Dora Wirth Languages | Pharmaceutical Translations https://www.dwlanguages.com Need global life science solutions? Rely on us. Problem solved. Tue, 03 Jul 2018 14:23:52 +0000 en-US hourly 1 https://wordpress.org/?v=4.9.8 DWL Expo Schedule 2018 – Part 3 – DIA 2018 Global Annual Meeting https://www.dwlanguages.com/dwl-expo-schedule-2018-dia-global-annual-meeting/ https://www.dwlanguages.com/dwl-expo-schedule-2018-dia-global-annual-meeting/#respond Wed, 20 Jun 2018 16:10:41 +0000 https://www.dwlanguages.com/?p=2364 Part 3 - DIA 2018 Global Annual Meeting DIA 2018 - Boston, USA - 24-28 June - Booth #2238 This post is part of our DWL Expo Schedule 2018 series. For the full list, click here. Nearly two months after our last conference in London, we are attending the DIA Global Annual Meeting in Boston. The conference

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Part 3 - DIA 2018 Global Annual Meeting

DIA 2018 - Boston, USA - 24-28 June - Booth #2238

This post is part of our DWL Expo Schedule 2018 series. For the full list, click here.

Nearly two months after our last conference in London, we are attending the DIA Global Annual Meeting in Boston. The conference is the largest, longest-running event in the life sciences industry. It aims to bring together stakeholders from across the world to share knowledge, facilitate collaboration and drive innovation in healthcare product development and life-cycle management globally.

The Drug Info Association (DIA) has recorded its highest Global Annual Meeting registration numbers in the last 7 years. Expected to attend are over 6,000 professionals in the pharmaceutical, biotechnology and medical device communities from over 50 countries, plus over 450 exhibitors, including DWL. Last minute registration is still possible but closes tonight, so attendance numbers can be expected to grow even more.

We are exhibiting at booth number 2238, so do drop by. We are particularly keen to talk to companies about translation services tailored to their requirements, including variations and linguistic reviews (assessing state member comments). And if that's not enough of an incentive, we are also giving away a pair of BOSE headphones to one lucky draw winner.

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DWL IS HIRING: Translation Project Manager https://www.dwlanguages.com/dwl-is-hiring-translation-project-manager/ https://www.dwlanguages.com/dwl-is-hiring-translation-project-manager/#respond Mon, 18 Jun 2018 15:01:14 +0000 https://www.dwlanguages.com/?p=2360 DWL is hiring! We are looking for an experienced Project Manager to provide extra support for a busy translation service provider specialising in the life sciences. Job description: As a Project Manager at DWL you will: Handle key accounts as part of the project management team. Manage projects in the medical / pharmaceutical field, including for

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DWL is hiring!

We are looking for an experienced Project Manager to provide extra support for a busy translation service provider specialising in the life sciences.

Job description:

As a Project Manager at DWL you will:

  • Handle key accounts as part of the project management team.
  • Manage projects in the medical / pharmaceutical field, including for submission to the European Medicines Agency (involving up to 24 languages).
  • Be responsible for quotations, order handling and quality control of the translations.
  • Operate within DWL’s quality management system and ISO 9001 certification.
  • Set up and process compatible translation projects in memoQ.
  • Be responsible for the final MS-Word processing of the translations to ensure that they respect the standard requested by the client.
  • When required, work paid overtime (evenings, occasional weekends).

Profile:

  • We are seeking a committed and dynamic person with excellent communication skills and strong knowledge of both spoken and written English and project management experience of ideally 2 years or more.
  • Languages: knowledge of at least 2 European languages other than English is essential, and some understanding of the nature of scientific publications and documents, particularly regulatory/pharmaceutical/medical documentation, is a bonus.
  • Regulatory: familiarity with EMA templates and standard terminology for this type of documentation would be ideal but is not essential.
  • Accuracy: accurate and thorough quality control is essential to ensure that all the material delivered to clients complies with DWL quality standards.
  • IT: computer literacy and strong MS-Word processing skills are essential as the project management occasionally requires the preparation/finalisation of layout/format for the translated documents. Must be experienced in working with a CAT tool (preferably memoQ)
  • Desirable: Working knowledge of a TMS, in particular Plunet.

Our ideal candidate is a flexible, positive thinker. You enjoy working in a small, busy team and are always striving to find creative solutions to customer and translator problems.

Start date:

ASAP

Working Hours:

The position is office-based, Monday to Friday 09:30-17:30.

The Office and Team:

Based in Brook Green, Hammersmith, we are a team of 12 staff. Our office is a relaxed and international environment, situated within a block of modern offices with good catering facilities including a barista, exciting social events and comfortable break-out areas.

