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Head of U.S. MDA Visits Weibel in Denmark

IFC Involvement in Maritime Projects

U.S. Navy to Support Advanced Biofuels

Danish Energy Delegation at RETECH 2011

Greening the Army: New Energy Strategy

The Embassy Strengthens Relationship with FDA

International Project Contracts

Membership Update & Upcoming Events


Front page, from left: Gitte Lillelund Bech, Minister of Defense, Denmark and Leon Panette, Secretary of Defense, U.S. Copyright, R. D. Ward, Department of Defense. This page, from left: BG. Jørgen Jacobsen, Embassy of Denmark, Gitte Lillelund Bech, Minister of Defense, Denmark and Peter Taksøe-Jensen, Ambassador. Copyright, Embassy of Denmark


Newsletter

Sept/Oct 2011

On the 17th of August, I had the honor of welcoming the Danish Minister for Defense, Ms. Gitte Lillelund Bech, to the Danish Embassy in Washington. The Defense Minister traveled to Washington to meet with her American colleague, Mr. Leon Panetta, who took office as Secretary of Defense on July 1st this year. Not only was this visit a timely opportunity to discuss the future for Danish and American defense collaboration, but indeed also a clear indication of the importance that the United States attaches to its relationship with Denmark. On that note, I would like to emphasize the fact that Ms. Lillelund Bech was only the second European Defense Ministers to meet with Mr. Panetta since his July inauguration. Considering the close ties between Denmark and the United States on defense cooperation, we have focused this edition of the American-Danish Business Council newsletter on the possibilities that exist within the American defense sector for both Danish and American companies alike. With energy consumption within the Department of Defense equal to that of Portugal and continued efforts to improve military health services, it is fair to say that the American defense sector is more than just a market place for military products and services in the traditional sense. Certainly, companies within, especially, the energy and health sector should focus on the growing potential within the Department of Defense. That brings me to the Renewable Energy Technology Conference & Exhibition (RETECH) that took place on September 20-22 here in Washington, with Invest in Denmark as a proud sponsor. From Denmark, a delegation of seven companies lead by the Confederation of Danish Industry participated at RETECH, among them three members of ADBC, Cowi, Danfoss and Vestas, respectively. In relation to RETECH, the Embassy organized a seminar on greening the U.S. military and I had the pleasure of hosting a reception. Guests included the American Ambassador to Denmark, Ms. Laurie S. Fulton, and high ranking members of the Department of U.S. Defense. In the time passed since our latest newsletter, a new Danish Government has been elected. As our first ever female Prime Minister, Ms. Helle Thorning-Schmidt will lead a coalition of center-left parties, hereby marking a political shift from the former two-term liberal Government. We look forward to welcoming Ms. ThorningSchmidt and the newly appointed Ministers to Washington. It is our ambition to ensure that these visits at Ministerial level will be used to the benefit of your businesses as members of ADBC. On the membership side, I am pleased to welcome Mil-tek A/S as our newest member to the ADBC network. Finally, I encourage you to look ahead to this year’s Christmas reception at the Embassy on the 6th of December. I hope to see as many of you as possible.

// Peter Taksøe-Jensen


Copyright, Weibel Scientific


Newsletter

Sept/Oct 2011

possible to produce such advanced technology at such When the Director of the U.S. Missile Defense Agency a low cost if it was outsourcing parts of the production line to the same degree that it once used to: “It is core (MDA) Lieutenant General Patrick J. O’Reilly’s visited Denmark in connection with international missile de- to our business to develop and own the most imporfense conference in early September, his busy sched- tant components ourselves, this is the only way to seule allowed him to visit the company Weibel Scientific. cure our position as the technology leader – at extremely competitive prices.” A company whose radars could become essential to the European missile defense system.

Unmatched Technological Potential

It was with great pleasure that Defense Industrial Attaché Lieutenant Colonel Per Lyse Rasmussen was able to accompany the general to Weibel following the embassy’s successful effort to facilitate the visit. Lt. Gen. O’Reilly showed great interest in Weibel’s multi-frequency Doppler radar systems. “During my visit I got a new understanding of the advantages of the multi-frequency Doppler radars and I will definitely investigate the possibilities for closer collaboration between Weibel Scientific in Allerød and the MDA in USA further. Weibel Scientific has demonstrated that its multi-frequency Doppler radar has an unmatched technological potential and we should in the MDA definitely take advantage of what has already been developed here in Denmark.”

From left: Lt. Gen. Patrick J. O’Reilly, Director MDA, Peder R. Pedersen, President and CEO of Weibel and Lt. Col. Per Lyse Rasmussen, Assistant Defense Attaché at the Embassy of Denmark, Washington. Copyright, Weibel Scientific.

