lunch in honor of u.s. ambassador david...

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Inside This Issue Winter 2014 Newsletter Lunch in Honor of U.S. Ambassador David Hale The American Lebanese Chamber of Commerce hosted a lunch on November 18 at the Eau de Vie Restaurant in the Phoenicia Hotel in honor of newly appointed U.S. Ambassador to Lebanon David Hale. Also in attendance were the caretaker Minister of Industry Minister Vrej Sabounjian, the caretaker Minister of Tourism Fadi Abboud, and former Ministers Jihad Azour and Sami Haddad. Several heads of economic organizations and chambers were present, including former Minister and President of the General Union of Chambers of Commerce Adnan Kassar, Association of Banks in Lebanon Chairman Francois Bassil, President of the Union of the Chambers of Commerce, Industry and Agriculture in Lebanon and President of the Beirut and Mount Lebanon Chamber Mohammad Choucair, Union of Mediterranean Confederation of Enterprises President Jacques Sarraf, Lebanese Businessmen’s Gathering President Fouad Zmokhol, International Chamber of Commerce President Wajih al-Bizri, Syndicate of Hotel Owners President Pierre Al-Ashkar, Syndicate of Public Works and Construction Contractors President Fouad al-Khazen and Lebanese Dutch Business Association President Mohammad Sinno. American Lebanese Chamber of Commerce Chairman Salim Zeenni addressed the gathering and emphasized “the strong partnership between Lebanon and the United States,” and welcomed U.S. Ambassador David Hale back to Beirut as “an old and dear friend.” Zeenni said that Ambassador Hale is returning at a “difficult time for both the region and for Lebanon itself,” and added, “The political and security environments are unstable, and war is raging a short distance from here. Lebanon’s institutions of governance are in turmoil, and elections are alarming this coming year. The economic environment is also under stress, in several sectors. Tourism is perhaps the strongest disappointment, and the retail sector is also hurting.” Yet, he went on to explain that, “there is also good news on the economic front, and we in the private sector are determined to ensure that Lebanon’s economy flourishes again across many sectors. This is where we will continue to seek the cooperation and support of the United States, which remains Lebanon’s main trading partner. We are expecting an ever stronger partnership with you being here, adding strength and direction to Lebanon’s private sector efforts.” New Members 4 Interact 2014 FDA Updates AmCham MENA Events US Trade Fairs FDA Seminar Members News 5 8 9 10 11 13

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Page 1: Lunch in Honor of U.S. Ambassador David Haleamcham.org.lb/~amchamb/uploads/newsletters/2014_winter.pdfWinter 2014 3 He then spoke about Lebanon’s business and investment climate,

This issue is sponsored by Hilton Hotels

Inside This Issue

Winter 2014 Newsletter

Lunch in Honor of U.S. Ambassador David Hale

The American Lebanese Chamber of Commerce hosted a lunch on November 18 at the Eau de Vie Restaurant in the Phoenicia Hotel in honor of newly appointed U.S. Ambassador to Lebanon David Hale. Also in attendance were the caretaker Minister of Industry Minister Vrej Sabounjian, the caretaker Minister of Tourism Fadi Abboud, and former Ministers Jihad Azour and Sami Haddad.

Several heads of economic organizations and chambers were present, including former Minister and President of the General Union of Chambers of Commerce Adnan Kassar, Association of Banks in Lebanon Chairman Francois Bassil, President of the Union of the Chambers of Commerce, Industry and Agriculture in Lebanon and President of the Beirut and Mount Lebanon Chamber Mohammad Choucair, Union of Mediterranean Confederation of Enterprises President Jacques Sarraf, Lebanese Businessmen’s Gathering President Fouad Zmokhol,

International Chamber of Commerce President Wajih al-Bizri, Syndicate of Hotel Owners President Pierre Al-Ashkar, Syndicate of Public Works and Construction Contractors President Fouad al-Khazen and Lebanese Dutch Business Association President Mohammad Sinno.

American Lebanese Chamber of Commerce Chairman Salim Zeenni addressed the gathering and emphasized “the strong partnership between Lebanon and the United States,” and welcomed U.S. Ambassador David Hale back to Beirut as “an old and dear friend.” Zeenni said that Ambassador Hale is returning at a “difficult time for both the region and for Lebanon itself,” and added, “The political and security environments are unstable, and war is raging a short distance from here. Lebanon’s institutions of governance are in turmoil, and elections are alarming this coming year. The economic environment is also under stress, in several sectors. Tourism is perhaps the strongest disappointment, and the retail sector is also hurting.”

