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FDA innovates with new guide for drug approval in the United States

December 1, 2023

The American agency Food and Drug Administration (FDA) innovated once again by creating a new guide on real-world evidence (RWE) and real-world data (RWD) to support drug approval.

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Artificial intelligence and its regulation in Brazil

November 22, 2023

On March 29, 2023, “The New York Times” published an article regarding an open letter signed by more than a thousand leaders in the technology sector, including Elon Musk, president of Tesla, Space X, and X (formerly Twitter). The letter requested a stop in the development of artificial intelligence above GPT-4, developed by OpenAI, considering the potential risk of threatening the very existence of society as we know it and even humanity.

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The Fight Against Fake News Around the World

November 14, 2023

The advancement of technology is overwhelming and inevitable. However, while it revolutionizes communication on a global scale, enabling easy access to information and taking progress to previously inaccessible places, it can have the opposite effect, with a hidden purpose perpetrated by those who maliciously convert a lie into a truth. In fact, as Joseph Goebbels, minister of Nazi propaganda, said, “a lie told a thousand times becomes the truth”.

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Everything you need to know about ISO

November 7, 2023

Although the headquarters of the International Organization for Standardization (ISO) is located in Geneva, Switzerland, few people are aware that the organization was founded after a meeting that took place in London, England, in 1946, shortly after the end of the Second World War. At said meeting, 65 representatives from 25 countries sought to discuss the future of international standardization in several areas.

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How to Implement ERM

October 30, 2023

ERM, short for enterprise risk management, plays a fundamental role in identifying, preventing, and managing potential risks that may impact business and influence a company's results, ensuring its long-term viability.

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More Sanctions Applied By The Brazilian Data Protection Authority signal that Violations of the LGPD Will Not Be Tolerated

October 23, 2023

The Brazilian Data Protection Authority (ANPD) published on October 18, 2023 their third sanction for violation of the General Data Protection Act (LGPD). Similarly to the second penalty, the infraction occurred in the public sector, not involving a private company.

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Brazilian Data Protection Authority Applies Second Penalty for Violation of the Data Protection Act

October 16, 2023

After a phase where the Brazilian Data Protection Authority (ANPD) focused on regulating important provisions outlined in the General Data Protection Act (LGPD), in addition to editing several manuals and guidelines to assist the public in complying with the law, the ANPD has imposed its first penalty on July 6, 2023, targeting the company Telekall Infoservice.

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Antitrust and anti-corruption authorities are already monitoring the 2026 World Cup

October 3, 2023

Considering the financial scandals fueled by acts of corruption involving the most recent World Cup, which led to the arrest of leaders from several countries, North American antitrust and anti-corruption authorities turned their attention to the 2026 World Cup, which will take place in three countries: United States, Canada, and Mexico. Among the arrests made, one that stood out was that of José Maria Marín, former president of the Brazilian Football Confederation (CBF) between 2012 and 2015 who was also governor of the State of São Paulo between 1982 and 1983, after the death of governor Franco Montoro.

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Retaliation against non-disclosure agreements in the USA

September 25, 2023

Non-disclosure agreements are used by many companies with the purpose of guaranteeing or, at least, trying to hinder the disclosure of their confidential information by employees or former employees. Some companies require the signing of NDAs alongside the employment contract, while others require the signing of these documents upon termination of the employment contract, occasionally offering a bonus and demanding silence in exchange. If the employee violates the agreement, he or she may be forced to return the amount paid, often with interest and/or fines added.

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SASE and what it can do for information security!

September 11, 2023

To talk about information security or cybersecurity is definitely not the easiest of tasks, as developments in this area seem to be happening at a speed that is difficult to keep up with. The cat-and-mouse race between hackers and information security experts is incessant and at a breathtaking pace. Something that appears to be novel today may already be outdated, because in another corner of the world a more efficient solution may have already been discovered or a flaw in the current solution may have been identified that makes it vulnerable.

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ABOUT US

Licks Attorneys Compliance’s Blog provides regular and insightful updates about Ethic and Compliance. The posts are authored by Alexandre Dalmasso, our partner. Licks Attorneys is a top tier Brazilian law firm, specialized in Intellectual Property and recognized for its success handling large and strategic projects in the country.

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Licks Attorneys' COMPLIANCE Blog

Webinar ‘FCPA Review 2020 – Hot Cases’

On the afternoon of April 8th, the webinar ‘FCPA Review 2020 – Hot Cases’ was presented by partner Alexandre Dalmasso.

Webinar ‘FCPA Review 2020 – Hot Cases’Read Full Article

NEW GOVERNMENT PROCUREMENT RULES ARE ENACTED IN BRAZIL

President Jair Messias Bolsonaro just signed the new Government Procurement Act into law, converting the Bill (PL) 4.253 / 2020 into Law 14.133 of April 1, 2021.

NEW GOVERNMENT PROCUREMENT RULES ARE ENACTED IN BRAZILRead Full Article

THE DISPOSAL OF PERSONAL DATA

Recently, the Federal Supreme Court (STF) positioned itself against the right to be forgotten versus the media's right to report certain facts. In this specific case, the STF ended up endorsing the thesis recognizing a right to be forgotten would be an act of censorship, given the media's right to report news for society's knowledge accurately.

