Keeping ahead of the regulatory curve – Stay open for business

June 3, 2020

By: Phil Crooker, VP - Technical, Regulatory Consulting Services, Parexel

On April 21, 2020, a proposed piece of legislation was introduced in the U.S. House of Representatives. The proposed bill is titled “COVID-19 Every Worker Protection Act of 2020” and is identified as H.R. 6559. You can find information about the bill here - https://www.congress.gov/bill/116th-congress/house-bill/6559/text.

This bill would require the Department of Labor to develop and publish both an emergency temporary occupational safety or health standard and a permanent standard to protect certain employees from occupational exposure to the coronavirus (i.e., the virus that causes COVID-19). These standards would apply to health care sector employees, paramedic and emergency medical services employees, and other employees identified as having an elevated risk for exposure. Further, the Centers for Disease Control and Prevention must collect and make public information regarding employee exposure in these occupations and provide guidance to further protect such employees.

The legislation would require that companies who are working in sectors of the economy which have elevated risk for exposure develop and implement a comprehensive infectious disease exposure control plan, with the input and involvement of employees or, where applicable, the representatives of employees, as appropriate, to address the risk of occupational exposure.

As various states begin to implement plans to launch their economies and bring business back on-line, and legislation like this proposed bill and others become part of the puzzle, there are bound to be myriad questions about how to manage workplace safety and operating environments. Parexel recently unveiled its COVID-19 Risk Mitigation offering called “Open for Business”. Our regulatory experts will partner with companies to ensure business continuity during these challenging times by rigorously analyzing business operations to reduce the risk of viral contamination. This will be accomplished through a fully customizable four-step process, including risk assessment, solution framework development, , implementation of solutions and continuity & refinement of the plan to ensure companies are supported over time and as circumstances change or new risks arise.

Parexel’s experts bring first-hand experience in mitigating viral transmission cross contamination gained from decades of experience at global health authorities, including MHRA’s Inspection, Enforcement and Standards Division and FDA/CDER’s Office of Pharmaceutical Quality, Office of Process and Facilities. Our rapid response teams have worked on global public health crises including viral outbreaks (such as SARS, H1N1, MERS and Ebola). The company’s integrated Regulatory & Access team encompasses more than 1,000 on-staff consultants worldwide, including 80+ former regulators and inspectors who have extensive knowledge of and expertise with the GxP, CMC and cGMP review and inspections that companies must navigate successfully to ensure new therapies reach the patients who need them.

For more information about Parexel’s COVID-19 Risk Assessment Offering as well as insights from regulatory and health authority experts, visit Parexel’s COVID-19 Resource Center.

 

 

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