Yet, he went on to explain that, “there is also good news on the economic front, and we in the private sector are determined to ensure that Lebanon’s economy flourishes again across many sectors. This is where we will continue to seek the cooperation and support of the United States, which remains Lebanon’s main trading partner. We are expecting an ever stronger partnership with you being here, adding strength and direction to Lebanon’s private sector efforts.”

New Members4

Interact 2014

FDA Updates

AmCham MENA Events

US Trade Fairs

FDA Seminar

Members News5

8910

1113

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“The oil and gas sector is a hot topic at the moment and needs immediate attention,” he argued. “American private sector expertise is already at work and getting involved in these ‘underwater resources’ that everyone wants a piece of. We look forward to U.S. involvement in this huge initiative to make sure that the sector will bring the benefits it promises to Lebanon’s people.”

Furthermore, he added that, “Lebanon continues to be a leader in several fields around the world. The information technology sector is booming, with the production of multi-lingual software that has been successful throughout the Arab world and beyond, even in the United States. The fashion contributions of Lebanon’s renowned designers are famous in the halls of high fashion in New York and around the world.

Agro-industry is another arena in which U.S.-Lebanon partnership flourishes. The Chamber and the Embassy have worked together over the years to highlight the potential of this sector. Our two exhibitions – “Made in America” and “Taste of America” – have been very successful in raising awareness of American brands among Lebanese consumers. Franchising is also familiarizing buyers with many of these products, creating opportunities for growth in imports of consumer products from the U.S.” Zeenni asserted that “Lebanon is also ready to increase its exports to the United States, with wine rising as a model in this respect since many Lebanese producers are already exporting their production to the United States. Lebanese winemaking is the perfect example of a sector with a latent opportunity for growth, and Lebanese wines can enjoy a greater presence in U.S. markets.”

In conclusion, Zeenni assured everyone that, “We have a lot to look forward to despite the tough circumstances. The American Lebanese Chamber of Commerce is looking forward to a partnership between Lebanon’s private sector and the U.S. Embassy in order to contribute to economic growth. The Chamber takes pride in its long-standing and successful cooperation with the U.S. Embassy, which has contributed to a great extent to improving commercial relations and business connections between the two countries, and is looking forward to continuing this cooperation.”

Ambassador Hale then took the floor, praising the efforts made by the Chamber to promote commercial exchanges between Lebanon and the United States and saying, “The American Lebanese Chamber of Commerce is a key element in the American-Lebanese relationship… After all, it is the personal ties and shared values between individual Americans and individual Lebanese, and among individual Americans of Lebanese origin, that bind our countries. These ties are reflected in so many different aspects of our two nations’ experiences.”

Hale praised the Lebanese people saying that, “This entrepreneurial spirit continues to bind our countries. For several years running the United States has been Lebanon’s number one trading partner. I applaud all those here representing companies that generate trade with the U.S.”

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He then spoke about Lebanon’s business and investment climate, noting that, “You don’t need me to tell you that greater stability will improve the investment climate and economy of Lebanon. Nor do you need me to tell you that stability alone is not enough. It was disconcerting to see that Lebanon – a country with such a strong history of commerce – placed 111th in the World Bank’s Doing Business report for 2014. Lebanon fell six places this year. Reversing this trend will require removing obstacles to investment. These include current policies on intellectual property rights, the high costs of production, and inadequate infrastructure. As your partners, we can offer programs that can assist in removing some of these obstacles. Effective, persistent lobbying by AmCham can bring results, and I would be happy to join with you in a strategy to work with your leaders to tear down obstacles to trade and investment.

He concluded by saying that, “The United States is a fully committed partner for Lebanon. We want Lebanon to be stable, prosperous, and apart from the conflict in Syria. Whether in business, education or security – in all of the many layers and dimensions of our relationship – we know what is possible when American and Lebanese individuals and their institutions work together, based on shared values, to the benefit of both our societies.”

