Package Insert 38
Interesting facts and figures for customers and partners of mt-g.
September 2016
mt-g's fields of expertise
Pharma teams – the process
Most medicinal products take more than a decade to go from an idea at the R&D stage to market launch. A time which brings the reassurance and certainty that medicinal products taken by the consumer can be used safely. This safety can be guaranteed only if all of the authorisation-related approvals and specifications required by the authorities are satisfied. Extensive documentation has to be generated and managed in order to fulfil these requirements. This lengthy process, which involves various specialist areas and therefore places a large number of different demands on the relevant parties, can be covered in full by mt-g.

Our Clinical Studies, Global Regulatory Affairs and Pharmaceutical & Medical Communication specialist teams translate all the documentation which arises in the relevant fields of expertise and utilise the relevant translation experts. The teams work hand in hand across the entire product life-cycle so that our contacts have the relevant information at all times and are able to plan ahead for the next steps. The three teams are responsible for different stages in a medicinal product's life-cycle but never lose sight of the overall picture as it is at a given time.

In the Clinical Studies team, we receive documents which are needed well before the authorisation projects start. The preclinical phase mainly involves the processing of documents which arise before the actual clinical study. They may be patent applications or research documentation for preclinical studies. The foundations laid at this point give the applicant or marketing authorisation holder a starting point for the work on clinical studies that follows later in regulatory affairs. Our employees encounter a wide range of text types that need to be translated. The technical translators process SAE* reports, inspection reports or correspondence with the higher federal authorities just as carefully as ICFs**, study protocols and synopses. The responsibility that weighs on the translator's shoulders is extremely heavy. In this area, it is a matter not just of translating swiftly in order to meet preset deadlines but also of using subject-specific wording and, in so doing, reflecting the content accurately. After all, the data gathered here will later furnish proof of the quality, efficacy and safety of the medicinal product and thus serve as the basis for the other officially mandated processes that follow clinical studies.

Once all the study phases have been completed, the next step is the translation of the product information (SmPC, label, PIL) into up to 24 EU languages, and in several cycles to boot. This stage is extremely complex, not least because of the different authorisation procedures (DCP, MRP, national and centralised procedures), whose backgrounds, requirements and necessities must be familiar to every member of the Global Regulatory Affairs team. Particular attention is paid to ensuring that each member of the team knows the processes of the relevant procedure and has internalised their specifications. This area requires the expertise of our employees: only due to the high level of in-house subject knowledge can mt-g assist in this organisationally demanding and structurally not very transparent phase. It is not least the teamwork by the trio of the project manager, who possesses deep specialisation, the Internal Quality Assurance employee and the translator which ensures the success of these projects because the regulatory requirements and time constraints in the authorisation process are extremely strict. It therefore comes as a relief to the applicant or marketing authorisation holder to be able to rely on a skilled and capable partner in stressful times.

The nerve-wracking authorisation procedure is followed by a brief lull and the certainty of having achieved the goal: the medicinal product can be brought to market and production goes into full swing. However, the product documentation work does not stop there. Patients and healthcare professionals want to find out more about the medicinal product from brochures and websites. Employees have to be provided with information and trained and exhibition texts have to be written. Our specialists in the Pharmaceutical & Medical Communication team are always on hand to help when the written communication about a medicinal product has to be right. Whether a home page has to be localised in several languages or brochures are to be printed, our team is glad to be of assistance and will offer skilful and reliable advice. No other area is influenced by more subjective factors than marketing translations. This is why the experience which our employees have acquired in this area pays off because they know the company’s marketing orientation and the customer’s wording. It is thanks to this experience that they are able to select the right translator for the relevant text to ensure that a medicinal product's market launch ends on a high note after all the years.

“We are proud of our employees, who do their best every day despite the high demands and critical timings in the authorisation field, providing our customers with skilful assistance throughout the entire process”, reveals Jessica Giardini, Head of Project Management Pharma. She goes on to explain: “It is important to me for us to offer our customers a service that supports them before, during and after the entire authorisation process. In this way, we can also fulfil the quality requirement to keep the terminology consistent through all the life phases of a medicinal product.”

Please do not hesitate to contact us if you would like to know more about how mt-g reflects the authorisation process in the pharmaceutical industry or if you yourself are perhaps in the process of initiating authorisation projects.

Contact:

Jessica Giardini
Head of Project Management Pharma
jessicagiardini(at)mt-g.com
Tel. +49 731 176397-41

* Serious Adverse Event
** Informed Consent Form
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