To apply, please send your CV to info@dwlanguages.com

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DWL Expo Schedule 2018 – Part 2 – BioTrinity 2018 https://www.dwlanguages.com/dwl-expo-schedule-biotrinity-2018/ https://www.dwlanguages.com/dwl-expo-schedule-biotrinity-2018/#respond Mon, 23 Apr 2018 09:07:04 +0000 https://www.dwlanguages.com/?p=2346 Part 2 - BioTrinity 2018 London, UK – 23-25 April – Booth #32 This post is part of our DWL Expo Schedule 2018 series. For the full list, click here. Nearly a week after DIA Europe 2018 in Basel, we are attending BioTrinity 2018, held on our doorstep in Hammersmith. The event will bring together

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Part 2 - BioTrinity 2018

London, UK – 23-25 April – Booth #32

This post is part of our DWL Expo Schedule 2018 series. For the full list, click here.

Nearly a week after DIA Europe 2018 in Basel, we are attending BioTrinity 2018, held on our doorstep in Hammersmith. The event will bring together representatives from biotech, medtech and pharma, as well as consultants, investors and advisors, and members of associated industries. The aim of the conference is fostering networking and partnerships within the life sciences on a global scale.

This year’s theme is Next Generation Healthcare, which focuses on current and future innovations in healthcare. BioTrinity 2018 will feature keynote talks and panel discussions on topics including AI and drug development, nanotechnology, and next generation chemistry.

We are exhibiting at Stand 32, so drop by to speak to our team about all things translation and more.

 

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DWL Expo Schedule 2018 https://www.dwlanguages.com/dwl-expo-schedule-2018/ https://www.dwlanguages.com/dwl-expo-schedule-2018/#respond Thu, 05 Apr 2018 11:17:29 +0000 https://www.dwlanguages.com/?p=2333 DWL provide language solutions to a wide variety of life science companies, particularly relating to pharmaceutical, medical, and regulatory affairs. Our busy Hammersmith office is a hub of constant activity: our project managers work with translators, customers, and local Health Authorities to ensure prompt delivery of translations to our global customers. That said, the work

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DWL provide language solutions to a wide variety of life science companies, particularly relating to pharmaceutical, medical, and regulatory affairs. Our busy Hammersmith office is a hub of constant activity: our project managers work with translators, customers, and local Health Authorities to ensure prompt delivery of translations to our global customers.

That said, the work of a successful translation agency extends far beyond the written word. Much like our linguists, we need to stay up-to-date with industry developments, and meet new and existing customers face to face. As a result, we are regulars on the exhibition circuit, and we will be at several international events this year.

The full list is below, and we will post more information about each event closer to the time. If you are attending any of these, we would love to hear from you. Drop by our stand for a chat, or reach out on social media to let us know you're coming. We are always happy to discuss the translation services we offer, as well as regulatory procedures and industry news, and our friendly team will be sure to answer any questions you might have.

DWL 2018 Schedule:

Part 1 - DIA Europe 2018

Basel, Switzerland - 17-19 April - Booth #27

The largest European multidisciplinary event centered on innovations in medical products and therapies for patients returns for its 30th year. DIA Europe 2018 brings together life science professionals from the entire health care value chain to foster relationships and collaborate on healthcare solutions.

Held in scenic Basel, DIA Europe 2018 features 8 thought leadership streams and 9 programme topics ranging from medical devices to big data. The three-day event will be split into over 60 sessions with more than 250 speakers. DIA Europe 2018 will also feature over 110 exhibitors - including DWL - representing key industry stakeholders.

Other upcoming events:

Part 2 - BioTrinity 2018 

London, UK - 23-25 April - Booth #32

Part 3 - DIA 2018 Global Annual Meeting

Boston, USA - 24-28 June - Booth TBC

Part 4 - TOPRA Annual Symposium

Stockholm, Sweden - 1-3 October - Booth TBC

Part 5 - RAPS Regulatory Convergence

Vancouver, Canada - 1-4 October - Booth TBC

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Celebrating women in the sciences for International Women’s Day https://www.dwlanguages.com/women-scientists-iws/ https://www.dwlanguages.com/women-scientists-iws/#respond Thu, 08 Mar 2018 14:18:36 +0000 https://www.dwlanguages.com/?p=2314 Throughout human history, science has progressed via a continuous process of trial and error, and some of the greatest breakthroughs have resulted from some amount of luck (something we have written about before), near-misses, and plenty of perseverance. Many people have gone to great and often dangerous lengths in pursuit of medical knowledge. Today, figures

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Throughout human history, science has progressed via a continuous process of trial and error, and some of the greatest breakthroughs have resulted from some amount of luck (something we have written about before), near-misses, and plenty of perseverance. Many people have gone to great and often dangerous lengths in pursuit of medical knowledge. Today, figures such as Marie Curie, Rosalind Franklin and Dorothy Hodgkin are widely recognized for their contribution to the advancement of science and medicine. However, they are not alone as women in the sciences.