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New Members

BK Investments is a wealth management boutique which capitalizes on the skills of its partners who bring 13 years of knowledge and experience in trading financial instruments (futures & options in multiple asset classes). Multiple asset classes are emotional enough to provide opportunities for the disciplined investor, therefore BK Investments has developed its own proprietary active trading rules based on event driven, momentum/quant, technical breakouts and mean reversion strategies. Over the years, these rules have delivered positive alpha returns while controlling risk.

Akram AdibManaging PartnersB.K InvestmentsTel: +961 1 970840

Rashid AdibManaging PartnersB.K InvestmentsTel: +961 1 970840

Sami FahedPresidentFahed Group (Holding) SALTel: +961 1 694205/6/7www.fahedgroupholding.com

Fahed Group (Holding) SAL holds a major interest in several companies operating in Lebanon, mainly in the retail and distribution sectors. Fahed Group is a majority shareholder in Karim Trading SAL, an import and distribution company of food and FMCG products, the distributor of Jolly Time Popcorn in Lebanon; Hadaya Al Beit SAL, a major distribution company of household products; and Fahed International Development Company SAL, a real estate development company. Principals of the Group also have ownership in Fahed White Collection, a retail store of lingerie, bedding, and a linen line of products, in Fahed Supermarket-Jounieh, and Fahed Supervalue-Zalka, major supermarkets in Lebanon.

Bilal HaidariPresident/Owner AGA WorldwideTel: +961 1 242999www.agaworldwide.net

AGA Worldwide is a U.S.-based logistic services company that provides inland delivery of goods and purchases from all over the states in America to the ports of export. The operation field of AGA Worldwide extends to loading the delivered goods in containers safely and professionally, having it cleared through customs, and, finally, shipped overseas with accurate shipment tracking. In other words, AGA Worldwide represents a specialized broker for the above mentioned services, and this could be reflected in managing the paperwork, saving our clients time and money by handling the complete logistics involved in the purchase and the shipping of items from place of purchase to their destination country.

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Eaternity’s mission is to provide its customers a high-quality product in a friendly atmosphere, following the highest hygiene standards. Eaternity also aims to be a second home to its employees by providing swift career expansion in a pleasant and professional environment.

Eaternity is a family-owned food and beverage management company established in late 2011 by the Zantout family. Eaternity acquired Magnolia Bakery, its first international franchise, in 2012 and opened its first outlet in Lebanon in December of the same year and its second outlet in October 2013. In January 2014, Eaternity signed a master management agreement with Magnolia Bakery New York covering MENA and other countries.

Omar ZantoutGeneral ManagerEaternity SALTel: +961 4 545948

American Lebanese Chamber of CommerceDirector Paola ChakhtouraAddress 1153 Foch Street Beirut Central DistrictP.O. Box 175093 Beirut, LebanonPhone/ Fax +961 1 985330-1Web www.amcham.org.lbE-mail [email protected]

Board of Directors and Officers

Salim J. Zeenni ChairmanMaher Y. Beydoun VP for Public RelationsArslan M. Sinno VP for MembershipRichard A. Haykel VP for International AffairsWalid T. Assaf TreasurerNadim Kassar Secretary GeneralRabah Jaber Board MemberCarol Chammas Kareh Board MemberNadim Romanos Board MemberHani Raad Board MemberBarbara Batlouni Board MemberGaby Tamer Board MemberFady Khayat Board MemberElissar Farah Antonios Board MemberJean Riachi Board MemberBana Akkad Azhari Board MemberFadi Saab Board Member

Members News

Century 21 1st. Global Lebanon received an award for Best Real Estate Agency in Lebanon from the International Property Awards. Century 21 1st. Global Lebanon competed against a number of real estate professionals in Lebanon to receive this recognition. The Middle East’s finest estate agents and property consultants gathered to attend a glittering gala and to hear the long-anticipated results of the International Property Awards regional competition.

Awards were given out for the region’s best real estate agencies, property consultancies and lettings agencies. Each winning company was

announced as either a ‘Highly Commended’ or ‘5-Star’ winner and presented with special plaques during the awards ceremony.

Stuart Shield, president of the International Property Awards, said, “These award-winning real estate professionals are setting the standard for the region, which has become one of the hottest property markets in the world. Through their work the Middle Eastern real estate industry continues to flourish and to successfully attract more investors and buyers.”

