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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This is an on-demand recording from the February 2022 event.
The authors of RAPS new regulatory reference guide, Orphan Drug Development for Rare Diseases, will be on hand to discuss every aspect of orphan drug development, including:
This event is brought to you by:
Providing patients and health care practitioners with electronically delivered e-labeling is becoming increasingly important. Several regulatory authorities now permit and encourage online Electronic Patient Leaflet (e-PIL) content, with other regions following suit.
Ensuring content is delivered accurately in print and online formats, will be vital to ensuring patient safety, especially during the complex transition phase from printed-paper to electronic patient information. The evolution of e-labeling will rapidly progress from flat pdf facsimiles of the printed insert leaflet into interactive audio-visual presentations of information and must be planned for any e-PIL strategic initiatives.
Learn the essentials of e-PIL legislation, a pilot initiative between the pharmaceutical industry and the regulatory authorities in Belgium and Luxembourg, supported by the European Commission.
Upon the conclusion of the program, you will be able to:
Instructors:
Ashley Goldie, Aultra, Ltd.
Ashley is an experienced, detail-oriented professional and motivational leader, adept at working across the labelling and packaging creation process within the Life Science sector. Practiced in improving operational performance and leading enterprise labelling technology companies. Knowledgeable in; trend research, printed packaging, online content and directing activities to achieve extraordinary results.
Peter Muller, Schlafender Hase
For the last 25 years, Peter Muller has worked on software and process improvement projects relating to proofreading with Fortune 500 companies from various industries: Pharmaceutical, Medical Device, Chemical, Cosmetics & Consumer Goods. He has a wealth of experience working with international clients to define their organization's goals and help them leverage new technologies to achieve productivity gains, process improvements and cost savings.
For account support, contact the RAPS Support Center: +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.