THE DISPOSAL OF PERSONAL DATARead Full Article

CNIL INTRODUCED NEW RULES FOR THE USE OF COOKIES IN FRANCE IN 2020

In October 2020, the Commission Nationale de l’Informatique et des Libertés (CNIL), the French body that regulates the protection of personal data in that country, published two documents, one designated “guidelines” and the other called “recommendations,” establishing rules and good practices, concerning the use of cookies on the internet.

CNIL INTRODUCED NEW RULES FOR THE USE OF COOKIES IN FRANCE IN 2020Read Full Article

AN ANALYSIS OF THE SANCTIONS APPLIED BY THE WORLD BANK IN 2020

The World Bank published its Annual Sanctions Report for 2020, highlighting the institution’s concern with the projects it finances globally and potential risks of fraud and corruption.

AN ANALYSIS OF THE SANCTIONS APPLIED BY THE WORLD BANK IN 2020Read Full Article

THE FRENCH ANTICORRUPTION AGENCY (AFA) PUBLISHES NEW GUIDELINES FOR PUBLIC AND PRIVATE ORGANIZATIONS

On January 12, 2021, the French Anti-Corruption Agency (AFA) published new guidelines for companies in the public and private sectors, laying out recommendations in order to ensure compliance with the French Anti-Corruption Law (Sapin II) sanctioned since the end of 2016.

THE FRENCH ANTICORRUPTION AGENCY (AFA) PUBLISHES NEW GUIDELINES FOR PUBLIC AND PRIVATE ORGANIZATIONSRead Full Article

COMPLIANCE PROGRAM REQUIREMENTS FOR BIDS IN THE STATE OF PERNAMBUCO ARE POSTPONED

Following the states of Rio de Janeiro, Espírito Santo, Santa Catarina, and the Federal District, the State of Pernambuco signed a law that compels the implementation of a compliance program (called an ‘integrity program’ in the public sector) by private companies that wish to contract with the state government. I am referring to State Law 16,722, enacted on December 9, 2019.

COMPLIANCE PROGRAM REQUIREMENTS FOR BIDS IN THE STATE OF PERNAMBUCO ARE POSTPONEDRead Full Article

USFDA PUBLISHES GUIDELINES FOR MANUFACTURERS NAMING NEW MEDICINES

The US Food and Drug Administration (FDA) has just published new guidelines for manufacturers regarding the choice of names for their medicines. The guide focuses on how the trust and distinction of other existing medication may be transmitted to end-users, that is, to patients.

USFDA PUBLISHES GUIDELINES FOR MANUFACTURERS NAMING NEW MEDICINES Read Full Article

Judicialization of medicines: USA x Brazil’

On February 9th, webinar Judicialization of medicines: USA x Brazil’ was presented by partner Alexandre Dalmasso. Dalmasso discussed the access both Brazil and USA have to medicines as well as the legal and financial impact.

Judicialization of medicines: USA x Brazil’ Read Full Article

Statistical results of General Data Protection (GDPR) enforcement in 2020

The year 2020, plagued by the Covid-19 pandemic, has passed. European countries suffered amid the coronavirus's spread, with Italy, Spain, the United Kingdom, and France most negatively affected in the first wave. Subsequently, during the second wave, the United Kingdom and Portugal ended up leading in infection rates and discovering a new yet more contagious strain.

Statistical results of General Data Protection (GDPR) enforcement in 2020Read Full Article

Is there potential for excessive rigor in data protection?

The General Data Protection Law (LGPD), created in 2018, finally came into force in Brazil in 2020. The National Data Protection Agency (ANPD) was structured accordingly to begin managing and controlling the effective protection of personal data. However, to date, the ANPD has not yet started to standardize obscure aspects of the law and address gaps that need regulation.

Is there potential for excessive rigor in data protection?Read Full Article

The ANPD and the challenge of enforcing the LGPD

The recently formed National Data Protection Authority (ANPD) has a challenging mission to standardize or regulate various situations that require more detailed regulation by the primary authority responsible for personal data in Brazil.

The ANPD and the challenge of enforcing the LGPDRead Full Article

How Canada combats spam!

Recently, in an article on this website, the USA’s 2003 CAN-SPAM law that helped regulate spam was mentioned (Sending and Posting Advertisement in Mass, translated into Portuguese as ““Enviar e Postar Publicidade em Massa,” or Stupid Pointless Annoying Messages, which translates into Portuguese as “Mensagens Perturbadoras, Estúpidas e Sem Noção”).

How Canada combats spam!Read Full Article

Can a collection company call indebted consumers once the General Data Protection Law is in force?

Under the General Data Protection Law (LGPD) now in force, a frequently asked question is whether collection companies contracted by financial institutions, retail chains, or other lending organizations can continue to call individuals – allegedly using their personal data shared by the companies which contracted the service and, therefore, creditors of the vindicated amount – or not.

Can a collection company call indebted consumers once the General Data Protection Law is in force?Read Full Article

CONAR launches a guide for digital influencers

The National Council for AdvertisingSelf-Regulation (CONAR) launched the Guide for Digital Influencers in November2020 to establish standards and ethical criteria in advertising to be carriedby the channels used by such influencers.

CONAR launches a guide for digital influencersRead Full Article