Weibel was recently awarded two contracts with the U.S. military, worth USD 47 million combined for the delivery of well over 2,000 radars. Additionally, Weibel has won contracts throughout most of the world with other customers.

Their unmatched technological potential is what makes Weibel’s multi-frequency Doppler radars stand out: According to Weibel Scientific, they are “mobile, For further information, please contact: highly accurate and have extremely long ranges. This Lt. Col. Per Lyse Rasmussen, Assistant Defense, Military, Naval and means that a Weibel radar can accurately track enemy Air Attaché / pelyra@um.dk missiles across very long distances.” Emphasizing the potential usefulness of their radars to the US-led effort to establish a missile defense system in Europe, Weibel Scientific’s CEO, Peder R. Pedersen, says: “NASA uses our technology and so does a large part of Europe’s and U.S. defense organizations. For us, being part of the future missile defense system is a natural development of our multi-frequency Doppler technology.” Unlike many other Danish companies, Weibel Scientific is not outsourcing, but actually doing the opposite. Identifying this as a key reason for the company’s success, CEO Peder R. Pedersen says that it would not be


Copyright, Department of Navy.


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Agricultural Industry Last month during his trip to the mid west states, President Obama, along with Secretary of Agriculture Tom Vilsack, took the opportunity to focus on the ongoing biofuels debate. From the American departments for Agriculture, Energy and Navy, respectively, came an initiative to further the development of advanced biofuels. This came in the shape of an “Request for Information (RFI)” calling on private companies to draw up a rapports on the conditions needed to establish the production and development of advanced hydro-carbon biofuel with “drop in” potential. Drop in potential indicates that this new fuel should be able to replace the current fossil fuels, without changes to the machinery that is the Navy’s large quantity of aircraft. The purpose of this RFI is for the government to establish programs that helps private companies break through some of the barriers preventing them from establishing an American market for advanced biofuels. On the 16th of August the three departments decided to earmark USD 510 million to promote private R&D and infrastructure within the advanced biofuels area. This is only legislatively possible because of “The Defense Production Act” from 1950, which allows the president to intervene in private business if there is a military impetus, even if it means direct government investment in private initiatives. There seems to be two main political reasons for this federal involvement. First off, security concerns. The U.S. is dependent on fossil fuels from abroad and self-sufficiency in regard to energy is a significant military concern. Secondly, and perhaps most politically poignant, is job creation. The high rate of unemployment is one of the biggest concerns for both the President and Congress alike, especially with the election coming up. This sort of initiative would create jobs in some of America’s rural states; states where the crisis has hit hard and where jobs for returning army veterans are sorely needed. The Department of Energy has already supplied grants to states like Illinois, North Carolina

Sept/Oct 2011

and Wisconsin, so that new biofuel plants could be established. These plants were also supported financially by the respective states. It is interesting to note that nowhere do environmental concerns pose as a reason for the establishment of this program.

Focus on Energy Independence It seems that a long term effort for the production of advanced biofuels with military application is due. Neither the fuel nor the production facilities to create it are yet in existence, but federal funding is to make it so. Navy secretary Mabus states that: “Energy independence is critical to the military and critical to national security. That is why the Department of Navy is partnered in the effort to create a biofuels market.” It is emphasized at several points in the bioenergy discussion that the establishment of a competitive and efficient market for bioenergy is never to contribute to raising the already record high commodity prices, and this condition also appears in the present RFI. However, nowhere is it stated how this is to be accomplished.

For further information, please contact: Steen Steensen, Minister Counselor, Food and Agriculture / steste@um.dk


Copyright, Department of Defense.


Newsletter

New Energy Strategy The Department of Defense recently released a strategy to meet its ambitious energy targets for the entire US Army. To the Department this strategy is a matter of savings, energy security and enhancing tactical security. As one of the largest single-consumers of energy, DoD has a potential to lead the way and be a central driver in the energy market.

Sept/Oct 2011

cient solutions so they will have a lot to offer in regards to the integration of improved and secure energy supplies.

With these policies, the US Defense is moving forward in becoming the driver of alternative energy and energy efficiency within the rest of the US society. Hence, clear advantages arise for Danish companies, ready to be part of the US Defense solutions. These solutions The Department of Defense, as an institution, is one of are likely to create a “spill over” effect on the rest of the emerging U.S. energy market, likely to create a the single largest consumers of fuel in the world. In windfall for the companies involved. 2010, the Department consumed nearly 5 billion gallons of petroleum in military operations, costing USD 13.2 billion. This is a 255 percent increase over 1997 For further information, please contact: prices. Costs that cannot be priced are the lives lost Anders Østervang, First Secretary, andost@um.dk protecting and moving fuel across the battlefield. In its new strategy, DoD emphasizes the importance of assessing all risks and costs when making decisions on its energy and equipment procurements. An example of this is the great risks associated with transporting fuels supplies for vehicles and generators through the battle field in large convoys. This calls for a reduction of the energy demand and ambitious efficiency measures in its operations, but also for exploring alternative fuels and sources of energy in the battle field.

