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Within a very short deadline paper submissions will no longer be accepted by the Danish Medicines Agency. All applications must be in eCTD format as of 1 October 2019. By Susanne Felumb Paper-based submissions will [...]
Good news on search tips. Are you challenged when searching for specific information on the European Medicines Agency’s (EMA) website? You are not alone. By Lotte Gam Kristensen and Julie Lilholm The EMA website has [...]
Regulatory submissions in eCTD format - a challenge for many companies By Susanne Felumb Paper-free submissions are actually good news. Switching from paper to eCTD format will be an advantage for your company when it comes [...]
Updated guidelines on the promotion of medicinal products The Danish guidelines on company responsibility for employee activities on social media have been updated to be more specific and a comprehensive list of questions and answers has been added [...]
Well-documented knowledge is a core driver for PharmAdvice. It enables us to provide high-quality service and professional advice to our customers We have strengthened our knowledge regarding promotion of medicinal products and are pleased to announce that Susanne [...]
New safety advice for excipients demands improved labelling information The European Medicines Agency (EMA) and the European Commission have updated the annex to the European Commission’s guideline on ’Excipients in the label and package leaflet of medicinal products [...]
The new Risk Management Plan format – a major improvement for generic and well-established products By Ea Dige On 30 March 2017 EMA published Revision 2 of the guidance on the format for RMPs with major revisions [...]
New Danish guidelines include company responsibility for employee activities on the social media According to an updated version of Danish guidelines on digital medias for promotion of medicinal products, companies may now be held responsible for their employees’ [...]
Extended resources strengthen our team of Regulatory Affairs professionals We are pleased to announce that Sonja Horsted, MSc. Pharm, has joined the Regulatory Affairs team at PharmAdvice on June 1, 2017. Sonja has more than 25 years of [...]
How to ensure good practices for documentation of safety variations By Ea Dige Ensuring good practices for documentation and management of safety variations, starts by optimizing the cooperation between your Regulatory Affairs (RA) and Pharmacovigilance (PV) functions. [...]
