A Summary of International Efforts in Minimizing the Spread of COVID-19

Delsie Braganza

Delsie joined the Focal Point Research team in 2011 and has been an invaluable asset for our clients. With her strong regulatory and quality assurance background, she is able to help clients understand the Canadian and US requirements, set targets to achieve compliance, and attain their goals to get products to market.

Delsie is able to audit facilities, set up and maintain GMP compliant facilities, develop strong quality management systems, and co-ordinate successful Health Canada inspections. In addition to this, Delsie oversees all regulatory compliance reviews and submissions made to Health Canada and the US FDA.

Delsie obtained an Honours Bachelor of Science (Hons. B. Sc.) in Pharmaceutical Chemistry from the University of Toronto, Post-Graduate Certificate in Pharmaceutical Regulatory Affairs and Quality Operations (RAQ) from Seneca College and Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society (RAPS).

When she’s not learning something new, Delsie loves spending time with family, going on road trips or long walks, and swimming.

Jennifer Porter, BA Psychology, MBA – President & CEO

Having started at Focal Point Research in 2011, Jenn has been fully engaged in the company and since day one, has leveraged her MBA and interest in the regulated products industries to grow her passion for the business and services offered.

Jenn has excelled at building on initial conversations with a variety of companies from all industries seeking regulatory and quality assurance services. She has developed strong relationships with each client, offering each one a unique opportunity to have the Focal Point Research team help them develop successful strategies and bring products to market, while ensuring their compliance needs are being fulfilled.

Jenn has not only been a leader internally, but a key contact for all clients and in 2021, Jenn was the obvious choice to lead Focal Point Research into the future as the successor to company founder, Rob Fichtner.

Jennifer balances her career by honouring her wanderlust, spending her leisure time golfing, and enjoying the outdoors with her loving dog.

Recently, information has been provided regarding updates that Health Canada and the U.S. FDA have done in order to aid in the battle against COVID-19. However, other countries have also taken drastic measures to assist with reducing the spread of COVID-19. The information below will outline a summary of the key implementations both Canada and U.S.A. have taken, along with what the EU has done as well.

To begin, the United States has allowed non-traditional drug manufacturers to produce hand sanitizers, with the condition of following FDA guidance and registration procedures. The hope is that these more relaxed measures will allow a greater volume of hand sanitizer production and distribution (a key component in the fight against coronavirus). The United States will also temporarily suspend all domestic routine facility inspections. This will allow for maximum physical distancing, and non-essential personnel to be able to remain at a distance.

The E.U. has also taken steps to aid the community through this troubling time. The European Chemicals Agency has announced their support of EU/EEA authorities in applying exemptions from normal authorization to speed up the process of disinfectants, such as hand sanitizers, during the pandemic. As well, the European Commission presented new temporary guidelines to ensure the continuous flow of goods across E.U. borders. These guidelines include minimizing procedures for checking transport trucks and their drivers to what is necessary.

Finally, Canada has also taken steps in updating their regulatory processes in order to provide ease during this time. Health Canada has streamlined the process for importing non-prescription drugs with the hope of making import of high demand of non-prescription products easier and quicker for consumers. Along the same lines, Health Canada has temporarily allowed exemptions for importing and releasing disinfectant and sanitization products onto the Canadian market by alleviating and reducing the normal authorization and approval procedures for disinfectant and sanitation products.

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA

Emily Campbell

Delsie Braganza

Jennifer Porter, BA Psychology, MBA – President & CEO

A Summary of International Efforts in Minimizing the Spread of COVID-19

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