Unpicking an SmPC
Following on from Emma Goldsmith’s webinar on EMA Templates and Terminology for Medical Translators, “Unpicking an SmPC” explains the pharmaceutical and pharmacological concepts underlying the various headings of this fundamentally important document. Although the talk is based on the EU SmPC (often referred to in the UK as the SPC!), the topics discussed – such as “What’s in a name”? “What are excipients?”, “Why are pharmacokinetics important?”, “What determines the length of a shelf-life?” – apply to similar core production information texts e.g. the US “Prescribing Information”. The talk includes examples of translation problems encountered by fellow translators.
Ever wondered what is meant by “hard gelatin capsule”, “pro-drug”, “dose-titration”, “CYP isoenzymes”, “first-pass effect”, “bioavailability”, “competitive antagonist”? Tune in and find out!
Pablo Mugüerza is a Spanish medical translator with almost 30 years of translating experience, both in-site (McGraw-Hill) and as freelance (most of the time). He received his medical degree in 1987, and since then he has worked for the most important translation agencies in Spain and abroad, and for most of major pharmaceutical companies and CROs. He is an external translator for the WHO in Geneva, Switzerland. He is one the major authorities in the translation of clinical trial protocols EN>ES, about which he has published a highly-demanded handbook. He has presented at many workshops, courses and conferences both in English and in Spanish, online and in several countries.
CIOL membership discount: 10% (the code is available on the membership page)
1 hour and 21 min.
Who should watch it?
Both new and established medical translators.
What are the benefits to you?
With this video, you will obtain a good background on this type of texts, encountered by medical translators.