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ENSafrica | April 2020

World: The COVID-19 pandemic has prompted all destinations worldwide to introduce restrictions on travel, research by the World Tourism Organization (UNWTO) has found. This represents the most severe restriction on international travel in history and no country has so far lifted restrictions introduced in response to the crisis. Following up on previous research, the latest data from the United Nations specialised agency for tourism shows that 100% of destinations now have restrictions in place ...

PLMJ | October 2020

Due to the worrying evolution of the epidemiological situation currently afflicting the country, Presidential Decree no. 276/20 of 23 October 2020 has been enacted to update the preventive and control measures for the spread of COVID-19. Overall, there is a strengthening of the previous preventive measures established in Presidential Decree no. 256/20, of 8 October 2020 ...

Waller | March 2020

Soccer matches played to 100,000 empty seats. Marathons with 200 runners in silent streets. Business blocks deserted. Restaurants closed. Those areas hardest hit by coronavirus can look like something out of an apocalyptic movie. And now, just two months after the new type of virus was first identified in China, Coronavirus-2019 (COVID-19) has hit the United States. According to the Centers for Disease Control, coronavirus has been found in over 80 countries and 13 U.S ...

Waller | March 2020

1. Has OSHA developed standards specifically with respect to COVID-19, or coronavirus? At this time, OSHA has not created specific OSHA standards for COVID-19. However, OSHA is carefully monitoring the situation. It has created a centralized website for employers to familiarize themselves with the disease, including its transmission and what can be done to protect employees ...

Waller | March 2020

As we continue to be bombarded daily with the relentless 24/7 news cycle regarding Coronavirus Disease 2019 (COVID-19), the reality is that healthcare employees are currently the most likely to be exposed to the disease in the United States. Accordingly, healthcare employers must start, or continue, to think about the various situations that may arise in the workplace and the multitude of laws that may apply ...

PLMJ | September 2020

Coronavirus Digest no. 4 Patents and other intellectual property rights 1. Patents Moderna reveals that it may not hold the patent rights for the vaccine against Covid-19, because it was not the first to file the patents. This came after the US National Institute of Health claimed co-ownership of the rights to this vaccine. Read more here ...

PLMJ | August 2020

The world is desperately seeking a vaccine and treatments against COVID-19 and the answer will also be found in intellectual property. For this reason, PLMJ and Inventa International have joined forces to prepare a Digest on these issues that is continuously updated ...

Hanson Bridgett LLP | February 2020

Introduction The recent spread of the coronavirus around the world is justifying significant concern among senior living operators and raising questions about how to prepare for and respond to the possibility that the disease will affect residents, staff, and visitors. This concern is exacerbated by the fact that seniors tend to be more vulnerable to such communicable diseases and live in close quarters with others at the community, sharing meals and participating in group activities ...

ALTIUS/Tiberghien | March 2020

EUIPO On 16 March 2020, the Executive Director of the European Union Intellectual Property Office (EUIPO) has issued Decision No EX-20-3 extending all time limits expiring between 9 March 2020 and 30 April 2020, that affect all parties before the Office, to 1 May 2020. In principle, the new deadlines will not be communicated to the parties on a case-by-case basis ...

PLMJ | April 2020

INFARMED has published a set of exceptional measures – which will remain in force during the period of risk to public health – to be adopted by sponsors, clinical trial sites, and research teams, to guarantee the safety, protection and rights of clinical trial subjects.It has also defined INFARMED’s evaluation of trials intended to treat or prevent the new Coronavirus disease (SARS-CoV-2) as a priority ...

PLMJ | April 2020

The rapid spread of the new Coronavirus (SARS-CoV-2) and the Covid-19 pandemic have led to a very significant increase in demand for medical devices (MDs) and personal protective equipment (PPE), and there was insufficient supply to meet existing needs during the state of emergency and the period that will immediately follow it ...

PLMJ | March 2020

On 17 March, the Energy Services Regulator (“ERSE”) approved Regulation 255-A/2020 and it was published in the official gazette, Diário da República, on 18 March 2020 ...

PLMJ | March 2020

A global public health emergency was declared by the World Health Organization on 30 January 2020 as a result of the spread of the new virus COVID-19. The virus was later classified as a pandemic on 11 March 2020. As a result, it is important guard against any negative impact of the events relating to COVID-19 on ongoing energy licensing processes and on the energy market as a whole, particularly in the light of Decree-Law 172/2006 of23 August (“DL 172/2006”) ...