Growing Interest in Public-Private-Partnerships In the report, DoD clearly signals an interest in learning from and working with other agencies and the private sector to diversify and secure fuel and energy supplies. The areas mostly prone to commercial interests have recently been summarized by the Washington-based think tank, the Pew Charitable Trust. The report (“From Barracks to the Battlefield: Clean Energy Innovation and Americas armed forces”) highlights the following three areas: vehicle efficiency (aircrafts, electric ground vehicles, ships), advanced biofuels; and energy efficiency, renewable energy technology for buildings and energy storage. Danish companies in the energy industry have a lot of relevant solutions to bring to the table. But competition is fierce: Major defence contractors like Boeing, Lockheed Martin and Raytheon are also pursuing this as a new and emerging market. Surely, Danish companies have the advantage of many decades of experience in developing and improving smart, energy effi-


- A Bureacratic Headache or an Attractive Business Opportunity?

Copyright, World Bank Group.


Newsletter

Sept/Oct 2011

370 million US dollars

record high.

In the past five years, Danish companies have won a total of 236 contracts with the World Bank for a combined value of USD 370 million. Within the European Union, this positions Denmark at a respectable 9th place alongside countries such as Austria and the Netherlands. Yet, among the Nordic countries, Denmark continues to hold a clear lead ahead of Sweden and Finland respectively.

Throughout 2011, the Danish Embassy has had a number of meetings with interested companies, who wish to learn about the possibilities of doing project work for the World Bank. And even though, Danish companies have performed well up until now, recent information from the Bank shows that there is still considerable unmet potential for Danish companies.

Thomas Djurhuus, Minister Counselor at the Danish Embassy and head of the department for development, is not surprised by the success of Danish companies: “The World Bank shares several priorities with Denmark, among other things, our continued focus on sustainable development, health and education. Hence, Danish companies offer a variety of goods and services that match specific project demands as set forth by the Bank in order to deliver and implement the best possible solutions to support the countries’ continued growth and development and to reach the For that reason, the Danish Embassy in Washington Millennium Development Goals for 2015.” and the American-Danish Business Council has decided A majority of the USD 370 million stems from projects to initiate a series of new activities to promote the potential for procurement at the World Bank. A closer on clean energy, delivery of medicine, especially to collaboration with the Confederation of Danish IndusAfrican countries, and consultant services, which are needed by the World Bank during preparation and im- try is intended to coordinate domestic and international activities that focus specifically on international plementation of new projects. project contracts with the World Bank.

Unmet Potential and New Initiatives

For members interested in learning more about the Although Public-Private Partnerships with international possibilities for procurement at the World Bank, the American-Danish Business Council offers to assist with organizations such as the World Bank seldom rank further inquiries and to facilitate contact to relevant high, when looking at priorities for most companies, representatives within the World Bank organization. there are still a number of reasons why companies could benefit from the opportunities offered by the World Bank. For further information, please contact:

Perhaps the Bank’s best kept secret is the fact that it is Ulrik Eversbusch, Executive Secretary / ulreve@um.dk one of the few international financial institutions Kasper Meldgaard Nielsen, Assistant Secretary / kameni@um.dk where lending has remained unaffected by economic booms and recessions. Thus, as the financial crisis continued to affect markets during 2010, the World Bank paid nearly USD 60 billion in loans and direct financing to projects in developing countries – to date a new


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World Bank Annual Meeting 2011 On 22-25 September 2011, Danish delegations from the Ministry of Development Cooperation, the Ministry of Finance and Denmark’s Central Bank, visited Washington, D.C. in order to participate in the Annual Meetings of the World Bank and the IMF. Focus was on the international economic outlook and on the Bank’s emphasis on jobs and growth, gender equality, and recent reforms that have made the Bank more open and transparent.

Focus on Gender Equality and Development

Sept/Oct 2011

country like India, and lastly the view of the donor – represented by Denmark. The Danish delegation met throughout the weekend with key senior staff of the World Bank as well as with bilateral and multilateral development partners. Apart from gender, focus was on the current global financial crisis and its potential impact on developing countries, as well as the critical issue of rising food prices. Moreover, important discussions where held on how to assist fragile states, including how to create jobs in North Africa and elsewhere. Finally, the Danish delegation had the opportunity to address the humanitarian crisis on the Horn of Africa.

