On the Background, Content and Detail of Module 3 of the Common Technical Document (CTD), the ‘Quality Module’
2-3 July 2013 Royal Society of Chemistry, Burlington House, Piccadilly, London W1J 0BA, UK
Much change is happening in the pharmaceutical licensing arena and the course will reflect the latest news and requirements.
Some major new developments evolving this Spring and early Summer are connected with the Falsified Medicines Directive (FMD).
There are new rules for manufacturing, importing, placing on the market, and the wholesale distribution of medicinal products in the European Union (EU). There are new rules relating to active substances and certain excipients.
Substances for pharmaceutical use and dosage forms are affected by the FMD. Many are sourced from outside the EU, adding enormously to the need to operate with GMP and GDP procedures that are fit for purpose in EU eyes!
Compliance and verification are both going to be big challenges and will add substantially to the costs that companies, who shoulder most of FMD implementation burden, have to bear.
We aim to deliver high-quality training to help you play your part in your company’s compliance work.
Here you can access our course-booking procedure.
Place numbers are limited, they really are! So don’t delay if you want to secure your booking.
We look forward to welcoming you at the course.