2024
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
2023
Seminar Labelling Management & Artwork
Package leaflet, artwork and quality control compacted
SmPC, Package Leaflet, Labelling Online Training
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
Application procedures, variations, regulatory documentation
2022
Forum Seminar Online: Regulatory Affairs
Application procedures, variations, regulatory documentation
2021
Forum Seminar Online: Labelling Management & Artwork
Package leaflet, artwork and quality control compacted
Forum Seminar Online: SmPC, package leaflet, packaging - the essentials
Basic knowledge for the generation of SmPCs & package leaflets as well as information on the design of the packaging
Forum Seminar Online: Regulatory Affairs
Application procedures, variations, regulatory documentation
Forum Seminar Online: Scientific English Writing and Reviewing in Regulatory Affairs
Free writing, regulatory restrictions, regulatory documents, user-friendly writing
Forum Seminar Online: Regulatory Affairs
Application procedures, application changes, regulatory documentation
Forum Seminar Online: Labelling Management & Artwork
Package leaflet, artwork and quality control compacted
2020
Forum Seminar: The labelling manager (2)
Regulatory requirements for package inserts and packaging, artwork management
Forum Seminar: The labelling manager (1)
Regulatory requirements for package inserts and packaging, artwork management
Forum Seminar: Scientific Writing and Reviewing in Regulatory Affairs
Update your English writing skills - with many practical exercises
2019
DGRA-Workshop - Productinformation and Labelling
Patient‘s expectations, Patient compliant packaging, Regulatory aspects, PI and medication errors, Electronic leaflets and mobile technologies
Forum Seminar: Scientific Writing and Reviewing in Regulatory Affairs
Update your English writing skills - with many practical exercises
Forum Seminar: Product information
SmPC, package insert, labeling - the essentials
Forum Seminar: The labelling manager
Package leaflet, artwork and quality control - condensed
2018
Forum Seminar: Product information
SmPC, package insert & labeling
2017
Forum Seminar: Product information
Generation of SmPCs, package inserts, labeling
Forum Seminar: QRD Template Workshop
Implementation, company-internal adjustments, practical exercises
2015
Forum seminar: Labeling, package insert and QRD-Templates, Bonn, Germany
Expirience with readability user testing (RUT), using QRD templates
Forum seminar: Package insert - seminar for experts
Use of sample/reference texts and QRD templates, practical exercises for using the QRD template, readability user testing and bridging studies
2014
Forum training: Labeling, package inserts and QRD templates, Bonn, Germany
Use of QRD templates, questions relating to labeling
2013
Forum seminar: Labeling, package inserts and QRD templates, Bonn, Germany
Use of QRD templates
12th EGA Regulatory and Scientific Affairs Conference, London, United Kingdom
Learning from current experience - did readability tests improve the quality of information and satisfy patients‘ needs?
2012
Pharma Packaging 2012, 6th annual meeting, Berlin, Germany
The new QRD templates for product information
Forum seminar: Labeling, package insert and QRD templates, Bonn, Germany
Using the new QRD templates
2011
Meeting of the Association of the European Self-Medication Industry (AESGP), London, United Kingdom
The ideal OTC package insert
Forum seminar: Labeling, package inserts and the coming QRD templates, Bonn, Germany
The coming QRD templates
Pharma Packaging 2011, 5th annual meeting, Berlin, Germany
Readability Guideline & Labelling: Recent experience on implementation and readability tests
2010
Training program for Chinese Medicines Agency (State Food and Drug Administration), Bonn, Germany
Patient information via package inserts within the European Union
Pharmaceutical Colloquium at the Institute of Pharmacy, Bonn, Germany
User friendly patient information via package inserts - status and perspectives
2008
Joint EMEA - CMDh - DIA workshop on package insert user testing, London, United Kingdom
The way forward on user testing - CRO's perspective
2007
The Pharmaceutical Appliance and Epidemiology Research Associations (GAA) 14th annual meeting, Frankfurt/Main, Germany
Is splitting tablets an appropriate method to save medical costs
Colloquium Pharmaceuticum, Frankfurt/Main, Germany
Comprehensible package inserts and SmPC writing
2006
The Pharmaceutical Appliance and Epidemiology Research Associations 13th Annual meeting (GAA), Berlin, Germany
Package inserts and their influence on drug safety and therapy success
BfArM (Federal Institute for Drugs and Medical Devices) in the dialogue regarding package inserts in a European context and the new legal requirements, Bonn, Germany
Developing and testing an instrument to evaluate and optimise package inserts
2005
The major vaccination advice project in Thuringian pharmacies, Germany
Workshop
The vaccination advice project in Brandenburg pharmacies, Germany
Vaccination advice in pharmacies
Training for employees of pharmacies to carry out the large vaccination advice in Thuringian pharmacies, Erfurt, Germany
Vaccination advice in pharmacies: workable, efficient, essential
2004
DPhG annual meeting, Regensburg, Germany
Improving package inserts to increase patient compliance
2nd German Patient Law Day, Frankfurt/Main, Germany
Information for patients - many package inserts have deficiencies
13th international social pharmacy workshop, Malta - Programm
Package inserts and their comprehensibility for patients
3rd German congress of health care research, Bielefeld, Germany
Optimisation of package inserts to improve information and compliance