Tag Archives: Ph Eur 8th Edition

Have you seen what is coming?

Recent developments influencing the updating of our popular CTD Module 3 course include new legislation (the Falsified Medicines Directive), new guidance on impurities particularly in drug substances, the upcoming 8th Edition of the European Pharmacopoeia …. and more. 

At our course we anticipate keen interest in our ‘FMD explanations, consequences and updates’, and an informative, group interactive discussion on these subjects.  FMD impacts are many and apply from ‘where and how the drug substance is synthesised’ through numerous aspects of ‘dosage form manufacture, any import into the EU, and other facets of distribution, traceability and verification’ to ensure that the patient receives the intended pharmaceutical treatment.

In addition, other specific FMD questions to be addressed include:

Which Member States remain slow to transpose the FMD into national legislation?

Which countries are Equivalent Countries?

Which countries will issue Written Confirmations?  Will some countries have a number of State systems rather than a single national one?

Are contingency plans in place for certain ‘at risk’ situations in certain Member States?

More personally, are you someone who has already seen the ‘FMD train coming down the track’ probably from distant places, and wants to learn much more?  Or is this fresh news to you?

The evolving compliance issues are hugely important extending as they do from ‘active substance starting materials and the definition and acceptance thereof’ right up to the point of ‘dispensing of medicines in local pharmacies in our own communities’ …. and lots that goes between!

Rather a lot of new Quality subjects for pharmaceutical regulatory personnel and others to learn about, on top of the basics of Module 3 regulatory science!

Please hurry to book if you want to secure a place.