At the Annual Meetings the World Development Report 2012 on Gender Equality and Development was presented at a well-attended seminar, where the Danish State Secretary, Mr. Ib Petersen, had the privilege of participating as a key-note speaker. Along with Mr. For further information, please contact: Petersen, Ministers and senior government represen- Thomas Djurhuus, Minister Counselor, thodju@um.dk tatives from around the world gave their perspective on gender and development issues relating to – among others – women in the Middle East and North Africa in the aftermath of the Arab Spring, Rwanda’s impressive success on gender equality performance, specific gender equality challenges in a large and heterogeneous

From left: Nalia Chowdhury, CEO Grameen Solutions, Bangladesh, John Rwangombwa, Minister of Finance, Rwanda, Ib Petersen, State Secretary of Development Coorperation, Denmark. Copyright, World Bank Group


Copyright, World Bank Group.


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Sept/Oct 2011

involvement will make up around USD 30-40 million. The Danish embassy in Washington has initiated a dia- The process for evaluation of potential projects and logue with the private sector window under the World negotiating terms and conditions on average runs for a period of 6 months, although this of course depends Bank Group, the International Finance Corporation on the concrete case. The IFC’s Infrastructure Depart(IFC). Leading officials from the Global Infrastructure Department of the IFC express clear interest in team- ment last year signed on to about 20 projects making up a total sum of close to USD 700 million. The bank ing up with Danish companies within the transportatypically requires 20%. ownership of a project. tion sector.

IFC Involvement in Maritime Projects

In a number of projects, the IFC has co-financed the building of new ships. This includes projects for off shore supply vessels, Ro-Ro vessels, handymax tankers, and barges to be used for internal waterways.

The IFC wishes to engage with Danish companies interested in maritime infrastructure projects in Asia, Africa and Latin America. The Danish embassy in Washington is in a key position to facilitate dialogues.

The IFC is also looking at infrastructure projects in relaFor further information, please contact: tion to dredging and sea ports. And earlier this year, the IFC signed on to provide long-term project financ- Henrik Juhl Madsen, Maritime Advisor / hemads@um.dk ing to develop a new container terminal within the Port of Santos to serve Sao Paulo and surrounding areas in the Brazilian metropolis. APM Terminals is a major shareholder in the project company. The financing for the Sao Paulo project will be provided at a maturity necessary for the project's completion, but unavailable in the commercial market. It will help the project company better manage the startup risk inherent in a greenfield project. The proposed IFC financing is expected to include an investment of up to USD 140 million from IFC’s own account and up to USD 535 million in the form of a B Loan. IFC's involvement will also help raise additional financing. The Sao Paulo – APM project illustrates how the IFC sees its role in creating venues for the private sector to engage in projects with a development prospect. The anticipated development impact is a strengthening of the port sector in Brazil by increasing container handling capacity, which again will help ease the existing congestion at the Port of Santos. The accompanied remediation of a site formerly used for waste disposal will benefit the Santos community and avoid further contamination of the soil and water. The Project will also create direct and indirect employment opportunities and increase revenues for the Government of Brazil through increased economic activity.

Looking to Partner with Danish Companies For most projects in the maritime sector, the bank’s


Copyright, Renewable Energy Law Blog.


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Sept/Oct 2011

ing Danish companies and American-Danish Business Council members Cowi, Danfoss, and Vestas along with the companies ABB, Grundfos, Solardrive, TK Energy, and Invest in the Faroes.

From left: Peter Taksøe-Jensen, Danish Ambassador to the U.S and Laurie S. Fulton, American Ambassador to Denmark. Copyright, Embassy of Denmark.

As part of the visit, the Danish Embassy in Washington hosted a well-attended reception on September 20. This gave the participating companies an opportunity to meet and connect with relevant U.S. business leaders and decision makers, such as Bob Simon, the Democratic Staff Director on the Senate Energy and Natural Resources Committee, and Katherine Hammack, Assistant Secretary of the Army for Installations, Energy, & the Environment.

Danish Energy Delegation meets with key U.S. Stakeholders and Leaders On September 20-22, 2011 the annual Renewable Energy Technology Conference & Exhibition, RETECH, took place in Washington, D.C. RETECH 2011 gathered government, utility, technology and finance professionals from over 50 countries, and it covered all of the cleantech industry’s key technologies, such as wind, solar, biomass, biofuels and waste energy. From Left: Anne Mette Vester, Minister, Deputy Chief of Mission, Embassy of Denmark, Bob Simon, Democratic Staff Director on the Senate Energy and Natural Resources Committee and Ulrik Eversbusch, First Secretary, Embassy. Copyright, Embassy of Denmark.