CENTURY 21 1st. Global LEBANON Receives Award for Best Real Estate Agency

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Winter 20146

As part of a strategy to expand its portfolio of personal care products and to launch into new markets, Cosmaline just completed a restaging of key products based on beauty trends and consumer surveys. “Our policy has always been to meet the beauty needs of our growing clientele with high-tech, modern, effective and feel-good products,” explains Rebecca Atamian, Marketing Manager of Cosmaline. “The restaging of a brand also allows us to take a well-known and trusted product, upgrade it and give it a more contemporary look. And it is the ideal way to launch into new markets.” she says. Recent restaging includes FixNet Pro. Gel which provides men with an unbeatable formula in a variety of different fragrances encased in modern and masculine packaging. Its female versions for mousse and spray embody all that is luxurious about hairstyling for women with powerful packaging on par with an effective formula for any look. In addition, the Soft Wave Shampoo and Soft Wave Kids range underwent a total restage, providing end-user consumers with a wide selection of hair solutions with effective and safe ingredients. “With our products already available in the Levant, Kuwait, Bahrain, Ghana, the Ivory Coast and Cyprus, we will be looking to

further expand into high potential markets in the GCC and Africa in the coming year,” concludes Atamian.

For more information, please contact us on [email protected] Tel. +961 1 888 306.

On December 4, 2013, longtime AmCham member Mr. Nassif Naim Saleh was bestowed the “Order of the Italian Star - Stella D’Italia - rank of Knight,” in recognition of special merit and direct warship services rendered to the Italian Navy and Nation, along with his dedication to strengthening relationships between Italy and Lebanon.

This rare decoration was granted by the Italian Ambassador Giuseppe Morabito, on behalf of President Georgio Napolitano. By awarding Mr. Saleh this prestigious decoration, the President of the Italian Republic wanted to honor him and for his professional and human qualities.

Mr. Nassif Saleh is the only agent that enjoys the Maritime Qualification NAMSA (NATO Maintenance and Supply Agency) in Lebanon. In addition, Saleh Shipping continues as the sole Port & Chandler Agent for prime Western navies calling in Lebanon, namely, the United States, Italy, Canada, Britain, Spain, Belgium and NATO.

Nassif Saleh Award

Cosmaline Undergoes Restaging and New Market Launches

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AIMS Expanding into Africa

AIMS S.A.L. has been in the market since 1987. Today, thousands of users spread across 22 countries are using Socrate as their main package for business solutions in Entreprise

Resource Planning. Four telecomm operators in Africa started using Socrate as the backbone of their ERP system. Africell Gambia, Lintel Sierra Leone, Africell RDC Sprl Congo, and Vivacell have all met Socrate and discovered how it can benefit their companies. An easy setup, a satisfiying solution specifically customised to

meet their business needs, and the ongoing afterservice that will come with a duty to help them convey a productive service exceeding their customer satisfaction.

Whether a small or a big institution, looking for just an accounting package or a complete ERP system, Socrate has it all in its range of products and modules, the solution that will best fit the user’s needs, and provide the handler with a powerful, yet user-friendly solution, to streamline all business applications.

For more info, please contact us at +961-9-636985 [email protected]

The Shiseido Day Spa Launches World Premiere In Beirut

In a first for the region, the Shiseido Day Spa was selected by Shiseido Europe to premiere the brand’s exclusive ONJAKU treatments. “We were delighted to be chosen for the launch,” said Nicole Sarraf, Vice President of Fashion & Luxury at Malia Group. “As opposed to other Shiseido Spas, we are unique in that we cater directly to the Shiseido clientele without being part of a larger hotel complex. This makes the feedback more precise and intimate since guests to the Spa are very familiar with the brand.” The ONJAKU collection of treatments uses basalt stones to release energy flows, relax muscles and act as an anti-aging agent. Using stones from the Arizona desert and Shiseido’s unique massage techniques,

the treatments ensure that warmth deeply enters your meridian, making you feel indulged in every moment and allows for the flow of positive energy. “We can safely say that the feedback has been very encouraging for Beirut and that, as a result, Shiseido Europe will be rolling it out in other markets,” concludes Sarraf.

