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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

And how about the privacy and protection of personal data in the United States of America?

In this unique year of 2020, the significant milestone in the area of privacy and protection of personal data in the United States of America (USA) remains undoubtedly the CCPA - California Consumer Privacy Act, which started to protect the citizens of the State of California against commercial use of their personal data without their consent. But does privacy and protection of personal data in the US come down to the CCPA only?

And how about the privacy and protection of personal data in the United States of America?Read Full Article

São Paulo State Government prohibits pharmacies and drugstores from requiring a CPF to grant discounts to their customers

The Governor of the State of São Paulo, João Agripino da Costa Doria Junior – better known as João Doria – sanctioned State Bill # 1212/2019 on December 1, 2020. The bill was authored by State Deputy Alex de Madureira as he is known, since his name is Alexander Muniz de Oliveira, being born in Piracicaba, SP, and affiliated with the Social Democratic Party (PSD).

São Paulo State Government prohibits pharmacies and drugstores from requiring a CPF to grant discounts to their customersRead Full Article

The right of the subject to access their personal data and the nightmare this creates for businesses

The General Data Protection Law (LGPD) – Law 13.709 / 2018 – was designed to standardize the protection of personal data handled by third parties (individuals, companies, or the government) for commercial purposes.

The right of the subject to access their personal data and the nightmare this creates for businessesRead Full Article

Drugmaker launches litigation against the US government to enable co-payments

According to Reuters, Pfizer Inc. filed a lawsuit on June 26, 2020, to make it possible to help beneficiaries of the federal healthcare program - Medicare - pay for two drugs to treat a rare and sometimes fatal heart disease, and that cost $225,000 a year.

Drugmaker launches litigation against the US government to enable co-paymentsRead Full Article

Corruption and the criminal liability of companies

Corruption is a topic that always attracts the attention of the media and society.  In some ways, it resembles a kind of metastatic societal cancer, in which a cell released into the bloodstream may burst like a new tumor, anytime, anywhere.

Corruption and the criminal liability of companiesRead Full Article

ABNT Security Certification Diverges from the European Authority's Position on Privacy and Data Protection

A TV commercial recently broadcast to promote a vehicle hire application informed viewers that it was the first and only company in the sector security certified by the Brazilian Association of Technical Standards (ABNT).

ABNT Security Certification Diverges from the European Authority's Position on Privacy and Data ProtectionRead Full Article

Risk assessment - Is yours up to date?

Is your risk assessment up to date?  This is a question that should regularly be asked within any financial institution.  Unfortunately, in most cases, the answer is postponed or even ignored, up until the moment when a government agent needs to evaluate that company's compliance program.

Risk assessment - Is yours up to date?Read Full Article

United States government announces largest healthcare and opioid enforcement action in history

The US Department of Justice (USDOJ) announced a historic nationwide enforcement action against healthcare fraud.  This unprecedented initiative involves 345 charged defendants in 51 federal districts, including more than 100 doctors, nurses, and other licensed medical professionals.

United States government announces largest healthcare and opioid enforcement action in historyRead Full Article

Compliance in the financial market

Ordinance BACEN 3,978 of January 23, 2020, which was created for the purpose of regulating the policy, procedures and internal controls to be adopted by institutions authorized to operate by the Central Bank of Brazil (BACEN) with a view to preventing the use of financial system for the practice of crimes of “laundering” or concealment of assets, rights and values, as set out in Law 9,613, of March 3, 1998, and of terrorism financing, provided for in Law 13,260, of December 16, March 2016, would come into force on July 1, 2020. However, Ordinance BACEN 4,005, dated April 16, 2020, changed the effective date to October 1, 2020.

Compliance in the financial marketRead Full Article

The role of the European Union's Data Protection Officer (Encarregado)

The position of ‘Data Protection Officer’ – established initially under the terms of the EU’s General Data Protection Regulation (GDPR) – has been imported into Brazil’s equivalent General Data Protection Law (LGDP) with the slightly peculiar title of  “Encarregado.”

The role of the European Union's Data Protection Officer (Encarregado)Read Full Article

Rules to protect whistleblowers in the European Union

In April 2018, the European Union launched a proposal to create a Directive standardizing whistleblower protection rules and clarifying the proper protection to be given to those reporting a company's misconduct.

Rules to protect whistleblowers in the European UnionRead Full Article

The concept of the foreign public official under the Usa's Foreign Corrupt Practices Act

The definition of the 'foreign public official,' according to the USA's anti-corruption law – the Foreign Corrupt Practices Act (FCPA) – has always been a sui generis aspect of the regulation, considering its breadth in comparison with similar standards in other countries.

The concept of the foreign public official under the Usa's Foreign Corrupt Practices ActRead Full Article

The principles of the General Data Protection Law - LGDP

The General Data Protection Law (LGPD), Law 13,709 of August 14, 2018, was enacted after the president's sanction, on September 18, 2020,  converting the Provisional Measure 959/2020 into law, and regulating the protection of personal data of individuals, with a level of detail never before achieved by any other local law.

The principles of the General Data Protection Law - LGDPRead Full Article

FCPA Review 2019

On the afternoon of August 27th, webinar ‘FCPA Review 2019’ was presented by partner Alexandre Dalmasso.

FCPA Review 2019Read Full Article