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Virtual or remote (decentralized) clinical trials – new trends

The COVID-19 pandemic significantly accelerated the adoption of decentralized clinical trials. As health system resources were expended on COVID-19-related care and travel became limited by physical distance, patient access to research facilities decreased by 80 percent.[1] In the face of such disruptions, sponsors quickly mobilized to maintain continuity of care and data integrity – for example, by adopting remote patient consent and monitoring. Although some elements of decentralization of clinical trials existed before the COVID-19 pandemic, they were not widely used in trials. And as the global pandemic continues, a consensus is emerging that many interventions will become permanent. Tools such as electronic consent, telehealth care, remote patient monitoring, and electronic clinical outcome assessments (eCOAs) make it possible to maintain contact with study participants without in-person visits.

Defining decentralized clinical trials and trying to understand them

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Cracow’s investment potential

The newest Business Center in Krakow

In recent years, Cracow has been very popular in terms of investment. It ranked third in the Business Environment Assessment Study (BEAS) 2021. Various factors were taken into account during the evaluation, such as educational potential, employment potential, location or business potential.

What the Business Environment Assessment Study (BEAS 2021) presents?

The Business Environment Assessment Study (BEAS 2021) is a research cycle conducted by Antal – company specialising in HR consultancy and Cushman & Wakefield – real estate experts. In 2021, the third edition of the cycle took place. As part of this cycle, a report entitled Investment potential of Cracow was prepared and presented on Tuesday, October 19, 2021. Thanks to the conducted research we can find out what are the current trends in economic development on the Polish market.

In the face of the pandemic and the economic crisis, the subject of investment has become much more complicated. According to experts, currently the key to investments will be the optimization of costs while increasing the efficiency of operations, also in the case of remote working.

What are the factors that influence investing in Cracow

The report lists the following factors for investment incentives: infrastructure, educational potential, employment potential, business potential, public administration support, office space, evaluation of the location as a place to live. It mentions also cost of living and the level of wages.

Of the above-mentioned factors, the following can boast a high rating:

  • educational potential (7.9)
  • location rating as a place to live (7.1)
  • business potential (7.0)

Investment potential in Poland

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Opening of the Chinese market for Polish cosmetics

Polish companies are willing to start selling cosmetics in China, however still some formal requirements stand in the way. China has recently changed its cosmetics industry regulations. Until May 1 2021, China required importers to test cosmetics on animals. It was an insurmountable barrier for European producers, because the European Union has been banned from testing cosmetics on animals for many years. Now the Chinese are demanding a certificate of Good Manufacturing Practice. It is to certify that the preparation was developed under the conditions and standards imposed by an international standard. Such certificate should be issued by the supervisory authority. The Polish certificate has not yet been created, although its content was proposed by the Polish Union of the Cosmetics Industry during the summer holidays in 2021. The Union brings together over 220 companies, including manufacturers, distributors, laboratories, consulting companies and teaching centers.

Without a proper certificate and without an efficient procedure for issuing it, the Polish cosmetics industry loses its competitiveness against other Western countries on the world’s largest market.

Experts in Poland emphasize at the same time that the certificate is not everything. It is still necessary to develop an instruction for its issuing, which will go to the poviat (local level) health care centers.

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The creation of the European Startup Nations Alliance (ESNA)

The Portuguese government, in partnership with 26 EU Member States, Iceland, and the European Commission, has launched the European Startup Nations Alliance (ESNA) on 3 November 2021.

The European Startup Nations Alliance (ESNA) is a new entity that will support 26 EU Member States and Iceland who, having signed the EU Startup Nations Standard (EU SNS) declaration in March 2021, commit to ensuring their startups have the best conditions to grow at every stage of their life cycle.

ESNA will support these countries’ efforts to become a ‘startup nation’. It will do this through:

– sharing of best practices as set out in the EU SNS;

– providing technical support to countries to concretely implement changes;

– monitoring progress.

ESNA will work closely with the 27 European countries that have signed up to the EU SNS and support them in implementing the 8 underpinning standards:

– fast startup creation and smooth market entry (e.g. setting up a new company within one day);

– attracting and retaining talent (e.g. an accelerated visa process for tech talent from outside the EU);

– stock options (e.g. no taxes for stock options before being cashed in);

– innovation in regulation (e.g. regulatory sandboxes allowing startups to experiment);

– innovation procurement (e.g. removing administrative impediments that would put startups at a disadvantage);

– access to finance (e.g. increasing the amount and diversity of growth capital);

– social inclusion, diversity and protecting democratic values (e.g. incentives to hire on diversity of gender, ethnicity, age and religion);

– digital-first (e.g. all interactions between authorities and startups via digital interfaces).

The launch of the ESNA took place during the second day of the Web Summit in Lisbon, officiated by the Portuguese Minister for the Economy Pedro Siza Vieira.

The ESNA will also support countries that hold the rotating European Council Presidency. It will do this via the ‘ESNA Presidency Board’ which ensures ESNA can align its actions with the priorities of rotating presidencies.

https://digital-strategy.ec.europa.eu/en/news/new-european-alliance-accelerate-startups-growth

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KIELTYKA GLADKOWSKI WILL PARTICIPATE IN GLOBAL CLASS ACTIONS SYMPOSIUM 2021

On 16 and 17 November 2021 KIELTYKA GLADKOWSKI will participate in Global Class Actions Symposium 2021 organised by ICLG.com. With 14 panel discussions across the two days, expert speakers will cover topics including:

Funding international collective proceedings

Settlements of global disputes

Planning Global Strategy

Class action for breach of data protection

Competition claims

ESG claims

Global trends in securities litigation

Consumer protection

Calculating damages in cross-border cases

Since class actions expertise, with heavy emphasis on cross border aspect, is one of the key specialisations of KIELTYKA GLADKOWSKI, the participation in the event will allow our lawyers to gain more insight into current trends and strategies within global class actions.

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