Why this blog?
Pharmaceutical companies, medical device manufacturers, healthcare providers and companies from related industries such as the chemical and food industries are facing increasingly complex regulatory requirements.
This is especially true in Europe, but also in North America and Asia. Companies are heavily committed to translating a comprehensive array of documents into local languages and to publishing them. There are a multitude of national and international regulations and guidelines to be followed (e.g., REACH-CLP, MSDS, EMA templates for PILs and SPCs, etc.). Most of these regulations have a direct impact on the translations – not only do they specify the exact wording , but also, for example , U.S. guidelines on the content of consent forms for clinical trials simply do not apply in Europe, where other content guidelines take precedence.
Translation service providers who are not familiar with these guidelines run a serious risk of providing their customers with incorrect translations – this does not only lead to them losing customers, but can also mean considerable costs.
Unfortunately, many language service providers and freelancers are not familiar with these regulations and guidelines. Likewise, many clients do not know how to identify appropriate service providers and how to best cooperate with them to achieve top quality.
Whether it is a translation of a consent form for a clinical study, localization for PACS software, a corporate website or SOPs for the production of a flu vaccine – we strongly believe that any project not only requires regulatory, domain-specific and linguistic knowledge, but also close cooperation between all parties. This is just as true in medicine, where teamwork is often a necessity and where each member fulfills a specific role to achieve the best possible result.
With this blog, we intend to build a bridge between companies in GxP industries and the language and document services in order to support this team-building through mutual understanding.
The topics covered in this blog include:
• regulatory issues
• relevant standards and guidelines
• language service providers’ tools for translation and quality assurance
• procedures, the significance and application of which are often unclear (e.g. back translation, linguistic validation)
The team will be also posting industry news and writing on less serious topics – because occasionally we all need some fun!