From left: Lt. Col. Per Lyse Rasmussen, Assistant Defense Attaché, Embassy of Denmark, Washington, Katrine Hammack, Assistant Secretary of the Army for Installations, Energy, & the Environment, BG. Jørgen Jacobsen, Embassy of Denmark and Kristine Kingery, Acting Director, Army Sustainability Policy. Copyright, Embassy of Denmark.

In conjunction with RETECH, the Danish Green Partnerships delegation visited Washington from September 19-23. The visit was organized by the Confederation of Danish Industry and the American Embassy in Copenhagen, both of which had representatives in the delegation. Members of the delegation also included lead-


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Sept/Oct 2011

James Goudreau, Captain (select), Director at the Navy Energy Coordination Office at the Office of the Chief of Naval Operations. Copyright, Embassy of Denmark.

Green Partnerships Delegation Attends Energy & Defense Seminar at the Danish Embassy in Washington

Administration (GSA) plan to implement this strategy and what role Danish energy companies may have in this regard. Rick Ballard, Director for Energy Strategy & On the occasion of the visit of the Green Partnerships Policy at the Office of the Deputy Assistant Secretary delegation in Washington, the Danish Embassy held a of the Army (Energy & Sustainability), represented the Army, while Captain (select) James Goudreau, Director seminar on energy efficiency in a defense context on September 22. Within the U.S. Department of Defense at the Navy Energy Coordination Office at the Office of the Chief of Naval Operations, spoke on behalf of the (DoD) there is increasing focus on the energy issue Navy. and, in particular, on solutions that can help reduce energy consumption. The DoD thus has a stated goal Bryan Steverson, Sustainability and Green Buildings that 25 percent of all energy consumed by 2025 must Program Advisor at GSA, then explained how his orbe supplied from renewable sources. The potential for ganization implements energy efficiency, before Wes energy savings is enormous, considering that the DoD Stith and Marston Smith from Clark Construction is America’s largest energy consumer, representing Group concluded the seminar, providing first-hand exabout 80% of federal sector energy consumption. perience on how a major U.S. building contractor works with the DoD. The seminar included networking opportunities as well as presentations by relevant representatives from the public and private sector. The first speaker was Tarak For further information, please contact: Shah, Special Assistant to the Assistant Secretary of Ulrik Eversbusch, Executive Secretary / ulreve@um.dk Defense for Operational Energy, who outlined the DoD’s newly released Operational Energy Strategy and provided insight into how the DoD aims to lower its energy consumption. Next, the participating Danish companies learned how the U.S. Army, the U.S. Navy, and the General Services


Copyright, Jacob Ehrbahn.


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Sept/Oct 2011

The Embassy of Denmark is aware of the unease with The U.S. and Danish regulatory policies are not only in the agency and work closely with the International Ofplace to ensure safe and efficacious medical products. fice of FDA to facilitate international collaboration on They are more than ever important components of the innovative technologies, aiming at enhancing transparlarger framework conditions needed to retain and bol- ency, clearer approval paths and generally enhance ster a medical industry, capitalize on product develop- communication between the agency and sponsor. ment, ensure economic growth and job creation.

Life Sciences & Healthcare Update

Manage Expectations and Meet Requirements The FDA Commissioner Margaret Hamburg has lately intensified public outreach promoting FDA as an innovation agency. This is an important component of the current politics and advocacy between sponsors and FDA user-fee negotiations, surely to affect revenue, research and regulatory oversight. In recent articles, for example in the Wall Street Journal Aug. 1st titled “America’s Innovation Agency: The FDA, “Hamburg reiterated points made at a Senate HELP Committee hearing. Noting FDA approved 21 new drugs so far in 2011, equaling the total for all 2010, Hamburg further wrote “we hope this signals a larger trend in industry and at the FDA.” She added that “when presented with high-quality applications that are based on strong science, we work quickly and efficiently.”

Following years of heated debate over the risk-benefit balance for drug approvals, many arguing the FDA had become too conservative and stifled innovation, present scrutiny falls within approval of medical devices. Recent statistics suggests that the average clearance and approval process for 510(k) products and PMAs has risen by 45 and 75 percent, respectively, since 2007 (3-6 months and 12-24 months). This is further complicated by the user-fee negotiations for medical devices and in vitro diagnostics, as FDA is under review and evaluation of the agency’s device approval pathway called 510(k) for lower risk devices, which cause much industry anxiety. This follows a recent Institute of Medicine report advising the agency to explore better ways to assess the safety and efficacy of medical devices, potentially ending with a sub-classification of the approval pathway.

According to FDA the review stage is the fastest and most predictable part of drug development. Referring to FDA’s failure rate analysis, Phase I has a 38% failure rate, Phase II has a 68% failure rate, and Phase III has a 45% failure rate all related to scientific issues. Regarding the FDA review there is a failure rate of 22% related to regulatory issues.

