E-labeling is no longer a future concept. Regulatory agencies worldwide, including the EMA, FDA, and MHRA, are advancing digital product information initiatives. But what does this mean for your daily work as a regulatory professional? How will your submission and labeling processes change? And how can you prepare today to avoid last-minute compliance risks?
Watch the webinar below to gain clarity on the changes you can expect with digital product initiatives and learn how you can make the transition smoother.
Learning Objectives
- Understand the global shift to e-labeling.
- Why regulators are pushing for it and what’s happening in key markets like the EU, US, and UK.
- Explore how e-labeling will impact your daily work.
- What’s changing in submission workflows, approval processes, and content management.
- Use Case Spotlight: Learn how Rote Liste supports converting existing pharmaceutical data into structured ePI content, ensuring compliance with EMA guidelines.
Watch On Demand:
Speakers:
Mike Baird – Director of Product Management at Schlafender Hase
Mike is committed to continuously improving the existing software portfolio and at the same time also delivering new and innovative solutions to exceed customer needs. He has more than 25 years of experience working with global packaging, labeling, pre-media and artwork management leaders in the pharmaceutical and medical device sectors.
Ensuring that the related risks of manual proofreading and approval processes are identified and solved quickly and easily, allowing only approved content to be printed or published.
Josephine Bergmann Paslat – Product Owner Patient Solution | Pharmacist Rote Liste® Service GmbH
Josephine started her career as a pharmacist in the editorial department of Rote Liste® Service GmbH over 5 years ago. Since then, she was involved in various projects focusing on structured data, including managing GI4.0® projects in the past allowing her to deepen her knowledge of ePI. Her profile is rounded off by her labelling experience in the pharmaceutical industry. Josephine studied pharmacy at Philipps University of Marburg and is a licensed pharmacist in Germany.
Carina Bachman Patient Solutions Team | Pharmacist
Rote Liste® Service GmbH
Carina has been working as a pharmacist in the editorial department of Rote Liste® Service GmbH for over 4 years. As part of the patient solutions team, she is jointly responsible for the project GI 4.0®. Through the project work and her regular participation in international and national working groups focusing on ePI, she has specialized her knowledge in this field, particularly regarding the electronic patient information leaflets. Carina has completed her studies at the University of Freiburg.
