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The FDA unifies Premarket Review for Combination Products

May 23, 2022

In January 2022, the Food and Drug Administration (FDA) published an interesting guide, called Principles of Premarket Pathways for Combination Products, which establishes the unification of premarket review of combination products.

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Advances in Telemedicine Regulation in Brazil

May 16, 2022

Up until now, telemedicine in Brazil had been regulated by Law 13,989 of April 15, 2020, which provided for the use of telemedicine during the crisis caused by the coronavirus (SARS-COV-2). That is, apparently there was only regulation approved in Congress, after the country faced a national emergency, because of the pandemic that was expanding and causing deaths and sequelae wherever it arrived, forcing social isolation. In fact, social isolation was the driving force for services, such as those resulting from the use of telemedicine.

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FCPA 2021 Review - Hot Cases

May 9, 2022

For this week's Licks Attorneys Compliance Blog, we will re-air the webinar “FCPA Review 2021 – Hot Cases”, hosted by our partner Alexandre Dalmasso.

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Does doing the right thing deserve recognition?

May 2, 2022

Successful compliance programs typically take place in organizations with examples coming from the top. There is no doubt about the fundamental factor for success in such programs: top management engagement, or a culture of example. There is no way for a compliance program to prosper otherwise.

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How to Protect Your Personal Data

April 25, 2022

On August 14, 2018, the Brazilian General Data Protection Act (LGPD) – Statute #13,709 established general rules for the protection of every individual's personal data – something that, until then, lacked safeguards and limits on third-party use.

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Lessons in Drug Promotion by the FDA

April 18, 2022

The Food and Drug Administration (FDA) is the American agency responsible for protecting and promoting public health through the control and supervision of food safety, medicines and the like, a role similar to that performed by ANVISA in Brazil.

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Changes to Legislation of the Brazilian Public Healthcare System (SUS) Bring Hope to Patients

April 11, 2022

One of the greatest Brazilian achievements is undoubtedly the Brazilian Public Healthcare System (SUS). Provided for by Article 196 of the 1988 Brazilian Constitution, it establishes that health is a right for all and a duty of the State, and guarantees to every Brazilian access to public health, regardless of payment to the Brazilian Social-Security Administration (INSS).

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Interfarma updates its Code of Conduct

April 4, 2022

We have recently published two posts regarding the update made to the codes of PhRMA (Pharmaceutical Research and Manufacturers of America) and the IMC (Innovative Medicines Canada).

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Innovative Medicines Canada (IMC) updates its Code of Ethical Practices

March 27, 2022

The Innovative Medicines Canada (IMC) was founded on April 23, 1914, by representatives of 10 pharmaceutical and toilet products companies under the name “Canadian Association of Manufacturers of Medicinal and Toilet Products”. In 1915, the association changed its name to “Canadian Pharmaceutical Manufacturers Association”, while in 1965, the association again changed its name to the “Pharmaceutical Manufacturers Association of Canada (PMAC)”.

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How are whistleblowers treated in Europe?

March 21, 2022

Since 2010, with the enactment of the "Dodd-Frank Act", the United States introduced the whistleblower, i.e., someone who witnesses an irregularity within the following parameters:

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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

BE LOYAL TO THE COMPANY OR BE LOYAL TO THE BOSS

Regardless of whether an employee is hired under an employment contract or just by signing in the employment and social security card, his / her initial duty of loyalty to the company is not challenged, which after all, pays his / her compensation for their services and waits in return for his / her commitment to the development of the corporation's business.

BE LOYAL TO THE COMPANY OR BE LOYAL TO THE BOSSRead Full Article

Compliance Investigation

On the afternoon of April 15th, a webinar was held with the topic "Compliance Investigation", led by Alexandre Dalmasso, partner and responsible for the Ethics and Compliance Practice Group. The webinar aims to discuss the best practices and main challenges for successful compliance investigations, unraveling the investigation phases, identifying gaps in the process and how to implement improvements based on the results obtained.

Compliance InvestigationRead Full Article

EXCELLENCE IN THE CODE OF CONDUCT

At the beginning of the millennium, when the so-called 1st compliance wave occurred, a document started to gain evidence: the Code of Conduct.

EXCELLENCE IN THE CODE OF CONDUCTRead Full Article

MISCONDUCT – INHERITED OR MOLDED CHARACTER TRAITS

Some time ago, I came across an unusual situation ... there was a company that allowed its employees to use a taxi as a mean of transportation due to some need related to the company's business. There were no major controls and, oddly enough, a receipt from the taxi was not even required for accountability.

MISCONDUCT  – INHERITED OR MOLDED CHARACTER TRAITSRead Full Article

In the fight against corruption, who is who in the world...

Although several governments are striving to combat and mitigate corruption and its consequences, since talking about eradicating corruption is an almost utopian task, it is important to know the world´s players in this fight.

In the fight against corruption, who is who in the world...Read Full Article

Corruption Perceptions Index 2019

Corruption Perceptions Index or simply CPI is an index created by a non-governmental organization named Transparency International (www.transparency.org), which, among other purposes, has set out to monitor countries' progress in fighting corruption around the world.

Corruption Perceptions Index 2019Read Full Article

Red Flags

Red flags mean situations that deserve special attention and that must be carefully observed by managers and, mandatorily, by compliance officers and auditors. In short, they are warning signs, which should not and cannot be ignored.

Red FlagsRead Full Article

How to proceed when paying something to a Government official?

This is certainly a question that concerns many managers and even many compliance officers or even those responsible for providing guidance within an organization.

How to proceed when paying something to a Government official?Read Full Article

Critical Points in the process of adapting of LGPD

On the afternoon of February 19th, 2020, a webinar was held with the topic "Critical Points in the LGDP Suitability Process". Speakers of the webinar were: Alexandre Dalmasso, responsible for the Compliance area and lawyer Douglas Leite, our data privacy leader. The speakers used their experience in LGPD compliance projects to draw the audience's attention to the critical success factors in implementing a similar project.

Critical Points in the process of adapting of LGPDRead Full Article

How all start

My name is Alexandre Dalmasso,  I have a law degree specializing in compliance. I started to interact with issues related to ethics and compliance in 2002, but only in 2005 is when I started to work totally dedicated to the topic. In Brazil, the topic called the attention of countless professionals over the past few years with the rampant growth of several training and certification courses, which is a great indicator for a country that has been trying to get rid of the taint of corruption in order to allow the sustained growth of the economy and foster the increase in employment and entrepreneurship opportunities.

How all startRead Full Article