Continuous Professional Development
CPD record of Kaspars Melkis
26 October 2018 – preparing standard style guide for Latvian pharmaceutical translations
A style guide is a collection of standard rules to be followed when composing articles or translating texts in specific field. Using a style guide is part of good translation practice. Some clients provide their own style guides but not all client do. Even if the style guide is provided, it sometimes misses some important aspects might be missing. In order to improve consistency in translations I decided to write my own style guide that will be used by default. Several sources were consulted and the preliminary version is available here for download. You are welcome to send any suggestions or comments that you may have.
17 September 2018 – attending the congress of the International Pharmaceutical Federation
From 2-6 September, 2018 I participated in the congress of the International Pharmaceutical Federation (FIP) that took place in CEC, Glasgow, UK. I networked with many professionals from pharmaceutical industry, community and clinical pharmacy and academia. I also took part in several workshops offered during the congress. The most valuable workshop was provided by Theo Raynor from the University of Leeds about how to write summaries of regulatory documents meant for general public. This is an EU requirement that companies will soon be required to produce lay summaries for clinical trial results. He had done research how current texts are understood by public and he provided many guidelines how the understanding can be improved and better summarries accessible to lay persons can be written. He also provided several examples when readers can have difficulties and how to overcome them. A teaching moment was when the pictogram was shown (see below) that was used on the packaging and readers were able to think of no less that four different meanings. How many meanings can you guess?
26 September 2017 – Statistical terms. Glossary creation.
I have noticed that the statistical terms create the greatest difficulties to pharmaceutical translators. The names of different statistical tests, specific usage, such as absolute risk reduction or even seemingly similar concepts that are crucial to be distinguished in clinical studies, e.g., accuracy vs. precision or incidence vs. prevalence can be indeed quite confusion. However, this should not be the case as the Association of Latvian Statisticians have colaborated with the University of Latvia and the group headed by Andrejs Ivanovs prepared the list of statistical terms for approval. The Terminology Committee of the Latvian Academy of Sciences have approved the list and I have worked on it to convert in easily usable format for MultiTerm and Trados. It can be viewed from TM-Town marketplace as soon as it will get approved there.
10 September 2017 – terminology studies: positive and negative challenge and rechallenge
These pharmacovigilance terms are used in assessing causual link between the drug and adverse effect. They can be confusing and as far as I know there are no previous translations of them in Latvian. I choice descriptive translation to make it clear to readers what they mean but in future official terms should be adopted by Latvian scientists. C3i Solutions provide excelent resource describing them: https://www.c3isolutions.com/blog/challenges-prechallenges-dechallenges-and-rechallenges/
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.
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