For more information & bookings, please call the Shiseido Day Spa, Tel. +961 1 332277

FOR RENTAmCham has 1 or 2 furnitured offices for temporary rent

including the use of a conference room and all facilities and services (internet, phone, fax, printer/photocopy machine,

administrative services).For more information call 01-985330

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On December 13, 2013 Al Wafic for Economic Development and Investment, an NGO, and the American Lebanese Chamber of Commerce, in cooperation with MEFOSA (Middle East Food Safety Associates) and the Chamber of Commerce, Industry and Agriculture of Beirut and Mount Lebanon, organized a successful conference entitled, “Food Safety Modernization Act (FSMA), a New Paradigm in Food Safety: Lebanese Challenges and Perspective.”

The conference opened with the Lebanese national anthem, followed by remarks by Mr. Atef Idriss, the founder and President of Al Wafic and CEO of MEFOSA. Mr. Idriss addressed the future of Lebanese food exports, as the new FDA FSMA law puts new preventive food safety requirements on food products exported to the U.S.A. Mr. Arslan Sinno, Vice President of the American Lebanese Chamber of Commerce (AmCham), presented current trends in food production and consumption and the implications on the need for food safety. Mr. Mohamad Choucair, President of the Chamber of Commerce, Industry and

FDA “Food Safety Modernization Act” SeminarAgriculture of Beirut and Mount Lebanon, insisted on the importance of working in compliance with international food safety laws, in addressing the health of Lebanese citizens, and the need to export to the U.S.A. H.E. Mr. Nicolas Nahas, caretaker Minister of Economy and Trade, was represented by Mr. Roger Melki who spoke about the distribution of responsibilities between the Ministries of Industry, Health, and Economy and Trade in controlling food products in Lebanon. At the end of the opening ceremony H.E. Mr. Vreij Sabounjian, caretaker Minister of Industry, also addressed the importance of compliance of Lebanese food products with international standards. His Excellency insisted that Lebanese food production, storage and transportation should be safe and should not negatively affect the quality of the products and the health of consumers.

Dr. Leila Batarseh, Middle East and North Africa Regional Office Director at the U.S. Food and Drug Administration (FDA), connected with the audience via video conferencing to explain the FSMA law in general, the proposed rule for Preventive Controls for Human Food, the Produce rule, and the Foreign Supplier Verification Program. In addition, Dr. Batarseh participated in another session to address the Accreditation of Third Party Auditors, the import data and refusal charges, the step by step food facility registration for FSMA, and the FDA food labeling requirements.

The conference’s program included presentations on Lebanese related topics. MP Dr. Atef

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Majdalani, Chairman of the Health Committee in Parliament, addressed the issues of the Lebanese Food Safety Authority and the Lebanese Food Safety Law updates. Dr. Walid Ammar, Director General of the Ministry of Health, represented by Dr. Assaad Khoury, spoke about the role of the Ministry of Health in regards to the FSMA law, and the importance of a robust food regulatory system for health in Lebanon.

The conference also emphasized the role of food labs, where Dr. Ghazi Zaatari, Director of the Environment Core Laboratory of the American

University of Beirut (AUB), gave a presentation about the “Role of Lebanese Labs: Certification and Accreditation.” In addition, Dr. Khaled El Omari, the head of Quality Control Center Laboratories and Research and Development at the Chamber of Commerce, Industry and Agriculture of Tripoli and North Lebanon, made a presentation about the detection of root causes of unsafe food contaminants and pathogens in the food lab.

Ms. Hiyam Kojok presented the QUALEB Safety Issues of Lebanese Quality Infrastructure, and Mrs. Maya Nohra presented LIBNOR’s corrective actions to date. In addition, Mr. Elias Abou Fadel made a presentation about the Ministry of Economy’s project on economic mapping of new regulations, and Dr. Zouhair Berro commented on preventive actions for the protection of consumers in Lebanon.

The conference ended with a keynote speech by Mr. Mounir Bissat, President of the Syndicate of Lebanese Food Industrialists, on the actual situation of Lebanese food industrialists.

US Trade Fairs

Listing for International Buyer Program (IBP) 2014http://www.export.gov/ibp/ibp.asp?ReportID=IBP

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Awards, Chairmanship Transfer, and Board MeetingAmCham MENA Regional Council: Women in Business

Members of the AmCham MENA Regional Council – representing the AmChams of Abu Dhabi, Algeria, Bahrain, Egypt, Jordan, Lebanon, Morocco, Palestine and Tunisia – met in Casablanca, Morocco on December 7 to recognize the winners of the 2013 AmCham MENA Regional Council Women in Business Awards program for their outstanding achievements in the corporate, entrepreneurship and non-profit sectors. The Award Ceremony was hosted by AmCham Morocco as part of its special Gala Ball.