In celebration of International Women’s Day, we would like to bring to the fore some lesser known female innovators in fields as diverse as haematology, philanthropy and translation. How many have you heard of?

Lucy WillsThe haematologist – Lucy Wills

Lucy Wills was a pioneering English haematologist credited with the discovery of folate. After studying geology and botany at Cambridge, which at the time did not award full degrees to women, Wills enrolled at the London School of Medicine for Women in 1915. Following her studies, she developed an interest in haematology and particularly anaemia, possibly emboldened by George Minot’s research into pernicious anaemia. In 1928 Wills received a grant to travel to Bombay to research a link between macrocytic anaemia and pregnancy. Through experiments and clinical trials, Wills discovered that she could not only reverse, but also cure pernicious anaemia with Marmite. This was due to a pivotal chemical nutrient she named ‘the Wills factor’. Scientists later discovered this chemical was folate, the naturally occurring form of folic acid, which is crucial for cell division and blood production. After retirement, she continued to focus on health and nutrition in South Africa and Fiji.

The philanthropist – Mary LaskerMary Lasker

Mary Lasker (née Woodward) was an American socialite, philanthropist and health activist who successfully raised funds and public awareness for medical research, particularly around cancer. Lasker established herself as an influential businesswoman during the Great Depression by founding a successful clothing company for professional women. In 1939 she met her husband Albert Lasker, himself an innovator in the field of advertising. The two began a powerful campaign against cancer by using advertising tactics to rally support and raise funds. They set up the Lasker Foundation to promote medical research, and overhauled the American Society for the Control of Cancer, raising over $12 million in donations. Lasker’s efforts intensified after losing her husband to colon cancer. She founded the National Health Education Committee, helped expand the National Institutes of Health, and partnered with Sidney Farber, the pioneer of modern chemotherapy, to further research and gather funds for his innovations. Lasker was tireless in her efforts, and continued working until her death in 1994.

Gertrude ElionThe pharmacologist – Gertrude Elion

Gertrude Elion is an American chemist and pharmacologist who discovered Purinethol, a crucial drug for the treatment of leukaemia. Having lost her grandfather to cancer, Elion pursued a career in medicine in the hopes of finding a cure. Following a graduate programme at New York University, she worked as an analytical chemist for a food company during World War II. She later moved into a research position with Burroughs Wellcome (which later became GlaxoSmithKline). Here she expanded her knowledge in biochemistry, immunology, pharmacology, and virology. In collaboration with biochemist George Hitchens, Elion began comparing pathogens with normal human cells to develop drugs that would kill the former without harming the latter. She developed drugs including 6-mercaptopurine (used to treat leukaemia, crohns disease and ulcerative colitis), azathioprine (an immunosuppressant), pyrimethamine (originally used as a cure for malaria), and acyclovir (for viral herpes), amongst many others. For her outstanding achievements, Elion was awarded the Nobel Prize for Medicine in 1988.

The virologist – Francoise Barré-SinoussiFrancoise Barre-Sinoussi

Francoise Barré-Sinoussi is a French scientist who first identified HIV as the cause of acquired immunodeficiency syndrome (AIDS). Unsure whether she wanted to pursue a scientific career, she joined the Pasteur institute in the early 1970s on a part-time basis, but soon became full time. During this period, Barré-Sinoussi developed an interest in retroviruses in time for the AIDS crisis of the 1980s. Her discovery in 1983 that HIV causes AIDS had profound ramifications on public understanding and perception of the disease. Barré-Sinoussi continued her research into retroviruses, and made important contributions to understanding adaptive immunity, viral infections, and mother-to-child HIV transmission. In 2008, in collaboration with Luc Montaigner, she discovered that HIV attacks lymphocytes, which are vital for the body’s immune system, a breakthrough for which she was awarded the Nobel Prize in Physiology or Medicine.

