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SMO-GROUP NEWSLETTER Issue 14 1d1d11

Newsletter April 2018

IN THIS ISSUE:

 Reduction in taxes - The opportunity to increase investment for the development of new markets for clinical devices in Ukraine

 2nd of April is the international day of distribution information concerning autism problem

 Openhearted  Moving to new office  BIO 2018: First time for SMO  SMO Israel Named Official Gold Sponsor of Major Conference


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Reduction in taxes - The opportunity to increase investment for the development of new markets for clinical devices in Ukraine. By Vita Nosulenko

As of the 1st of January 2018, we are pleased to share the latest updates of the solution to one of the most pressing problems for companies supplying medical devices into the territory of Ukraine. The Cabinet of Ministers of Ukraine has revoked the necessity for the document entitled ‘Sanitary and Epidemiological Conclusion’ for medical devices imported into the territory of Ukraine. A CMU Resolution announced a formal resolution on the 31st of January 2018 formally documented as Order No.44

What is the new situation?

What was needed!

The document includes provisions repealing the need of sanitary and epidemiological expertise for medical devices imported to Ukraine on the basis of a conformity declaration or a conformity certificate according to Decree of the Cabinet of Ministers No.753, No.754, No 755 of 2 October 2013.

The need to exempt medical devices from sanitary and epidemiological control arose in February 2017. The EBA Health Care Committee, including SMO-Group, noted that the transition of Ukraine to the conformity assessment system in accordance to EU legislation established the availability of conformity declaration or conformity certificate by which manufacturer states that the product satisfies the essential legal requirements. The decision was also necessary for avoiding delays with medical devices’ supplied to Ukrainian patients.


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Thanks to all of you The problem was resolved with the assistance of the Ukrainian Ministry of Health of, The Ministry of Economic Development and Trade of Ukraine, The Ministry of Finance of Ukraine, the State Fiscal Service of Ukraine and the State Service of Ukraine for Food Safety and Consumer Protection.

First and foremost, this is a significant saving in the budgeting of projects, which currently is the main consideration, especially for small biotech companies who would like to start a study in Ukraine.

Please take part! We are determined to make ongoing improvements to logistics services worldwide through productive cooperation. The SMO-Ukraine team would like to appeal to all readers and in particular, companies operating in the clinical research industry in Ukraine, Georgia, Israel, and any other country where we are present, to help us solve the problems that exist in our industry. Let us join forces with the aim of solving them.

In cooperation with government agencies, the SMO Legal Group, in association with the initiative representatives of other companies that are part of the Subcommittee of Clinical Trials under the European Business Association, has had a positive and meaningful influence in achieving a successful outcome in this matter. The total availability of such benefits has a very positive effect on the decision of sponsors to choose Ukraine as a country for conducting clinical trials.


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2nd of April is the International day of distribution information concerning autism problem By

Oksana Mykhalchuk

The topic of the day in 2018 is “Empowerment of women and girls with autism”. By Vita Nosulenko

SMO-Group, as a member of clinical trials, is guided by the main principles of ethical business and has set, as one of its’ highest priority goals for the current year – the active participation in the social governmental programs. Our purpose is to adopt reforms in the Healthcare sphere. We believe that Companies can significantly help to bring the positive changes required in a country’s and its inhabitants lives, and we must act now to help this process.

20-21 of April 2018, Kyiv In November 2017 the United Nations General Assembly adopted resolution emphasizing specific problems facing women and girls:  The girls are less likely to finish primary school and are most likely to lack access to education  The women have lower employment rates than disabled men  On a global scale, women face physical, sexual, psychological and economic abuse more often than men.

SMO-Group will participate in the Conference on methods of communication with autistic people – “DIRFLOORTIME, ergotherapy and sensory integration for all”.


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Openhearted By

Alla Pitko

In March of this year, our colleagues, Tamar Bolkvadze – Director of SMO-Group Depot in Georgia and Alla Pitko – Market DevelopBy Vita Nosulenko ment Manager visited the charity organization Catharsis, which is based in Tbilisi.

and meaningful and worthy of publication (all great books are based on true stories). For some, Catharsis is a place to find and mix with like-minded people, like a club.

