PHARMACEUTICS

Registered nurses in Sweden have extensive responsibilities when it comes to pharmaceuticals. This requires an in-depth knowledge of drug manufacture, pharmacodynamic and pharmacokinetic properties, posology and methods of administration.

As a translator in the pharmaceutical area, I am well acquainted with the regulations and the use of templates in European Medicines Agency (EMA) documentation as well as the regulations of the Swedish Medical Products Agency (Läkemedelsverket).

Some examples of the type of content I work with in the pharmaceutical field:

– Summary of Product Characteristics (SmPC)

– Package Leaflets (PL) and labelling

– Pharmaceutical Companies’ Website Content

– Marketing Materials

– Product Specifications

– Drug Registration Documentation

– Adverse Events Reports

MEDICAL DEVICES

In our fast-moving world of technical development, medical devices and equipment is one of the most rapidly growing industries. And with Internet, the market is increasingly global.

However, it is also a strictly regulated field, and all documentation must be accurately localized and adapted according to the rules and regulations of each country and area, e.g. the EU Medical Device Regulation which is now replacing the former Medical Devices Directive.

In Sweden, the controlling authority is the Swedish Medical Products Agency (Läkemedelsverket).

Some examples of the type of content I work with in the medical devices area:

– Instructions for Use (IFU)

– User Manuals

– Website Content

– Product Specifications

– Medical Device Software

– Safety Data Sheets

– Regulatory Documents

CLINICAL TRIALS

I am curious and have always taken a great interest in research and science. Through my academical background I am well versed in scientific language and methods, and I keep myself updated on the latest development in medical research.

Clinical trials are not only about developing new drugs; they can also involve testing and evaluating medical devices, new diagnostic methods, or methods for disease prevention and non-pharmacological treatment. Another purpose may be to study new usages for an existing drug.

I work with documents related to all the stages of a clinical trial, from patient recruitment to study report. The translation of clinical trial documents requires rigorous attention to detail – each number, letter and term matters.

Some examples of the type of content I work with in the clinical trials area:

– Patient Recruitment Materials

– Informed Consent Forms (ICF) for various target/age groups

– Patient Information Materials

– Case Report Forms (CRF)

– Clinical Protocols

– Patient Reported Outcome Measures (PROM)

– Clinical Study Report (CSR)

– Academic Journal Articles

HEALTH CARE

Health care translation ranges over a wide variety of documents and texts.

General and patient-specific health information is made easily accessible and shared on the Internet, on blogs and websites. When translating this type of texts, one usually needs to pay special attention to the localization, or local adaptation, of the content, in order to make the reading worthwhile and relevant for the intended target group.   

Medical records and reports, typically containing a substantial amount of medical jargon, sometimes need to be decoded prior to translation. Other texts aimed at health care professionals may be training manuals, checklists and rating scales.

Some examples of the type of content I work with in the health care area:

– Medical and Health Records

– Medical Reports and Certificates

– Insurance Claims

– Health Information Aimed at the General Public

– Patient Information Leaflets (PIL)

– Patient Surveys and Questionnaires

– Checklists & Rating Scales

– Training Manuals for Health Professionals