The Embassy of Denmark follows the U.S. and Danish medical industry close, including policy and framework conditions. Regular meetings between the U.S. Department of Health and Human Services (HHS), the Danish Ministry of Health and embassy staff ensure close dialogue and exchange of ideas and best practices, acknowledging the importance of the medical industry ensuring new innovative solutions to health and medical problems, as well as a broader societal and ecoHowever, Hamburg also acknowledges that medical devices raise problems, but blamed approval delays on nomic value creator. poor quality applications that require FDA reviewers to ask manufacturers for additional data not found in the U.S. an Important Science and Trade Partner for original filing.

Denmark – And Vice Versa These are important arguments for a commissioner to be making at this time. The negotiation between FDA and the drug and device industry over PDUFA and MDUFA reauthorization is ongoing, and much critique has been said about the agency’s ability to communicate, meet deadlines, and basically stay on course.

Danish exports to the United States increased to 35.6 billion DKK in 2010 which was an increase of 15% compared with 2009, and the largest industry was the medical device and pharmaceutical industry, contributing with 29% of the total export to the U.S. The export of medical device and pharmaceutical products to the US was 10.3 billion DKK in 2010, an increase of 36%


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Sept/Oct 2011

compared with 2009.

real life cases and examples followed by plenary debate with the experts. Most important the seminar offers a rare opportunity for individual face-to-face The U.S. market for medical devices is the biggest in consultations with the FDA regulators and regulatory the world, and it is a key export market for Danish medical device companies as approximately 20% of the executives. Danish exports go to the U.S., exceeding 3 billion DKK in 2010. The FDA Seminar is supported by Medicoindustrien, Medico Innovation, Danish-American Business Forum, The Trade Council of Denmark, and the AmericanFDA CDRH Seminar in Copenhagen Danish Business Council.

November 15-16, 2011 To facilitate current knowledge about regulations, health policies and agency guidance the Embassy of Denmark has teamed up with the FDA Center for Devices and Radiological Health (CDRH) and a regulatory consultancy group, Beaufort, to host a unique FDA CDRH Seminar focusing on International Regulatory IVD/Medical Device regulations. The initiative follows from increased collaboration between the FDA and the Embassy of Denmark, and the need to update Danish industry on current regulatory requirements. This is a win-win, as the seminar aims at facilitating sponsors submitting complete submissions, enabling FDA to clear or approve devices within expected deadlines. Further, U.S. FDA regulations are different to European (EMA) regulations in so far the U.S. FDA issues legislation on both safety and efficacy, whereas the European medical authorities only legislate on the safety of medical device. This constitutes an important difference for Danish medical device companies entering the U.S., as they need to consider another dimension of legislation. The FDA Seminar provides four leading official FDA CDRH staff and several advisory and industry experts, leading the industry to navigate step-by-step through the regulatory guidelines, practical steps, and strategic considerations for determining a product’s regulatory route to market in the most cost and time efficient way. Further the seminar will address key insights on new guidelines, innovation regulations, clinical development strategies, compliance and submission priorities, best practices, agency policy discussions and includes

For information on the seminar, please contact: Joakim Steen Mikkelsen, Life Sciences & Helathcare AttachĂŠ / joamik@um.dk

FDA Seminar 2011

Supported By


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Sept/Oct 2011

American-Danish Business Council would like to welcome Mil-tek A/S as our newest member to the organization.

Following a successful visit by His Royal Highness (H.R.H.) The Prince Consort of Denmark in June this year, organized by American-Danish Business Council and the Royal Danish Embassy at the company’s American headquarters in Virgina, Mil-tek has decided to join our expanding network as the company continue to promote their activities throughout the US. Founder of Mil-tek, Mr. Kristian Skannerup and CEO, Mr. Bryan Wingflied, both praised the participation by H.R.H. The Prince Consort of Denmark, which they believed has had a considerable impact on the way they are now perceived by their American business network. Progressive and impressive is probably the best way to describe how Mil-tek has grown from a small start-up company in Denmark, with a bright idea, to a global venture with operations in 27 countries.

This page and next: copyright, David Galen.

Mil-tek is one the world’s leading suppliers on waste disposal solutions. The company offers a varied selection of air-operated waste balers and compacters for recycling cardboard, plastic and paper. American-Danish Business Council will continue to assist Mil-tek in their ambitions to expand into the American market.


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Sept/Oct 2011


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Sept/Oct 2011

Copyright, Steen Evald.

The Crown Prince Couple of Denmark visits New York from October 20 – 24

Denmark currently spends approx. 9 pct. of its annual GDP on the national healthcare sector. The US spends approx. 17 pct.