The linguist – Dora Wirth

Dora WirthOf course, we are also celebrating the achievements of Dora Wirth, founder of Dora Wirth Languages Limited. She was a remarkable linguist and businesswoman. A Russian native, Dora and her family emigrated to Warsaw after the Counter Revolution of 1919, before settling in Danzig until the late thirties. In 1935 she moved to England having already become proficient in Russian, French, German, Polish and English. Her multilingualism earned her a job at the Daily Express under Lord Beaverbrook, a minister in Winston Churchill’s War Cabinet. Dora’s efforts intensified during the war, and she helped gauge the political mood by monitoring speeches by Hitler and Stalin. After the war, and following her husband’s death in 1961, she established her own translation agency called Eurolink Limited. In 1964 the agency then became Dora Wirth Languages Limited as we know it today. Dora was an innovator in many respects, harnessing her linguistic skills to build a successful translation business, and fostering enduring professional relationships with translators, clients and her own staff. This is a tradition we celebrate and carry on today.

This list is by no means comprehensive, and medicine has benefited from the contributions of numerous women working tirelessly to advance scientific knowledge. However, since International Women’s Day is a celebration of all women from all walks of life, we asked our colleagues here at DWL about women they admire. This is what they said:

Marie:

“Audrey Hepburn was the epitome of glamour and grace, but more than that, she used her fame for the good of others, becoming an ambassador for UNICEF and visiting places of suffering to raise awareness and bring relief. She could have sat back and enjoyed her fame, but instead she fought to make other people’s lives better.”

Bea:

“Rosalind Franklin (1920- 1958), a molecular biologist who made a crucial contribution to the discovery of the DNA structure. I admire her tenacity to follow her purpose as a scientist in those years when women were not welcome in science at all. As an illustration, she became a scientist against her family’s will. Also, when she was working at King’s College she had to leave the building at lunch every day because women were not allowed to use the college café.”

Barbara:

“Maria Sibylla Merian, a German-born naturalist and scientific illustrator, and one of the first scientists to study insects. I love the fact that she and her daughter travelled to South America to observe and record tropical insects!”

Clare:

“Jessica Ennis-Hill – the star of the London Olympics 2012! I admire her success story as a world-class athlete and champion with humble beginnings.”

Flavia:

“Franca Viola is the first Italian woman who refused a ‘rehabilitating marriage’ with her victimiser after suffering kidnapping and rape in 1960s’ Sicily, and successfully appealed to the law to prosecute the rapist. Her behaviour clashed with the traditional social conventions in Southern Italy and the Italian Code of Criminal Procedure of the time, which equated rape to a crime against "public morality" rather than a personal offence, and formalized the idea of a "rehabilitating marriage", stating that a rapist who married his victim would have his crime automatically extinguished.”

Craig:

“Among many famous women, I admire Jo Pavey MBE. I am inspired by her work ethic, as a successful track athlete who has also raised a family. In 2014, 10 months after giving birth to her second child, Pavey won Gold in the 10’000 metres at the European Championships to became the oldest female to win a gold medal in the history of the competition – the finish is worth a watch!”

Iain:

As a Francophile, I have always admired Simone de Beauvoir (1908-1986). Although she is often mentioned in the same breath as Jean-Paul Sartre, de Beauvoir is, in my opinion, the more fascinating of the two. She was one of the leading intellectuals and existentialists in post-war France and wrote several novels and essays, but is undoubtedly best known for her seminal feminist work The Second Sex, published in 1949. Her autobiography spanning several volumes reveals an independent-minded, spirited person who was not afraid to break convention at a time of rigid codes of behaviour, especially for women, and it is this that I admire in her.

Valeria:

“A woman I really admire is Chief (Mrs) Nike Davies-Okundaye, an award-winning textile designer and artist. She was brought up in Nigeria amidst the traditional techniques of cloth-weaving, adire-making and indigo-dyeing but, finding that the traditional methods that had always been her source of inspiration were dying out, she decided to build four art centres offering free courses for young disadvantaged women, with the aim of teaching them about traditional arts and crafts and helping them to understand the business of art and how to manage their resources. Despite her humble beginnings, four decades later she is widely acknowledged as having trained and helped thousands of women and has had her work displayed at major international exhibitions, allowing the rest of the world to learn more about her culture through her art. Having met her personally, I can confirm she is one of the humblest and kindest people I have ever met. Today, she is the owner of the largest art gallery in West Africa and continues to be an inspiration to many.”

Sonia:

“Emilia Clarke is an English Actress born in London, but raised in Berkshire. Most people would know her from Game of Thrones or Me Before You (an adaption of the bestselling book written by Jojo Moyes). I admire Emilia not only for being an excellent actress, having a jolly and uplifting character, but also because she partakes in events to help fight for gender equality – a subject that never seems to lose its trend."

