Messages

Seminar Labelling Management & Artwork

19. - 20. February 2025 - Online

ExpertFORUM Labelling

23. - 24. Oktober 2024 - Online conference on current labelling topics

Regulatory Affairs Online Training, Package Leaflet

Live-Online-Workshop 12.03., 09.04.,16.05.2024: Application procedures, variations, regulatory documentation – Creation and updating of package leaflets

Seminar Labelling Management & Artwork

6. - 7. Februar Online: Regulatory requirements for package leaflet and artwork, artwork management

Seminar Labelling Management & Artwork

Package leaflet, artwork and quality control

Regulatory Affairs Online Training, Package Leaflet

Application procedures, variations, regulatory documentation – Creation and updating of package leaflets

ExpertForum Labeling

Interview von Dr. Jörg Fuchs zur Packungsbeilage: Wir werden immer nur einen Kompromiss haben

ÄrzteZeitung, 2023 (34)

Seminar Labelling Management & Artwork

29 - 30 August 2023: Package leaflet, artwork and quality control compacted

SmPC, Package Leaflet, Labelling Online Training

26 September 2023: Basic knowledge for the generation of SmPCs & package leaflets as well as information on the design of the packaging

Regulatory Affairs Online Training, Package Leaflet

22 March - 23 May 2023: Application procedures, variations, regulatory documentation

Forum Seminar online: Regulatory Affairs

14 March - 24 May 2022, live-online-workshops: application procedures, variations, regulatory documentation

Forum Seminar Online: Labelling Management & Artwork

15 - 16 February 2022, online: Package leaflet, artwork and quality control compacted

Forum Seminar Online: SmPC, package leaflet, packaging - the essentials

1 December 2021: Basic knowledge for the generation of SmPCs & package leaflets as well as information on the design of the packaging

Forum webcast-series: Regulatory Affairs

13 October - 14 December, live-online-workshops: application procedures, variations, regulatory documentation

Forum Seminar Online: Scientific English Writing and Reviewing in Regulatory Affairs

29 - 30 September 2021: Lectures, practical hands-on exercises and text review sessions

Forum Seminar Online: Labelling Management & Artwork

8 - 9 September 2021, online: Package leaflet, artwork and quality control compacted

Forum Seminar Online: Regulatory Affairs

Application procedures, application changes, regulatory documentation

Design Science with a Focus on User-Centred Evaluation of Written Information

Communicating about Risks and Safe Use of Medicines - Real Life and Applied Research

Forum Seminar: The labelling manager

24 - 25 September 2020 in Heidelberg, Germany - Regulatory requirements for package inserts and packaging, artwork management, GMP-compliant documentation and quality control, IDMP, SPOR, XEVMPD - maintain product information online, labelling in the focus of audits and inspections

Forum Seminar: The labelling manager

5 - 6 March 2020 in Frankfurt, Germany - Regulatory requirements for package inserts and packaging, artwork management, GMP-compliant documentation and quality control, IDMP, SPOR, XEVMPD - maintain product information online, labelling in the focus of audits and inspections

Statement relating to the Report from the CMDh meeting, 24-26 March 2020 - Covid-19 and user testing

COVID-19 outbreak and user testing of package leaflets

Forum Seminar: Scientific Writing and Reviewing in Regulatory Affairs

17 - 18 Februar 2020 in Frankfurt, Germany - Update your English writing skills - with many practical exercises: After completing this seminar, participants will be aware of the key regulatory requirements when preparing texts, with a greater awareness of the importance of proper English writing, reviewing and proofreading processes. Practical…

Forum Seminar: Product information texts

3 December 2019 in Berlin, Germany - Completing this seminar deems you legaly fit to prepare SmPCs, package inserts and in the labelling of the packaging. You learn the scopes and limits of preparation and receive solution options.

DGRA-Workshop - Productinformation and Labelling

27 - 28 November 2019 in Bonn, Germany - Patient‘s expectations, Patient compliant packaging, Regulatory aspects, PI and medication errors, Electronic leaflets and mobile technologies

Forum Seminar: The labelling manager

24 - 25 June 2019, Mannheim, Germany - This seminar delivers profound know-how of the labelling process chain from preparation of the package insert, the artwork and the packaging up to GMP-relevant aspects. Afterwards, you are up-to-date with regulatory requirements.

Forum Seminar: Scientific Writing and Reviewing in Regulatory Affairs

9 - 10 April 2019 in Frankfurt, Germany - Update your English writing skills - with many practical exercises: free writing versus regulatory restrictions; editing and proofreading documents; package leaflet - regulatory linguistic restrictions and user-friendly writing.

Readability test results from the PAINT3 study: Should package leaflets be coloured in the future?

The use of colour to emphasise important information and headings of package leaflets has been recommended in the EU readability guideline since 1998. Our study investigated the advantages and disadvantages of coloured and black/greyscale versions. The results show that both options are appropriate for package leaflets.

Forum Seminar: Product information

28 June 2018 in Cologne, Germany, and 4 December 2018 in Berlin, Germany - Product information: SmPC, package insert and labelling

Typographic changes in package leaflets of the European Union based on the example of German versions between 2005 and 2015

Using German package leaflets over the period from 2005 to 2015 as example, the study results show significant improvements, such as the increase in font sizes, line spacing and the more frequent use of highlighting. However, a significant increase in the volume of text has been found.