The MENA Women in Business Awards program was initially launched in 2012 with a mission of recognizing women from the region who have set the benchmark for others to follow and are an inspiration for future generations of women from the MENA Region.

Each of the eight MENA Council member AmChams nominated candidates for this year’s awards. A panel of judges from around the region brought diverse perspectives and knowledge to the process, and cast their votes for all three categories. Three winners were recognized during a special gala dinner.

Winners of the 2013 MENA Council Women in Business Awards:

• Best Woman in the Non-Profit Sector Ms. Leila Benhima Cherif The Heure Joyeuse (MOROCCO)• Best Woman in the Corporate Sector Ms. Nevine El Tahry Delta Shield for Investment (EGYPT)• Best Woman Entrepreneur Ms. Amal Dargaghmeh Masri Ougarit Group (PALESTINE)

The MENA Council also had its annual board meeting at the AmCham Morocco premises on December 7. This year’s meeting marked the transfer of the Council’s chairmanship for the past two years from AmCham Tunis to AmCham Abu Dhabi. Mr. Mathew E. Byrd, President of AmCham Abu Dhabi will be the Council’s new Chair.

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FDA Update

The New Drug Quality and Safety Act

On Nov 27, 2013, President Barack Obama signed the Drug Quality and Safety Act which established a national track-and-trace system to secure the medicine supply chain. The program will reduce the ways that criminals can infiltrate the legitimate supply chain with counterfeit, adulterated, diverted or contaminated drugs. This law will dramatically improve the safety of compounded drugs and will also establish an unprecedented tracing system that will track prescription drugs from manufacturing to distribution. This will require manufacturers, repackagers, wholesale drug distributors, and dispensers (other than most licensed health care practitioners) to provide product and transaction

information with each sale and notify the FDA.

Starting four years after enactment of the law, manufacturers, followed by repackagers, will be required to affix a unique product identifier to each drug package that contains the drug’s national drug code (NDC), serial number, lot number, and expiration date. Starting six years after enactment of the law, wholesale drug distributors, followed by dispensers, may only trade products that are encoded with product identifiers and will be able to verify the product identifier if they determine that they have a suspect product. Ten years after enactment, supply chain stakeholders and FDA will benefit from an electronic, interoperable system which will facilitate the efficient exchange of product and transaction information for

FDA News as received from Layla Issa Batarseh, Ph.D., Middle East and North Africa Regional Post , Senior Regional Advisor, Office of International Programs, U.S. Food and Drug Administration at the US Embassy in Jordan

About the MENA Council of Regional AmChams

The AmCham MENA Regional Council (MENA Council) was established in 2005, and comprises the AmChams of Abu Dhabi, Algeria, Bahrain, Egypt, Jordan, Lebanon, Morocco, Palestine and Tunisia.

The objective of the Council is to work on promoting greater business opportunities between the U.S. and the Middle East and North Africa region. The Council works on effectively linking the various members, and institutionalizing their ongoing coordination with the U.S. Chamber of Commerce. It also works on promoting free trade agreements between MENA countries and the U.S. and on fostering increased awareness among MENA region manufacturers and producers of export opportunities to the U.S. through those agreements.

The AmCham MENA Council Chair is currently AmCham Abu Dhabi. The Council’s permanent Secretariat resides at AmCham Egypt.

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prescription drugs at the individual package level. The system, when fully implemented, will enable verification of the legitimacy of the drug product identifier down to the package level, enhanced detection and notification of illegitimate product, and improved efficiency of recalls.

The Drug Quality and Security Act is available at: http://www.gpo.gov/fdsys/pkg/BILLS-113hr3204enr/pdf/BILLS-113hr3204enr.pdf

Important Announcements from the U.S. Food and Drug Administration

DRUG SHORTAGES

The FDA has released a long-term strategic plan to outline the agency’s priority actions, as well as actions drug manufacturers and others can take, to prevent drug shortages by promoting and sustaining quality manufacturing.

The FDA has also issued a proposed rule to implement a provision in the Food and Drug Administration Safety and Innovation Act of 2012, which would require that all manufacturers of certain medically important drug and biologic products give early notification of a potential drug shortage and report reasons for the potential shortage.