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The Landscape for CROs post Brexit: An Update https://www.dwlanguages.com/cros-post-brexit/ https://www.dwlanguages.com/cros-post-brexit/#respond Thu, 22 Feb 2018 13:33:50 +0000 https://www.dwlanguages.com/?p=2303 UK still a key player The Clinical & Contract Research Association (CCRA) held a one-day session entitled The Landscape for CROs post Brexit—An Update on 31 January 2018 at the Royal Society of Medicine in London, one year on from a similar event in January 2017. The session was chaired by Dr Virginia Acha, Executive

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UK still a key player

The Clinical & Contract Research Association (CCRA) held a one-day session entitled The Landscape for CROs post Brexit—An Update on 31 January 2018 at the Royal Society of Medicine in London, one year on from a similar event in January 2017. The session was chaired by Dr Virginia Acha, Executive Director, Global Regulatory Policy, MSD. While some of the passions surrounding Brexit may have calmed over the past year, there still remains much of the uncertainty about what Brexit means for the clinical research sector in the UK.

Throughout the day, the speakers emphasised the country's role in clinical research. For instance, 70% of EU investigational medicinal products (IMPs) are released from the UK; there are currently 1500 ongoing EU clinical trials sponsored by the UK; 1300 authorised EU products have been tested and released from the UK.

Thus, maintaining UK expertise and influence in life sciences and clinical research outside a large trading bloc is an important aim post-Brexit.

Brexit at a cost for life sciences

One uncertainty after the UK leaves the EU concerns the regulatory framework for clinical trials. A stand-alone UK regulatory model post-Brexit would mean an additional regulatory burden, which would increase costs. Negotiating mutual recognition with the EU would also take a lot of time. It is also important to maintain pharmacovigilance cooperation: if the UK is unable to access centralised databases, patients might suffer.

Safeguarding key interests

Dr John Poland, consultant to the Association of Clinical Research Organisations (ACRO), outlined what ACRO believes the UK needs to do, such as securing long-term, predictable access to funding and international collaboration for scientific research and improving tax benefits and intellectual property protection to encourage clinical research in the UK. Finally, the UK needs to establish a more collaborative environment between the NHS and industry. This would help support innovative product use in the clinical trial setting and modernise the clinical research process.

Dr Poland highlighted the need to ensure an unhindered product supply chain, since about 40% of IMPs in clinical trials being run in the EU are made in the UK. Additional requirements and/or costs to export IMPs to the EU will mean manufacturing capacity will transfer to EU countries. Dr Poland also emphasised the need for an unrestricted flow of personal data. When the Clinical Trial Regulation comes into application, there will be a single submission for clinical trials in the EU via a portal. If the UK is unable to participate in these new processes (and the date for the clinical trial portal becoming operational is believed to be the second half of 2019), it will become a less appealing place for clinical trials in Europe.

CROs preparing for the divorce

Dr Ben Quarterly, Executive Director, Global Clinical Development at Covance outlined the perspective of a global clinical research organisation (CRO) on Brexit. He explained Covance is monitoring developing thinking in London, Brussels and elsewhere and has an internal Brexit taskforce with defined roles and responsibilities. Experts need to analyse the potential impacts of Brexit, while CROs need to be ready to capitalise, prepare, engage and inform regarding the whole process. He pointed out potential opportunities: Brexit may allow a faster path for starting clinical trials and enable leverage of the overall benefits of the UK. There is already a positive focus on life sciences, research and innovation in the UK and the government is motivated to support access to international talent and to develop young people through the sciences.

Dr Lincoln Tsang, a partner at Arnold & Porter Kaye Scholer LLP, took us through the minefield of the legal landscape and the consequences of "no deal" and stressed the complexity of disentanglement from the EU and that Britain’s future relationship with the EU is still very much guesswork. Annabelle Malins, from the Department of International Trade, emphasised the importance of providing certainty and continuity to UK business post-Brexit. To do this, all negotiation outcomes need to be taken into consideration.

Unanswered questions

The day ended with a panel discussion reviewing the various issues raised during the meeting. A practical problem arising from the questions concerns the shipment of clinical trial supplies (which are often time- and temperature-sensitive) from EU countries to the USA. These issues often include hold-ups at customs. When the UK leaves the Union, will there be similar problems? Will these put patients at risk, especially if they cannot access their treatment straight away due to customs delays? Another potential problem is tariff imposition: will this lead to loss of investor confidence in the UK life sciences field?

In other words, when it comes to Brexit, there are still more questions than answers.

