CPD record of Kaspars Melkis
18 July 2017 – European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
Finished reading this extensive document because I wanted to learn more about the timeline of marketing authorisation application review by EMA, particularly when then initial translations of SmPC, Annex A and PI in national lang is due and how much time translators have for implementing updates. This document of more than 100 pages gives answers to all of this, including many more: what are application types, what role EDQM and QRD group have in the process. I still want to know how exactly the decisions about linguistic quality and appropriateness of terms are made in languages that do not have official MedRA glossary available.
2 July 2017 – adherence to PrEP effectiveness in HIV prevention
In continuation of ECHO presentation series Dr. Joanna Stekler talks about the effectiveness of PrEP (pre-exposure prophylaxis) in prevening HIV infection and how lack of adherance is related to treatment failure. This video was instructive to better understand terminology used in HIV treatment and interpret clinical trial results.
1 July 2017 – Tenofovir trials:
Tenofovir is known antiretroviral drug developed by Gilead Sciences and belonging to the class of reverse transcriptate inhibitors and used for treatment of HIV and Hepatatis B. However, it was not very clear why there are different formulations of tenofovir such as tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF). Dr. Brian Wood in this videos talks about latest studies and what advantages the newer formulations have over the previous ones when tenofovir is used as part of HAART (highly active anti-retroviral therapy) regiment. It indicates that while TDF is a pro-drug that is converted into active drug tenofovir in plasma, TAF is converted to the active drug in the target cells, thus allowing for lower plasma concentrations leading to less side-effects.
E-mail: firstname.lastname@example.org Phone: +44 753-575-3131