N2 News

Webinar: Identifying Best Practices for Conducting Clinical Trials with the New FDA Guidance During the COVID-19 Pandemic

N2 members this message is courtesy of the Clinical Trials Transformation Initiative, who are hosting a webinar to identify best practices for conducting clinical trials with the new FDA guidance during the Covid-19 pandemic.

This week, stakeholders from across the clinical trials ecosystem submitted experiences and insights related to the FDA’s new guidance on the conduct of clinical trials of medical products during the current COVID-19 pandemic. The Clinical Trials Transformation Initiative (CTTI) collated the feedback – including insights on safety considerations, remote study visits, remote consent, consulting with IRBs, and more – and will share the findings and best practices via a webinar on Tuesday, March 31 at 11:15 a.m. EST.

M. Khair ElZarrad, FDA, CDER, will provide opening comments and a full discussion on the findings, along with detailed examples of best practices, will be presented by:

  • David Borasky, WCG
  • Sara Calvert, CTTI
  • Cindy Geoghegan, Individual Patient Representative/Caregiver
  • Colleen Rouse, Cleveland Clinic
  • Pamela Tenaerts, CTTI
By exchanging best practices and insights, we can continue our important work to develop needed medical products during this situation, and perhaps even glean some opportunities to do clinical trials better, now and in the future.

Click here to register for the webinar

Notice: Expedited Review of Health Product Submissions and Applications to address COVID-19

Date: March 18, 2020
Our file number: 20-104980-839

On March 18, 2020, the Minister of Health approved an Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19. The interim order will enable an expedited review of medical devices indicated to diagnose, treat, mitigate or prevent COVID-19, at no cost.

COVID-19 is a new disease not previously identified in humans. Currently there is no vaccine or therapeutic product for COVID-19 that is authorized to treat or prevent the disease. The outbreak of COVID-19 has resulted in a global review of therapies that could be used to treat or prevent the infection.

Prior to a product being available on the Canadian market, Health Canada reviews product information to confirm the requirements of the Food and Drugs Act (FDA) and its associated regulations are met. Based on the information provided, the Department assesses the risks and benefits of the product to ensure Canadians have access to products that are safe, effective and of quality.

In an effort to facilitate earlier access to a vaccine, or therapeutic product for COVID-19, the Department will expedite the review of any COVID-19 related health product submissions and applications. Doing this will ensure timely access to novel therapies without compromising the safety, efficacy and quality of products.

As there are no existing therapies or vaccines to effectively treat or prevent COVID 19, there is an urgent need to get novel therapies into clinical trials. This will allow research in Canada of these novel therapies and provide Canadians access to new investigational therapies aimed at preventing or treating COVID-19. Clinical trials ensure the gathering of information to support the safety and efficacy of the product while allowing access under controlled circumstances. When such trials have sufficient evidence to support full market authorization, Health Canada will work with sponsors to expedite the development and authorization of these products. When expediting the review of submissions and applications with the goal of enabling timely access to vaccines and therapeutic products, Health Canada will continue to ensure products are supported by sufficient evidence of safety, efficacy and quality to merit access to Canadians.

Until a vaccine or therapeutic product is available on the Canadian market, Health Canada’s Special Access Programs for Drugs and Medical Devices are available to practitioners or healthcare professionals requiring access to drugs that provide supportive treatments to the infection, or diagnostic devices to identify COVID-19 in patients.

Sponsors wishing to file a submission or application should contact the appropriate review bureau.

Review Bureau Contact Information

Biologic and Radiopharmaceutical Drugs Directorate

Office of Regulatory Affairs
Tel: 613-957-1722
Fax: 613-946-9520
E-mail: hc.brdd.ora.sc@canada.ca

Therapeutic Products Directorate:

Bureau of Gastroenterology, Infection and Viral Diseases
Telephone: 613-941-2566
Fax: 613-941-1183
E-mail: hc.bgivd.enquiries.sc@canada.ca

Submission Management Division, Office of Clinical Trials
Fax: 613-946-7996
E-mail: hc.oct_bec_enquiries.sc@canada.ca

Special Access Programme – drugs
Telephone: 613-941-2108
Fax: 613-941-3194
E-mail: hc.sapd-pasm.sc@canada.ca

Natural and Non-prescription Health Products Directorate (NNHPD)

Regulatory Project Management Unit, servicing Non-prescription Drug Evaluation Division
Fax: 613-946-9614
Telephone: 613-946-9315
Telephone: 613-957-6801 for the Regulatory Project Management Unit
Email: hc.nnhpd-dpsnso.sc@canada.ca

Medical Device Directorate:

Bureau of Device Licensing Services
Email: hc.devicelicensing-homologationinstruments.sc@canada.ca.

Investigational Testing
Telephone: 613-941-4308
E-mail: hc.it-ee.sc@canada.ca

Special Access Program – Medical Devices
Tel: 613-946-8711
Fax: 613-957-1596
E-mail: hc.sap.devices.mdb.sc@canada.ca

Welcome to the Board!

N2 would like to welcome our newest Board Member, Lisa Johnston! Lisa graduated from Laurentian University with a nursing degree and is a SOCRA certified clinical research professional. Among other roles, Lisa was a clinical research coordinator for over ten years, and since 2007 has been involved in training, education, and support in research at UHN, CAMH, and the Ottawa Hospital Research Institute (OHRI). She is currently a Clinical Research Facilitator at the Ottawa Hospital Research Institute.

Lisa is an active member of the N2 Education Committee since 2008. She is the GCP lead for CITI Canada and is currently the Chair of the Education Committee.

While we are excited to have a new Board Member, we are also saying goodbye to two of our long-term Board Members, Nancy Camack and Scott Corley. Nancy is the Director at the OHRI, and Scott is the Director of the Clinical Trial Support Unit at Saskatchewan Centre for Patient-Oriented Research (SCPOR). We want to thank Nancy and Scott for all their hard work and dedication over the years with N2 and wish them the very best in the future.