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Spotlight on Cuba: How fostering business partnerships with Cuba could benefit the UK and global health industries https://www.dwlanguages.com/spotlight-on-cuba-business/ https://www.dwlanguages.com/spotlight-on-cuba-business/#respond Thu, 15 Feb 2018 11:28:24 +0000 https://www.dwlanguages.com/?p=2294 Recently, DWL met with a delegation from the Life Sciences sector in Cuba, as part of an initiative by the UK Department of International Trade. At the meeting were representatives from the Cuban Chamber of Commerce and other governmental bodies, as well as pharmaceutical and biotechnology agencies including BioCubaFarma, CECMED, CIGB and CIM-CIMAB. The aim

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Recently, DWL met with a delegation from the Life Sciences sector in Cuba, as part of an initiative by the UK Department of International Trade. At the meeting were representatives from the Cuban Chamber of Commerce and other governmental bodies, as well as pharmaceutical and biotechnology agencies including BioCubaFarma, CECMED, CIGB and CIM-CIMAB.

The aim was to discuss developments and opportunities in the Cuban health markets. Delegates identified potential avenues for regional and international partnerships that would promote Cuban advancements in human, animal and plant health which could be of global benefit.

Cuba’s pharma success story

Despite the decades-long US embargo, Cuba is at the forefront of innovation and quality in the pharmaceutical and biotechnology industries. This is partly due to Castro’s encouraging scientific research through state measures and investment to counter the effects of the blockade. Today these measures include increasing inward investment in healthcare, and the work of BioCubaFarma, which coordinates the activities of several pharmaceutical institutions.

The result is that Cuba has an excellent public health service despite being a developing country with low average income. It is also the first country to eliminate mother-to-child HIV.

Cuba claims also to be a world leader in recombinant vaccines, with promising drug research in oncology and scar repair. Crucially, its researchers are actively involved in every stage of drug development.

Finally, their business models favour national collaboration instead of individual competition. What this entails is greater consistency and fewer barriers from research through to authorisation.

Why Cuba is ripe for business

Cuban decision-makers are keen to capitalize on their country’s position in healthcare by providing attractive incentives for foreign investment. For example, they claim to offer foreign investors in Cuban life sciences tax free dividends for the first 10 years. They are also claiming to offer marketing rights to foreign companies in exchange for funding clinical trials – at present Cuba is running 23 such trials in 35 countries.

Although its industry is state-owned, Cuba is open to private investment. CIM have created CIMAB SA to act like a private company in order to accept funding, develop IP “out-licenses” and pursue joint ventures outside the country. For instance, Cuba runs joint marketing ventures on monoclonal antibodies with China, Thailand and Singapore. It also has good working relationships with Russia and India, providing further possible avenues for joint research and collaboration.

Local challenges 

There are however certain challenges to overcome in light of future alliances. For instance, Cuba has poor IT infrastructure, with virtually no broadband internet access and few Wi-Fi hotspots. The use of mobile phones is limited, with no mobile Internet access as of yet. Moreover, Cuba is a cash market and credit cards are not prevalent among the population. They do accept credit cards as long as they are not issued by an American bank (Sonegate Bank and Banco Popular de Puerto Rico being the only notable exceptions).

Another challenge facing life science companies and investors interested in Cuba is the language barrier. Decision-makers claim communication can be slow and fraught with misunderstanding when working with developing nations.

Global solutions and rewards

One possible solution to the language barrier is bilingual facilitation by a language service provider such as DWL. Given our expertise in medical, pharmaceutical and regulatory documentation, we welcome opportunities to facilitate understanding for agencies and governmental bodies seeking partnerships with Cuban stakeholders.

Despite its infrastructure issues, Cuba relies heavily on open source software. This means there are low barriers to entry to the health market provided that services are free to patients. There are also considerable opportunities for companies who can turn raw patient data into health technology, with important implications for big data sectors.

The rewards for partnering with Cuba in the pharmaceutical and biotechnology sectors appear to be considerable. Foreign investment will bring much-needed drugs to broader markets, improve infrastructure and facilities, create jobs and stimulate further research. Cuba can also serve as a gateway into Latin America for drug companies and investors in the UK and worldwide, meaning access to new markets and new development opportunities.

Lastly, it is highly possible Brexit might reduce the UK's access to European markets. It is thus vital that the UK secures trade partnerships with other key markets to foster innovation and support its economy. With a first-class reputation in Life Sciences and an openness to trade, Cuba looks promising.

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EMA Human Medicines Highlights 2017 Out Now https://www.dwlanguages.com/ema-publishes-highlights-2017/ https://www.dwlanguages.com/ema-publishes-highlights-2017/#respond Fri, 26 Jan 2018 12:30:17 +0000 https://www.dwlanguages.com/?p=2275 The European Medicines Agency (EMA) has published its yearly overview of key recommendations for 2017, covering the authorisation of new medicines and related safety monitoring. The overview reveals the EMA recommended 92 medicines for approval. Of these, 35 contained new active substances never before authorized in the European Union. Most of these medicines are aimed

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The European Medicines Agency (EMA) has published its yearly overview of key recommendations for 2017, covering the authorisation of new medicines and related safety monitoring.