Drug shortages are a complex, ongoing problem with interrelated causes that can result in serious or even deadly outcomes for patients who cannot get the medications they need. The FDA continues to make progress in preventing and mitigating drug shortages, but the agency must have the cooperation of drug manufacturers and others to address this public health threat.

Following the President’s 2011 Executive Order on reducing drug shortages, the number of new shortages in 2012 was 117, down from 251 in 2011. The FDA has made important progress in addressing drug shortages, and FDA’s new strategic plan and proposed rule will provide the agency with additional tools and information to combat drug shortages.

For further information:

• Drug Shortageshttp://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm • Biological Product Shortageshttp://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Shortages/default.htm• Consumer Updatehttp://www.fda.gov/ForConsumers/ConsumerUpdates/ucm370495.htm • Executive Order 13588http://www.whitehouse.gov/the-press-office/2011/10/31/executive-order-reducing-prescription-drug-shortages • Frequently asked questions about drug shortageshttp://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050796.htm

GENERIC DRUG SUBMISSIONS

The Food and Drug Administration (FDA) has announced the availability of a draft guidance for industry entitled “ANDA Submissions—Refuse-to-Receive Standards.” This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and related submissions (i.e., prior approval supplements (PASs) for new strengths). The guidance contains details on what should be included in these submissions and highlights serious deficiencies that may cause FDA to refuse to receive the submission.

For further information: • Announcementhttps://www.federalregister.gov/articles/2013/10/01/2013-23793/draft-guidance-for-industry-on-abbreviated-new-drug-application-submissions-refuse-to-receive • Draft guidancehttp://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm370352.pdf • Send general questions to [email protected] • Send technical questions related to submissions to [email protected] • To receive additional updates as they become available, sign up on the GDUFA webpage www.fda.gov/gdufa

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Interact 2014

Interact is intended to promote business between AmCham members and to stimulate intra-AmCham business relationships. The program allows you to inform fellow members in Lebanon, as well as members of the AmCham MENA Regional Council (AmCham Abu Dhabi, Algeria, Bahrain, Egypt, Jordan, Morocco, Palestine, and Tunisia) of any business offers or benefits you are willing to give them exclusively. AmCham members are privileged to benefit from other MENA AmChams’ offers, making this an opportunity for members to present each other with products and services at favorable terms and conditions, hence increasing business between them.

Send your offers for 2014 to [email protected]... and begin to interact!

Almaz Jaber Group, co-founder of a hotel chain of five and four stars located in Beirut, offers all AmCham members a discount of 20% on accommodation as a special rate. The hotels featured are as follows:

• Lahoya Suites, Lahoya Homes, and Lahoya Gardens, located in Ain elMreysseh Website: www.lahoyabeirut.com

• Lahoya Verdun, located in Verdun• Imperial Suites Hotel, located in Raouche

Website: www.imperialsuites.com.lb

Furthermore, as manufacturers of Gaz cylinders, our company is specialized in and qualified throughout the region in the production of LPG gas cylinders in different sizes, and exporting the cylinders to different countries. Our fabricant factory, Sigma Gaz, is situated in Tanaayel in the Beka’a region of Lebanon. If any members are interested in Gaz cylinders, we would be available and are ready to cooperate.

We are also in the construction sector, as our company Jaber Group Real Estate, specializesin establishing and reconstruction of luxury buildings and large apartments in Beirut.

For more info and reviewsvisit: www.jabergroup.com

Click the following link for the offer: http://amcham.org.lb/pdf/adir2014.pdf

For more info call: Ms. Rita Fahed on 961 1 256290 Ext: 209

10% on all ICTN offerings in its 2014 workshops calendar in all categories:

• Business Development• Communication• Creativity and Innovation• E-commerce• Events• Finance, Accounting and IT• Hospitality Management• Human Resources• International Accreditation and Certification

Programs• Leadership, Management and Administration• Legal• Operations and Quality Management• Personal Development• Sales, Marketing and Customer Service• Team Building• Training and Development

For more info call: +961-1-897353, ext 111

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Winter 201414

AMIDEAST, a regional leader in training and assessment, offers all AmCham members a 10% discount on the following services in Lebanon:

English Language Assessment and Training

• Assess the real English skills of your potential new hires and current employees to save time and money on training. The Test of English for International Communication (TOEIC®) is the global standard for measuring workplace proficiency in English language.