PLMJ | April 2020

INFARMED and the DGS have published a set of guidelines for manufacturers and wholesale distributors of medicinal products for human use. The aim of these guidelines is to ensure supply to the domestic market and, at the same time, to prevent the spread of Covid-19 and protect the employees of these operators ...

PLMJ | February 2021

Following the differences that came to light with AstraZeneca at the end of last week, the European Commission approved Implementing Regulation (EU) 2021/111 of 29 January 2021, which came into force on Saturday, 30 January. The Regulation prohibits the unauthorised exportation of vaccines against SARS-CoV-2 outside the European Union ...

PLMJ | February 2021

Brief notes on Commission Regulation 2021/111 of 29 January 2021 Following the differences that came to light with AstraZeneca at the end of last week, the European Commission approved Implementing Regulation (EU) 2021/111 of 29 January 2021, which came into force on Saturday, 30 January. The Regulation prohibits the unauthorised exportation of vaccines against SARS-CoV-2 outside the European Union ...

Haynes and Boone, LLP | October 2002

The recent accounting frauds and corporate scandals have many in-house counsel, as well as directors and officers, re-examining their responsibilities, obligations, and potential liabilities. New legislation, SEC regulations, stock exchange listing standards and public, media and shareholder scrutiny are imposing new or expanded processes for corporate accountability, financial reporting and business practices ...

Buchalter | May 2021

By: Carol K. Lucas At a time when many are questioning the continued utility and viability of the corporate practice of medicine ban, California may be doubling down. On May 3, 2021, the California Senate Health Committee approved SB-642, the stated purpose of which is to protect medical decision-making from lay control. The bill is currently pending in the California Senate. Assembly Bill AB-705 is a substantially identical bill in the California Assembly ...

Haynes and Boone, LLP | September 2002

Appeared in Lone Star Express, a puclication of the Lone Star Chapter of the Healthcare Financial Management Association, September 2002. The recent reports of corporate fraud, improper accounting practices, and mismanagement have resulted in new legislation and stock exchange standards for publicly-traded corporations. In order to restore confidence in the nation’s financial markets, President George W ...

Dinsmore & Shohl LLP | February 2023

On December 29, 2022, the Modernization of Cosmetics Regulation Act (“MoCRA”) was signed into law.[1] MoCRA is the first federal cosmetics law since 1938 and will impose a number of new requirements on cosmetic products and the facilities where they are manufactured. Specifically, MoCRA requires the Food and Drug Administration (FDA) to implement enhanced oversight and regulation of cosmetic manufacturing facilities and products by December 29, 2023 ...

Waller | July 2020

The use of telehealth skyrocketed during the COVID-19 public health emergency, as many regulatory barriers restricting its use were temporarily removed at the federal and state level and by private payors. Providers and patients adapted to the changes and are now relying on these flexibilities to deliver and receive high quality virtual care. This rapid expansion of the use of telehealth has ignited the need for permanent telehealth reform ...

Dykema | February 2021

The de novo medical device process is a little-used but potentially valuable means of securing approval for your medical device. The pathway was established in 1997 subject to the Federal Food Drug & Cosmetic Act, Section 513 (f) (2). It was designed to employ a risk-based strategy for novel devices that have not yet been classified. Basically, it establishes a new device type including classification, regulation, appropriate controls and product code ...

ALRUD Law Firm | February 2024

The year 2023 was marked by the further strengthening of control over transactions involving the sale of Russian assets owned by “unfriendly” foreign entities, as well as over Russian strategic companies. As for antimonopoly regulation, after several years of discussions and revisions, the fifth antimonopoly package was adopted, and a number of precedent-setting cases were considered. Please see below for more details about the key developments and highlights of 2023. 1 ...

Hanson Bridgett LLP | March 2017

Upon reconsideration in Gerard v. Orange Coast Memorial Medical Center, Case No. G048039 (March 21, 2017) (Gerard II), the Fourth Appellate District decided that IWC Wage Order 5 is valid and that healthcare employees may waive one of their two required meal periods on shifts longer than 8 hours ...

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