The overview reveals the EMA recommended 92 medicines for approval. Of these, 35 contained new active substances never before authorized in the European Union. Most of these medicines are aimed at the treatment of cancer and infections, although significant advancements have also been made in neurology, endocrinology and gastroenterology, including applications for Crohn’s disease patients.

With the publication of the 2017 highlights, Dora Wirth Languages (DWL) is proud to have worked on many of the featured medicines approved last year. Our work entailed translating the product information for each of the 24 languages of the EU/EEA member states, managing project delivery and ensuring compliance with EMA guidelines. DWL contributed to a number of new applications and extensions, as well as several variations for existing products.

Read the EMA summary in full here:

bit.ly/EMAHighlights17

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What Makes A Good Translation for Regulatory Submission (And How To Avoid Being Let Down) https://www.dwlanguages.com/makes-good-translation-regulatory-submission-avoid-let/ https://www.dwlanguages.com/makes-good-translation-regulatory-submission-avoid-let/#respond Tue, 31 Oct 2017 13:12:52 +0000 http://www.dwlanguages.com/?p=2048 When you’ve worked hard to build your reputation, the last thing you need is your translation service provider letting you down. Without a full understanding of what makes a good translation, selecting your provider can quite literally be a gamble - especially with any extra costs associated with delays to submissions. To take the risk

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When you’ve worked hard to build your reputation, the last thing you need is your translation service provider letting you down. Without a full understanding of what makes a good translation, selecting your provider can quite literally be a gamble - especially with any extra costs associated with delays to submissions. To take the risk out of regulatory translations, we’d like to share the most important factors in ensuring you get a good translation.

First things first - the highest-quality translations for submission to the EMA will always come from a highly qualified, experienced translator with the relevant medical and scientific knowledge. If you find yourself looking to cut costs by sourcing less experienced translators who don’t specialize in translating for the medical/pharmaceutical industry, think twice. Inaccurate and inconsistent translations will cost you far more in the long run. Any rejection of a translated PI at the last hurdle of your MA application not only reflects poorly on your reputation, but there is also the risk to patient safety to consider, should any errors slip through unnoticed. A specialist provider understands the serious implications of any errors or ambiguities, so you can have peace of mind knowing there will be a thorough and extensive quality control process in place.

Secondly, the best translations will come from providers with extensive experience in regulatory processes. All professionals involved in the translation process should have an excellent knowledge of the regulatory framework, documents and procedures. An in-depth understanding of your job means that your provider has a clear and supportive grasp of your needs and expectations, for example knowing when and how to use key terminology. They should demonstrate sound knowledge of the appropriate terminology and regulatory standard text and an awareness of the regulatory timetable and implications of out-of-scope changes to product information during variations or last-minute requests in the 5-day window.

As well as understanding the medical, scientific and regulatory standards and expectations, it is essential for your provider to have linguistic competence in both source and target languages. It really pays to check that your translators are required to translate into their mother tongue only. Translations provided by non-native speakers of the target language are likely to sound stilted, wooden and non-idiomatic, no matter how competent the linguist is. Note that the ISO translation standard 17100 imposes no requirement of using native speakers of the target language, so do check with your language service provider.

No matter how well your linguists rank on linguistic competency and knowledge of the subject matter, let’s not forget that accuracy is of the essence. This includes a faithful translation of the approved core text and consistent style that adheres to the conventions and expectations of the relevant regulatory bodies. Make sure your translation provider has robust and meaningful quality-control measures in place that aren’t relying purely on mechanical tools.

You may think it is fair to assume that all translations are fed into a machine these days, but in fact it is only careful (not universal) use of translation software that can guarantee quality and consistency, when overseen by human professionals with skill and experience in their subject matter.

Finding a service you can truly rely on will give you peace of mind for your submissions (let’s face it, they are stressful enough), making it easy to convince your procurement department of the worthwhile investment.

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BREXIT: WHAT LIES AHEAD FOR THE UK LIFE SCIENCES SECTOR? https://www.dwlanguages.com/brexit-lies-ahead-uk-life-sciences-sector/ https://www.dwlanguages.com/brexit-lies-ahead-uk-life-sciences-sector/#respond Thu, 02 Feb 2017 10:30:46 +0000 http://www.dwlanguages.com/?p=2004 BREXIT: What lies ahead for the UK Life Sciences sector? DWL has received several questions about Brexit recently from translators but there is currently little hard information we can give them. What we do know from the government is that Brexit means Brexit...but Brexit means what for the UK's life sciences sector? This was one

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BREXIT: What lies ahead for the UK Life Sciences sector?