It was established in 1990 and is one of the oldest non-governmental organization in Tbilisi, which cares for disadvantaged groups Every day Catharsis serves lunch for about 300 people. These people are in need of help for a variety of reasons. Inga (Director of Catharsis) told the story of how the organization was established and the equipment that is available in the building.

Home for destitute

People meet there, talk, play chess, read books, and create their own performances in a small room, equipped as a theater. Some also take advantage of the facilities to pray. Loneliness is hard for most people but especially so for the elderly. Catharsis is doing great job helping people and the value to the community cannot be overstated. It is a great honor for SMO to be part of this great mission to help the vulnerable in society.

Catharsis is also a home for the elderly. Elderly ladies, who are resident there, all have their own personal stories, each story is unique

It should be easy to help others…it just requires people to start with the first step.


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Moving to new office By

Oksana Pidmogylna

Dear Partners! As a result of the recent significant growth of SMO, the main operational Ukrainian By Vita Nosulenko office moved to a new business center at the beginning of 2018. The business center is located near to Kyiv’s main transport links. We can now be found at the following address: 9-B, Smolna street, BC “Gloria”, 03022, Kyiv, Ukraine.

Our new facilities include a comfortable client area suitable for internal activities and meetings. The convenient location in a dynamic business district that allows easy access from any district of Kyiv or airports Other locations remain unchanged. We are always delighted to meet guests, both at our depots and offices! We look forward to welcoming you!


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BIO 2018: First participation for SMO By

Oksana Pidmogylna

SMO Group representatives attended the BIO-Europe Spring Conference in Amsterdam on 12-14th of March 2018. By Vita Nosulenko

A huge three-day event was divided into several sections in the form of plenary sessions, speeches, and workshops, dedicated to the most topical questions of the time such as Brexit, FDA strategies, R & D trends and much more. Also, the role of cross border collaboration in the development of a global biotech industry was discussed as well as innovative approaches to funding vaccines for emerging pandemics. In addition, new associations were formed to create productive, collaboration forums for future developments.

BIO SPRING is an important event in the pharma industry that assembles the largest audience of professionals. It is a partnering platform for representatives from biotech and pharma companies on a worldwide level. This year the SMO-group participated in the event sharing valuable experience with partners, making new business contacts, promoting company' services for new audience and treating all visitors to the SMO booth, a tasty coffee, Ukrainian chocolate and liquors (only afternoon ď Š).

That goes for all of us The impact of recent changes in Europe, Asia, Australia, collaborating with companies in a future pharmaceutical R&D super power, and as a financial hub for economic growth, was one of the top-issues.

Afterwards When attending an event on such a massive scale it is very difficult to assess their effectiveness after just a few months after. However, the SMO team is keen to be there, to be among professionals at such a level, speak to each other, share experiences and understand the experience of others. We can then take this useful knowledge to our own country to implement the best practices here. Moreover, we believe that there is a need to expand the geography of the provision of high quality services and our team is actively working on it. We would like to express our gratitude to all the participants of the conferences. It was a great experience and a new beginning of the future development of Biotech and Pharma.


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SMO Israel Named Official Gold Sponsor of Major Conference By

Gal Alterovich

By Vita Nosulenko

Having established its position as a prominent force in the Clinical Trial Logistics industry in Israel, it is no surprise that SMO Group has been selected to support the industry-leading conference. SMO Israel has been named as the gold sponsor for the Annual Conference for Research and Clinical Trials, Israel. The conference will take place at the Dan Panorama Hotel, Tel Aviv, on the 24th April, 2018.

SMO Group’s Israeli facility was opened in 2011 to provide services to the major life sciences and pharmaceutical companies conducting clinical trials in Israel. The GMP certificate granted by the Israeli Ministry of Health recognizes the high quality of services provided by the company in full compliance with the latest clinical trial frameworks.

SMO Israel has invited Dr. Andrea Zobel, the senior director clinical trial supply and logistics at Parexel, to present a lecture "Clinical Research in the Era of The Internet of Things.�


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SMO-Group Newsletters

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For additional information, please contact: Vita Nosulenko Business Development Manager vita.nosulenko@smo-group.com Oksana Pidmogylna Marketing Manager oksana.pidmogylna@smo-group.com

SMO-GROUP Newsletter, Apr 2018  
SMO-GROUP Newsletter, Apr 2018  
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