• Are the English skills of your employees as good as they need to be in this global market? We offer Public English Language Courses and Company-Sponsored Business English Courses.

Training Workshops

We offer many public and sponsored training workshops each year. Upcoming topics include:

• Project Management Professional • Green Building LEED • Communication & Negotiation• HR Series Workshops• Sales Team Development • Presentation Skills• Certified Associate in Project Management• PM Series Workshops• Growing a Business• Starting a Business

To discuss training and assessment needs, and how AMIDEAST can help your company,

Call: Raya at +961-1-989901, ext 132 Email: [email protected]

Visit: www.amideast.org/lebanon

Crown House, the leader in office furniture and the exclusive dealer of Steelcase U.S., is offer-ing a 10% discount on all Steelcase products.

For more infoCall: 04 409383 Ext: 109

Email: [email protected]

Try the International New York Times and save 25% off the cover price. Order a 12-month subscription to the International New York Times for only LBP 900,000 or USD 595. Of-fer includes free INYT Digital worth US $35 per month.

For more info call + 961 1 512 215Email [email protected]

Please quote AMCHAMINYT

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Winter 201415

Free Diagnosis or Consultation on any Financial or Cash Flow Management, Accounting, Audit or Tax Issue

Embracing International Concepts and High Standards, BSF, with its Financial Management/Business Advisory/ Expertise, supports BUSINESS OWNERS, CEOs, CFOs & FINANCE DEPARTMENTS to:

• Control companies’ operations from all the angles & make better business decisions • Transfer distinctive knowledge, skills & values to Finance Departments• Provide audit assurances the business is running according to received financial information ‘True & Fair View’ & controls’ weaknesses are improved

One of BSF’s exclusive & of high value part-time CFO services is to EMPOWER companies with a ‘Customized-Per-Industry/Company’ Financial Management Reporting System to assist management in:

• Enhancing visibility, strategies & execution, growth, profits & cash• Selling more & focusing on higher value revenue goods & services • Optimizing costs & processes• Identifying business patterns & changes • Staying prepared for any emergency

BSF, in collaboration with Executive Education, USA, with 50+ different Financial Training Workshops based on real-world corporate experience, brings American education to companies in the Middle East. These workshops are specifically designed for key & strategic professionals and focused on issues companies face today.

BSF offers AmCham members up to 20% discount on Public/In-House/Individual/Customized Training.

Telefax: +961 1 385 [email protected]

Albert Haykel Hospital offers AmCham members a 25% discount for a complete physical check-up program in addition to a 15% discount on The Multi Slice CT.

For more info call: 961 6 411111www.hopitalhaykel.com

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Winter 201415

President Obama announced the SelectUSA initiative to showcase the United States as the world’s premier business location and to provide easy access to federal-level programs and services related to business investment.

SelectUSA is designed to complement the activities of our states—the primary drivers of economic development in the United States.

SelectUSA seeks to highlight the many advantages the United States offers as a location for business and investment. From a vast domestic market, to a transparent legal system, to the most innovative companies in the world, America is the place

The Fancy Food Show is North America’s Largest Specialty Food & Beverage Event will be in New York City from June 29 - July 1, 2014. Over 180,000 products including confections, cheese, coffee, snacks, spices, ethnic, natural, organic and many more will be

displayed. Connect with over 2,000 exhibitors from 80 countries & regions.

If you are interested in attending this show, please contact Mrs. Maya Barhouche at [email protected] or on 04-544860.

AmCham members will receive 5% discount on fare in Economy Class, and 7% in Business class (promotions exempted), if they register in Lufthansa’s SME program www.partnerplusbenefit.com and book through the Lufthansa office in Beirut

For more info call: +961 34 7007Email: [email protected]

At Hilton Hotels Beirut you can unwind in our exquisite restaurants, invigorate your body and mind in our 3500 sq. Elixir Spa & Health Club, and spend memorable nights in our elegant guest rooms and suites.

As a special offer to AmCham Members we are extending a 15% discount in all our restaurants and spa.

You can also ask for the Amcham corporate room rates and benefit from additional discounts.

For more info, contact Georges Karam, Director of Business Development, on [email protected]

Terms and conditions apply. This offer is valid until the end of June 2014.

for business. More information can be found on http://selectusa.commerce.gov/

US Embassy Announcements