From October 20 – 24, the Crown Prince and Crown Princess of Denmark will present the official promotional project “Creative and Healthy for Life” in New York. The Crown Prince Couple will participate in several activities, promoting a healthy and active lifestyle as well as sustainability in the areas of design, architecture and gastronomy.

Visit to Ground Zero and the UN

In New York, the Crown Prince Couple will visit the National September 11 Memorial and pay their respects by participating in a memorial ceremony together with the heads of state from the other Nordic countries. Furthermore, HRH the Crown Princess will meet with the Deputy Executive Director of the United Nations Population Fund, UNFPA. The Crown Princess is a Denmark - Frontrunner in Digital Care patron for the UNFPA that works to promote maternal HRH the Crown Prince will give a key note at the Con- health and safe motherhood in more than 150 develnected Health Symposium in Boston, where the top oping nations. In these developing countries, 1 out of 7 tier of Danish Health IT competences and solutions will women risk maternal death, compared to 1 in 17,800 be presented. As one of the leading countries in in Denmark. healthcare technology, Denmark offers a wide range of Design, Architecture and Gastronomy solutions within health-IT, incl. electronic health records, telemedicine, data handling, devices etc.. Stud- The renowned Danish furniture manufacturer ‘Carl ies have shown that the US healthcare system could Hansen & Son’ is to officially open a new showroom in save more than $81 bn. annually, better utilize health- Soho with the event “Danish Fusion” that will be atcare resources and improve the quality of patient care, tended by the Danish Crown Prince Couple. At the if it were to widely adopt digital healthcare solutions. event, Danish interiors, jewellery, music and food will


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merge into an American context. Original craftsmanship of classics and masterpieces will be showcased as part of an educational program for architects and interior designers. Good health begins with good food! Lead by René Redzepi, head chef of the world’s best restaurant, Noma, three Danish chefs will present the best of New Nordic Cuisine at the Union Sq. Greenmarket in New York. “New Nordic Cookout” focuses on local, sustainable ingredients, the heart of New Nordic Cuisine. The Danish chefs will present dishes created with greenmarket ingredients.

BIG opening! TRH the Crown Prince and Princess of Denmark will participate in the official opening of BIG New York (Bjarke Ingels Group) on October 21. The office is established in order to oversee the development and upcoming construction of West 57th on Manhattan and better service the growing work in North-, South-, and Latin-America. At the event, the Danish musical wonder duo the Raveonettes will perform.

Copyright, BIG.

Sept/Oct 2011

Danish open-faced sandwiches coming to New York The Danish chef Adam Aamann-Christensen, owner of the Copenhagen lunch restaurant Aamann's, is wellreputed among food critics both nationally and internationally. This October, he is creating a piece of Copenhagen in Manhattan with the opening of Aamanns/Copenhagen - the city’s first Danish restaurant and cultural center located in the TriBeCa Film Center building. The opening will be attended by the Royal Couple and Consul General Jarl Frijs-Madsen. The restaurant will offer an authentically Danish experience with a culinary focus on ‘smørrebrød’, the traditional Danish dish of select ingredients atop a slice of fresh rye bread, year-round cultural events and distinct Danish design. To find out more about the visit, go to www.royalvisitnyc.com


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Sept/Oct 2011

Invitation and Sponsorship Opportunity The Embassy is – for the sixth year running – hosting its annual Public Diplomacy event: Creative Christmas. The event draws 700+ of the most influential decisions makers in Washington and the US in general and is an ideal opportunity for an unforgettable evening of networking at the Embassy of Denmark hosted by the Ambassador in his residence. This year the event takes place on the 6th of December from 7:00pm – 9:00pm The Creative Christmas concept aims to present the best Denmark has to offer within the fields of business, art, gastronomy and culture. Over the past years we have been able to strengthen the Creative Christmas brand to such an extent that the event is mentioned in national and Danish media. Companies wishing to sponsor the Creative Christmas and join an ever growing group of partners may contact Pernille Florin Elbech at perelb@um.dk or at 202 320 0098 to discuss the sponsorship package or a personalized package for your company. For sponsoring companies this is an perfect occasion to invite your own valuable customers to the event. This year’s standard sponsorship package looks as follows: Sponsor Fee: USD 3,000 4 invitations to the event (2 guests pr. invitation) Company name on Embassy website Company name of electronic invitation Company name in printed program Company name in electronic newsletter to American Danish Business Council

Copyright, Embassy of Denmark.


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Sept/Oct 2011

The annual board meeting of the American-Danish Business Council will take place on December 6 2011 at the Embassy of Denmark in Washington, D.C.

