Covid-19

Submit your COVID-19 related questions for Health Canada by Friday!

To make sure the questions relate to COVID-19 and not the Guide 100 or other Health Canada issues on COVID-19 questions already addressed by the COVID-19 guide, Health Canada would like us to collect questions in advance. We have not received any questions to date, so to ensure Health Canada feels that their time will be of good use, we are encouraging registrants to provide questions. 
Please click here to submit a question, or please feel free to reach out to shelley.king@n2canada.ca to provide questions. Please submit questions by May 15, 2020, by end-of-business day. 

 

Questions for Health Canada related to COVID-19

The N2 May Stakeholder Meeting is May 25, 2020

2:00-3:00 PM EST

Register Here

We are excited that Health Canada will be presenting material related to COVID-19 during the meeting. However, they will only touch on highlights from the Health Canada COVID-19 guide and spend the rest of the time, answering questions from the attendees. 

To make sure the questions relate to COVID-19 and not the Guide 100 or other Health Canada issues on COVID-19 questions already addressed by the COVID-19 guide, Health Canada would like us to collect questions in advance. We have not received any questions to date, so to ensure Health Canada feels that their time will be of good use, we are encouraging registrants to provide questions. 
Please click here to submit a question, or please feel free to reach out to shelley.king@n2canada.ca to provide questions. Please submit questions by May 15, 2020, by end-of-business day. 

 

Register for the N2 May Stakeholder Meeting featuring Health Canada

N2 May Stakeholder Meeting

May 25, 2020

2:00 – 3:00 PM EST

Register Here

In our planning for the next stakeholder meeting, we figured there would be interest in hearing from Health Canada on how COVID-19 impacts things such as regulations, compliance, CTA applications, and reviews. As you know, Health Canada prepared a guide to deal with some questions which we circulated recently. But there is likely more uncertainty out there which they can help us.

We are pleased to inform you that we have just heard back from Health Canada, and they have confirmed their willingness to attend the stakeholder meeting on May 25th.

Presumably, you are familiar with the Health Canada COVID-19 guide, and as such, they will only touch on the highlights from the guide, and then spend the rest of the meeting answering your questions. To make sure the questions relate to COVID-19 and not the Guide 100 or other Health Canada issues on COVID-19 questions already addressed by the COVID-19 guide, they would like us to collect questions in advance.

To make good use of their time and ensure the questions are not already addressed in the guide, we will review the questions and send them to Health Canada before the meeting.

Therefore we are giving you a deadline: Please have your questions into us by May 15th end-of-business day to Shelley at shelley.king@n2canada.ca

There will also be some time to ask questions during the webinar.

If you have any questions, please let us know.

It should be a useful meeting, so make sure to mark your calendar! We are looking forward to “seeing” you at the meeting.

Provide Feedback to CTTI’s Draft Master Protocol Resources

Amid the COVID-19 pandemic, the value of master protocol studies has become clear: we need agile clinical trials that foster collaboration to address major public health threats and ongoing research challenges. You are invited to review and provide comments on draft resources created by the Clinical Trials Transformation Initiative (CTTI) to help drive the appropriate use of master protocols in diverse therapeutic areas. The resources include:

• Master protocols roadmap
• FDA engagement tool
• Business & operations plan template
• Protocol development template
• Vendor assessment tool

Click here to Provide Comments

As an important member of the clinical trials ecosystem, your feedback is important – please suggest revisions or additions to our draft resources by next Friday, April 24 at 11:59 p.m. ET. Your feedback will help shape the final materials that we make available to the public this summer.

Other important information:
• The open comment opportunity is only available in English.
• You may provide comments as an individual or an organization.
• There is no compensation.

COVID-19 Resources

We hope that you and your family are safe during this unprecedented time. N2 is collecting resources and information available related to COVID-19 and in particular clinical research. If you have any resources you would like to share with our larger N2 network please feel free to reach out to us at n2@n2canada.ca. We will continue to provide newsflashes with information as it becomes available.

Health Canada

Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors

FDA

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic (Guidance for Industry, Investigators, and Institutional Review Board)

HealthCareCAN

HealthCareCAN’s free member job postings now available until the end of April to all Canadian hospitals & research institutes