At Whitehall Training we appreciate that you need to know your training reflects the most recent version of legislation possible. This is why we have a continuous programme of monitoring and updating to ensure that the course you access is as reliable and accurate as possible. Some changes reflect evolving regulation whereas others are prompted by client comments and suggestions.
In the fast-moving arena of clinical trials, you can appreciate we make a lot of changes – some relatively small and others, quite fundamental. Whatever the complexity of the update, you can be confident that the licence you hold will automatically give access to the most recent version.
We are currently amending our US GCP course to reflect the latest regulatory changes – we expect to have a new version ready in less than two weeks. We are also making some fundamental changes to the exam of the GCP adapted for Germany to make the structure and phraseology a little more German.
The following are some of the updates we have brought out over the last few months…
GMP (annex 13) – In February, we expanded coverage on several areas including quality control, labelling, and the product specification file, prompted by the publication of the MHRA’s Orange Book.
GCP Adapted for France – In January, we created a new GCP course tailored to the specific interpretation of ICH and EU GCP rules in France.
Good Distribution Practice – In December, we updated the GDP course to include a newly passed piece of US legislation governing the use of anti-counterfeit measures.
Good Clinical Laboratory Practice – In December, we launched a new course intended for laboratories involved in the clinical trials process. According to the author, Louise Handy, “possibly 80% of the data from clinical trials originates in the laboratory, but the main guidance on clinical trials (ICH-GCP) contains no information on how to conduct the laboratory activities generating that data. GCLP and the recent EMA reflection paper fill that gap and provide clear guidance for those managing and working in laboratories that handle and analyse clinical trial samples.”
All GCP courses – In November, we revised all GCP exams to make the question choice less confusing without affecting the difficulty level.
US GCP course – In September, we updated the US GCP course to reflect new FDA guidance published the previous month.
Pharmacovigilance – In August we made several changes to three of the four pharmacovigilance modules, partly to reflect revised European legislation that was finalised in July.
