Nationally, within the EU and globally
- Information and deviation management
- Global labelling - dealing with national peculiarities globally
- Falsified medicines, end-to-end labelling and electronic labelling
- Improvement of the SmPC: SmPC Advisory Group update
- Improving readability of the - PL benefit-risk approach
This distinguishes our event
Aims and objectivesThis conference will give you a thorough update on labelling challenges and duties at the national, EU and global levels. Day one will address labelling and information management. You will receive practical tips on how to use CCDS and CSI in global labelling, and get the latest information on the options for label tracking and electronic labelling.
Day two will provide updates on PL and SmPC improvements, followed by a hands-on workshop on labelling management in the marketing authorisation procedure as well as in life cycle management.
After having attended this conference, you will be knowledgeable about your labelling duties for 2018 and 2019, and you will have received practical tips for your business operations at the national, EU and global levels.
Members of the following departments will particularly benefit from this conference:
- Regulatory affairs and labelling
- Medical affairs
Day 2: 09:00-17:00 conference
- Release activities
- Worldwide harmonised product information: A dream?
- CCDS and CSI to structure and to track
- A CCDS or non-CCDS strategy?
10:45 Coffee break
- Challenge: national texts and locally submitted texts
- Necessary data and processes
- Combining regulatory information management and ERP
- Impact of EMA SPOR timelines on implementation
- Importance of master data for electronic labelling
15:15 Coffee break
- Ensuring end-to-end labelling
17:00 End of day one
- Structure of the SmPC AG web page for assessors and the industry
- The updated Q&A and the most important changes
- Benefit-risk presentation in the future
10:30 Coffee break
- Iterative user testing
- Structured benefit-risk approach
- Interdependencies between labelling and the dossier
- Timely involvement of labelling specialists in dossier creation
- Common pitfalls
15:00 Coffee break
- Aspects to consider when creating new information for the CCDS and CCSI
- How to design adequate supporting rationales to maximise implementability of labelling changes
17:00 End of the conference
Director, Regulatory Intelligence, Global Regulatory Affairs
Director Labelling, Corporate Regulatory Affairs
Head Global Labeling Team 1
Global Labeling Manager
B.Sc. M.Sc. M.R.Pharm.S. Group Manager Access & Information for Medicines & Standards
Managing Director Ms Beime has managed her own consultancy business (various company names), with a focus on regulatory and medical-affairs projects, including marketing authorisation applications for medicinal products, since 2005. Her passion is labelling for medicinal products, including readability user testing. Beate has more than 20 years' experience in the pharmaceutical industry.
Nähere Informationen finden Sie hier.
Nähere Informationen finden Sie hier.
Senior Expert Pharmacovigilance, Bonn, GERMANY
External expert for URPL and EMA; Assessing of PI and User consultation reports for the Polish CHMP member; Member of SmPC Advisory Group, Warsaw, POLAND
Phone: +49 69 70730-0
Fax: +49 69 70730-333
- Discuss issues with experts from the industry and from authorities
- Focus on national, EU and global labelling challenges
- Workshop with hands-on tips for labelling in marketing authorisation procedures
It's a very interactive course, with qualified speakers
SIGMA-TAU S.p.A., Italia
Speakers with "true" operational experience balance between regualtors and industry,
sectioned schedule, that allows some flexibility of attendance
Gives a good overview of the current topics
I would recommend that course to other, because of conference contrent and the presentation
cover all broader aspekts of labelling functions (esp. EU market)
I get the information I needed!
It adresses a lot of different interesting issues int the terms of labelling
The speakers with at lot of experiences, passing them on and help uns implement this issus on our daily-basis work
Agency for Medicinal Products and Medical Devices of Rep. Slovenia
I was able to understand labeling approach of different companies.
Labeling changes, experiences from other colleagues
Stay in content with authority industry and members
Very broad information on different labelling topics incl. health authoritiy experiences
Very informative and interactive
Great speakers with a lot of experiences
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