Forum Seminar: product information

28 - 29 June in Berlin, Germany, 7 - 8 December 2017 in Cologne, Germany - Product information, including workshop to prepare SmPC, package insert and labelling

Forum workshop: QRD template

26 January 2017, Cologne, Germany - QRD template implementation, company-internal adjustments, practical exercises

Landscape versus portrait format in package leaflets - Which format is more suitable according to readability test results from the PAINT3 study?

The results in the written readability test with 234 participants do not show an advantage of the landscape format over the portrait format. This finding negates the EU readability guideline’s stated preference for the landscape format.

Implementation of the European Union QRD template in package leaflets of centralised approved medicines

Our analysis over 3 years of all English-language package leaflets available on the EMA website showed a significant text increase in package leaflets, whereby one mean reason is the huge text increase of the QRD template.

Research concerning handling the ongoing volume of text increase in package leaflets

Resource-saving solutions that additionally guarantee a good standard of legibility for package leaflets, such as text compression and targeted paper selection, can be found in the following.

Extensive research published concerning the QRD template

Dr. Anna Wolf finalised her extensive work in February 2015 concerning the QRD template of the European Union, under PAINT-Consult’s supervision at the University of Bonn.

Opacity study by PAINT-Consult

The results of two investigations of 258 randomly selected German package leaflets show that opacity is a more appropriate tool for assessing paper quality than the paper weight recommended in the readability guideline.

List of MAH representatives in package inserts is no longer required

Since QRD template version 9.1 this list is no longer essential.

Forum seminar: Labeling, package insert and QRD templates

26 - 27 February 2015, Bonn, Germany - Workshop: experience with readability user testing, using QRD templates

Forum training: Labeling, package inserts and QRD templates

10 - 12 February 2014, Bonn , Germany - Workshop: use of QRD templates, questions relating to labeling

Move into larger, company-owned premises

Address: Wenigenjenaer Ufer 12, 07749 Jena, Germany

12th EGA Regulatory and Scientific Affairs Conference

17 - 18 January 2013, London, United Kingdom - Presentation: Learning from current experience - did readability tests improve the quality of information and satisfy patients' needs?

Our ongoing effort, since 1999, to improve the comprehensibility of package inserts continues to yield results.

The Forsa Opinion Research Institute, acting on behalf of the ERGO Insurance Group AG, interviewed 2600 people. The results show that package inserts are the most comprehensible product information in Germany.

Pharma Packaging 2012, 6th annual meeting

14 February 2012, Berlin, Germany - Presentation: The new QRD templates for product information

Two studies of the QRD template published by PAINT-Consult

PAINT-Consult developed a model template with only 200 words, which has significant advantages over the QRD template (PDF). In a second study, the development of the QRD template from 1996 to 2012 was analysed (PDF).

Meeting of the Association of the European Self-Medication Industry (AESGP)

6 April 2011, London, UK - Presentation: The "ideal" OTC package insert

Pharma Packaging 2011, 5th annual meeting

14 February 2011, Berlin, Germany - Presentation: Readability Guideline and Labelling: Current experience on implementation and readability tests.

CMDh position paper: PAINT-Consult's written readability test method is once again acknowledged

CMDh once again recommended PAINT-Consult's written readability test method as an alternative

Training program for Chinese Medicines Agency (SFDA)

26 November - 3 December 2010, University of Bonn, Germany - Presentation: Patient information via package inserts within the European Union

Dissertation University of Bonn, Department of Drug Regulatory Affairs

Supervised by PAINT-Consult, Dr. Claudia Hertzsch completed her dissertation relating to: Possibilities and limitations in preparing patient-friendlier package inserts with regard to content, formal design and amount of text.

MHRA again confirms acceptance of our written readability test

PAINT3 study

PAINT-Consult completes the PAINT3 study - a readability test study of 271 randomly selected German package inserts with 5091 participants.

European Commission demand a minimum font size of 9pt as recommended by PAINT-Consult

In the readability guideline (PDF) the European Commission stipulated a minimum font size of 9pt as recommended by PAINT-Consult, instead of the originally intended 12 to 20pt (PDF). This is based on the font size study of PAINT-Consult published in May 2008 (PDF).

Joint DIA – EMEA – CMD(h) workshop on user testing

5 December 2008, London, United Kingdom - Presentation: The way forward on user testing - CRO's perspective

PAINT2 study

PAINT2 study is accomplished. This is an analysis of 271 package inserts randomly chosen from those available on the German medicine market in 2005.

Frequency explanations of side effects developed in the PAINT1 study are recommended throughout the European Union

Vaccination advice in Mecklenburg-Western Pomerania, Germany

Scientific leadership of the large vaccination advice campaign for pharmacies in Mecklenburg-Western Pomerania (Germany) during 2007, including training courses for pharmacy staff

Europe-wide acceptance of the written readability test developed and used by PAINT-Consult

Vaccination advice in Brandenburg, Germany

Scientific leadership of the large vaccination advice campaign for pharmacies in Brandenburg (Germany) during 2007, including training courses for pharmacy staff

Vaccination advice in Thuringia, Germany

Scientific leadership of the large vaccination advice campaign in pharmacies throughout Thuringia (Germany) during 2005, including training courses for pharmacy staff

The PAINT-Consult company is formed

PAINT1 study

The PAINT1 study is accomplished. Using a cross-over study design and the written readability test, the PAINT1 study investigated five original and five model package inserts with 1105 participants.

Dr. Jörg Fuchs commences intensive research and scientific studies into package inserts and readability tests