______________

Can I test my equipment beforehand?
Yes, you can check whether everything will work properly on the day of your online training.
Just click the following link to run a test: https://zoom.us/test

_______________

Do I have to use a headset for the online seminar?
No. In addition to all popular microphones and loudspeakers, Zoom also supports dial-in access by telephone. However, working with a headset is much more convenient for online seminars.

How does an online seminar work?

The Zoom webcasts are live and interactive. They are held and controlled directly by our speaker. You may take part in the seminar from anywhere using your end device. You will see the presentation and listen to our speaker's lecture using Internet telephony (VoIP) or even a normal telephone connection. And you can also ask questions live, using the chat function.

1. You will receive brief instructions on how to use Zoom online seminars beforehand.
2. Use a headset, loudspeakers or the telephone for audio.
3. Listen to the speaker and follow the presentation.
4. Use the chat function to ask questions.

The benefits of an online seminar

  • Attend the webcasts in all comfort, from wherever you like
  • There are no travel and accommodation costs
  • Ask questions live, using the chat function

This distinguishes our events

Overall impression: 100 % of the participants' feedback was very good or good (May 2019)

Course content: 100 % of the participants' feedback was very good or good (May 2019)

Recommendations

Aufbauwissen für den Großhandelsbeauftragten

Virtuelles Aufbauseminar zu weitergehenden Verantwortlichkeiten und Pflichten des Großhandelsbeauftragten

09.11.2021, Online
Details

Kennzeichnung, Verpackung und Marketing von Kosmetika

Dieser Online-Kurs bietet einen umfassenden Überblick über den regulatorischen Rahmen der Kennzeichnung, Verpackung und ...

26.10.2021, Online
Details

GMP-/GDP-Auditor

Das "missing link" unter den Lehrgängen - wir schließen die Lücke und schulen Sie in unserem Zertifikatslehrgang zum GDP...

20. - 21.10.2021, Online
Details

GMP-/GDP-Auditor

DIE Online-Weiterbildung zum zertifizierten GMP-Auditor!

18. - 19.10.2021, Online
Details

Großhandelsbeauftragte

Ein Seminar über die verantwortlichen Personen von pharmazeutischen Unternehmen und des Großhandels - die Aufgaben, Vera...

09.12.2021, Online
Details

Go forward

Pharma FORUM Webcast International

International experts will inform you of the latest trends in global marketing authorisation and drug safety.

Details
Pharma Webcast Global RA & PV
e-Learning - Click and learn

The FORUM · Institut für Management GmbH provides flexible education and training with high-quality e-Learning programme...

Details
e-Learning
Quality guaranteed!

Your feedback produced as result of 1.7 in 2020. Thank you!

Details
More on our quality criteria

Testimonials

This was well received by the participants in May 2019
Focus on electronic product info

Torsten Niemann

medac Gesellschaft für klinische Spezialpräparate mbH


Experienced speakers, good overview, sufficient links to further info


Abwechslungsreicher Inhalt


Interessting nw information about future perspectives


Information about ePi