Training
<h2>PHARMACOVIGILANCE TRAINING</h2>
<br />Elliot Brown provides on-site training for drug safety personnel. Courses can be tailored for specific requirements, but can include:<br /><br />
<ul>
<li>Pharmacovigilance definitions</li>
<li>Limitations of clinical trials for safety</li>
<li>Signal detection and evaluation</li>
<li>Causality assessment</li>
<li>International regulations</li>
<li>Periodic safety update reports</li>
<li>CIOMS and ICH guidelines</li>
<li>The EU Clinical Trials Directive</li>
<li>Basic pharmacoepidemiology</li>
</ul>
Courses start at as little as £300 per day per person for on-site training.<br />
<h2>MedDRA® TRAINING</h2>
Training is carried out by Dr Elliot Brown, one of the creators of MedDRA. Dr Brown was a member of the MCA (now MHRA) International MedDRA Working Group, represented the EU on the ICH M1 Expert Working Group and was a founding member of the CIOMS Working group on Standardised MedDRA Queries. He has written most of the published works on MedDRA available in the scientific literature. On-site courses start at as little as £200 per person for a day's training.<br />
<h3>Basic MedDRA® Course</h3>
Intended as an introduction to MedDRA® for data management, drug safety and clinical research personnel, this course includes the development of MedDRA, the maintenance organisation, terminology scope and structure, rules and conventions, browsers and autoencoders and provides hands on coding examples and exercises.<br /><br />The 1 day course is provided on site or at an agreed venue and is normally offered for up to 15 trainees, although larger groups can also be trained. Further details are available on request.<br />
<h3>MedDRA® Coding course</h3>
A 1 or 2 day course for coding specialists. Includes introduction to MedDRA, extensive hands-on coding practice with varying degrees of complexity, Points to Consider term selection guidelines with exercises.<br />
<h3>Pharmacovigilance and MedDRA® course</h3>
A 1 day course for everyone involved in pharmacovigilance and data analysis. Includes an introduction to MedDRA, database search strategies, Standardised MedDRA Queries, MedDRA and signal detection, labelling issues, MedDRA and PSURs, version control, clinical trial safety analyses.