All of our Sponsoring members are automatically members of the board as part of their membership and are thus invited to the meeting for a discussion on the year that has past and the opportunities to come.

A separate invitation will be sent out with specified information and a proposed agenda.

Sponsoring members: Lockheed Martin

Scandinavian Airlines

Bavarian Nordic

Torm

Vestas

Novo Nordisk

Biogen Idec

Raytheon

Novozymes

Weibel Scientific

Mil-tek

GN

Rupari

Terma

Leo Pharma

Pratt & Whitney

Systematic

In conjunction with the ADBC board meeting, you are cordially invited to participate in the Embassy’s 6th annual Christmas event – Creative Christmas – which is expected to gather more than 700 of the most influential decisions makers in Washington and the US in general.


Newsletter

Houston is the headquarter for newly formed DANISH AMERICAN CHAMBER OF COMMERCE SOUTHWEST. The newly formed Chamber of Commerce with the mission of promoting trade and good-will between Denmark and U.S. will operate primarily in the Southwestern part of the USA .

Sept/Oct 2011

Holliday, Founding Chair, Robin Ann Johansen, Founding Vice Chair, Founding Secretary Thomas Damsgaard and Founding Treasurer Sten Svendsen.

Danish Ambassador to join first official event

The first official event of the Danish American Commerce Southwest will be a luncheon meeting with DanThe Chamber will be a resource and a forum for exish Ambassador to the United States of America, Peter change of information and networking for companies Taksoe-Jensen as keynote speaker. The luncheon will doing business in both Denmark and the US. Houston be held on Tuesday, October 18th at the Hilton Ameriis home to a number of companies that are either subcas Hotel, Skyline Ballroom, 1600 Lamar Street. sidiaries of large Danish companies or independent companies with Danish roots. Among the founding members of the Danish American Chamber Southwest For more information including membership, please visit our are such well known names as: website: www.daccsw.org

Maersk Oil and Gas, Grundfos, Haldor Topsoe, Hempel USA, Vestas Technologies, Scandic Foods and Nordana Line along with Ocean Projects and Danish Inspirations. The founding Board of Directors are: Anna Thomsen

Copyright, Temporary Housing Blog.


Newsletter

Sept/Oct 2011

October 10-12:

Association of the United States Army Conference and Exhibition (AUSA) In connection with the annual Association of the United States Army Conference and Exhibition (AUSA) during 10-12 October 2011 we will have the pleasure of the company of Major General Agner Rokos, Commander Army Operational Command, Denmark. The general will be spending time on the exhibit floor at AUSA. For the first time at AUSA, Danish companies will participate with a joint Danish pavilion.

October 18:

The Ambassador visits new Chamber of Commerce in Houston

October 18:

Bjarke Ingels from BIG speaks at National Building Museum in Washington

October 20-24:

Royal visit New York TRH the Crown Prince and Crown Princess of Denmark Present Danish Healthcare, Architecture and Gastronomy in New York.

October 27:

Concert at the Danish Embassy The band Suspicious Package will perform at the Danish embassy. Besides great music, this event will also feature Danish cooking by the renowned chef, Trine Hahnemann and sponsored by Danish Crown.

October 27:

Upcoming meeting in the maritime network Members of the maritime network will meet at the embassy to discuss issues of common interest, including a presentation of the economic outlook and a session on relevant shipping policy issues.

November 15-16: FDA seminar in Copenhagen December 6:

Board meeting ADBC

December 6:

Creative Christmas 700+ of the most influential decisions makers in Washington and the US in general are expected to participate at the Embassy of Denmark for our annual Christmas event.


Sponsoring Members

Corporate Members

Associate Members Beaufort Advisors

COWI

AmCham Denmark

Danish-American Business Forum

Danish-American Chamber of Commerce, Midtwest

Danish-American Chamber of Commerce, New York

Danish-American Chamber of Commerce, Northern Carolina

Danish-American Chamber of Commerce, South East USA

Danish-American Chamber of Commerce, Southern Carolina-

Danish Information Systems Professionals

Northwest Danish Foundation


The American-Danish Business Council promotes Danish companies in the US, and American companies in Denmark. It is engaged in a range of activities aiming at obtaining an even more thriving American-Danish market place with increased trade and investment. The Council has 40 Danish and American companies and organizations as members. A number of sector-specific committees are being formed, including on Health & Life Science, Defense, Finance, Maritime, Food & Agriculture and Energy. By using the Danish Embassy's contacts and access to American as well as to Danish Authorities, the committees work to enhance business opportunities and to create network synergies and corporation. To read about membership benefits, please visit our homepage, www.usadk.org, or contact Kasper Meldgaard Nielsen, kameni@um.dk


ADBC Newsletter September/October 2011