DWL has received several questions about Brexit recently from translators but there is currently little hard information we can give them. What we do know from the government is that Brexit means Brexit...but Brexit means what for the UK's life sciences sector? This was one of the topics covered in a 2-day meeting of the Clinical & Contract Research Association (CCRA) held at the Royal Society of Medicine in London on 24 and 25 January 2017 and attended by the CEO of DWL, Samuel J. Wirth, and the Medical Director, Dr Iain Matheson.

 

Day 1 (entitled UK Clinical Research: A Professional Awareness Update) began with a talk by Matthew Speers, CEO of the Life Sciences Organisation, part of the Department for International Trade. He pointed out that the life sciences sector in the UK is very vibrant, with 220,000 employees, more than 5600 companies and a turnover of £61 billion and emphasised the need to promote the UK and to drive inward investment. Many overseas companies (especially in the US) see the UK as the natural stepping stone into Europe but this advantage has now been lost with Brexit, possibly to the benefit of Ireland or Germany. The role of the Medicines and Health Products Regulatory Agency (MHRA) will need to evolve – will it develop closer relationships with the US Food and Drug Administration (FDA) or relationships outside the EU (e.g. with Australia and New Zealand)? Questions for which there are not yet any answers... There is also uncertainty over what the US approach will be, now that Donald Trump is in the White House. Matthew Speers pointed out that the National Health Service (NHS) should be viewed as an asset, but that there might not be the necessary skills available due to the immigration policy post-Brexit. Over the two days, many speakers and delegates referred to the NHS as a "unique selling point" for the UK life sciences sector because of the availability of a huge amount of data in a single organisation.

 

Dr Martin O'Kane, Head of the Clinical Trials Unit at the MHRA, provided an update on the progress of the new EU Clinical Trials Regulation on Day 1. The need for a regulation has arisen from the failings of the Clinical Trials Directive, which has in some ways hampered research. The regulation will not become effective until the EU portal for processing clinical trial applications and the database have been audited and found to be suitable. User testing on the portal is currently taking place and will continue in 2017. The audit is scheduled for autumn this year. If the audit outcome is favourable, the EU Clinical Trials Regulation will come into effect by October 2018. It is unclear how Brexit will affect implementation in the UK. It is possible that the regulation will roll-over after any repeal act especially as the regulation contains many proposals favoured by the UK. As with all things Brexit, only time will tell...

 

A show of hands at the start of Day 2 entitled UK Clinical Research: The Landscape for CROs Post-Brexit indicated that most attendees thought that the UK would weather the Brexit storm and that it was not all doom and gloom. Professor Richard Barker, OBE, Director of the Centre for the Advancement and Sustainability of Medical Innovation, pointed out that the UK has some of the world's top clinicians, that with the fall in the pound's value the UK has become a cheaper market and that being a relatively small market the UK needs to be distinctive. The attractiveness of the UK as a place for life sciences organisations to do business needs to be promoted.

 

Professor Angus Dalgleish, Professor of Oncology at St George's Hospital, London, and an unsuccessful parliamentary candidate for UKIP in the 2015 General Election, offered a different view. He felt Brexit had led to a lot of hysteria and that it offered tremendous opportunities for the life sciences sector in the UK. He pointed out that the training of doctors had suffered because of the European Working Time Directive as it deprived them of valuable clinical experience and that the EU Clinical Trials Directive had been detrimental to clinical research in the UK, especially as it was interpreted very rigorously here and had meant some research had had to be abandoned. He reminded us that long before the Maastricht and Lisbon treaties there had been a lot of cooperation at European level, such as the European Space Agency, the European Molecular Biology Laboratory, the European Organization for Nuclear Research (CERN) and, of course, Concorde and Airbus.

 

Stephen Dorrell, Chair of the NHS Confederation and a former Secretary of State for Health in John Major's government in the 1990s, rounded off the Brexit debate. He believed that a quick, innovative and flexible approach to clinical trials was needed so that patients can benefit internationally. A nationalistic regulatory view is therefore contrary to his belief that innovations in healthcare should be implemented as widely as possible. As he sees it, an international research environment functions best and this of course requires the availability of a skilled workforce, something that is likely to be a stumbling block if a more rigorous immigration policy is enforced post-Brexit. He tempered the enthusiasm of some of the delegates about the NHS. Although it is a key national idea, in Dorrell's view, the NHS should be viewed not as a single organisation but as many smaller organisations.

 

We hope to be able to give an update on the implications of Brexit later in the year.

Brexit

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