FDA Perspective on International Clinical Trials: US, EU and Canada
This course will provide an overview of the regulatory requirements to conduct clinical trials in Europe, the US and Canada. Data that is required to be filed and the process for approval of the trial will be reviewed.
Speaker: Anne Tomalin | View Anytime | Price: ¤190.00 | View Details
Current Status of Biosimilars in US, Europe and Canada
Biosimilars in the US, including new regulations, existing guidelines, direction from Congress, meetings with the FDA, INDs that have been filed and NDAs that have been filed. We will also discuss the current state of affairs in Canada, who seems to be closely aligning itself with Europe.
Speaker: Anne Tomalin | View Anytime | Price: ¤190.00 | View Details
Clinical Trials in US, Europe and Canada
This presentation will clarify the confusion and illuminate the various requirements across the United States, Europe and Canada.
Speaker: Anne Tomalin | View Anytime | Price: ¤190.00 | View Details
Conducting Observational Studies in US, Canada and Europe
This presentation will clarify the confusion and illuminate the various requirements across the United States, Europe and Canada.
Speaker: Anne Tomalin | View Anytime | Price: ¤190.00 | View Details
Current Status of biosimilars in US, Europe and Canada
Biosimilars in the US, including new regulations, existing guidelines, direction from Congress, meetings with the FDA, INDs that have been filed and NDAs that have been filed. We will also discuss the current state of affairs in Canada, who seems to be closely aligning itself with Europe.
Speaker: Anne Tomalin | View Anytime | Price: ¤190.00 | View Details
Clinical Trial Applications in Canada, and Comparison to the US and Europe
This topic will cover the regulatory submission required in Canada (Clinical Trial Application) and comparison to Clinical Trial Applications in Europe and Investigational New Drug Submissions in the EU. Also covered will be the submission of documentation to Institutional Review Boards, the membership of these boards, and common findings of deficiencies for such Boards. Again, a comparison will be made to the US and EU.
Speaker: Anne Tomalin | View Anytime | Price: ¤190.00 | View Details
Current Status of Biosimilars in US, Europe and Canada
Biosimilars in the US, including new regulations, existing guidelines, direction from Congress, meetings with the FDA, INDs that have been filed and NDAs that have been filed. We will also discuss the current state of affairs in Canada, who seems to be closely aligning itself with Europe.
Speaker: Anne Tomalin | View Anytime | Price: ¤189.00 | View Details
International Regulatory Cooperation Among Agencies
It will also review how agreements are being developed to allow the disclosure of confidential information and discussion of decisions being made. Examples of shared experiences with orphan drugs, cough and cold medications, generic drugs and GMP inspections.
Speaker: Anne Tomalin | View Anytime | Price: ¤189.00 | View Details
Clinical Trial Applications in Canada, and Comparison to the US and Europe
This topic will cover the regulatory submission required in Canada (Clinical Trial Application) and comparison to Clinical Trial Applications in Europe and Investigational New Drug Submissions in the EU. Also covered will be the submission of documentation to Institutional Review Boards, the membership of these boards, and common findings of deficiencies for such Boards. Again, a comparison will be made to the US and EU.
Speaker: Anne Tomalin | View Anytime | Price: ¤127.00 | View Details
Conducting Observational Studies in US, Canada and Europe
This presentation will clarify the confusion and illuminate the various requirements across the United States, Europe and Canada.
Speaker: Anne Tomalin | View Anytime | Price: ¤126.00 | View Details
Clinical Trials in US, Europe and Canada
This course will provide an overview of the regulatory requirements to conduct clinical trials in Europe, the US and Canada. Data that is required to be filed and the process for approval of the trial will be reviewed.
Speaker: Anne Tomalin | View Anytime | Price: ¤127.00 | View Details
International Regulatory Cooperation Among Agencies
This presentation will review what we know of how regulatory agencies are working together internationally to share best practices in reviewing drugs. It will also review how agreements are being developed to allow the disclosure of confidential information and discussion of decisions being made.
Speaker: Anne Tomalin | View Anytime | Price: ¤189.00 | View Details
Clinical Trials in US, Europe and Canada
This course will provide an overview of the regulatory requirements to conduct clinical trials in Europe, the US and Canada. Data that is required to be filed and the process for approval of the trial will be reviewed.
Speaker: Anne Tomalin | View Anytime | Price: ¤189.00 | View Details
Conducting Observational Studies in US, Canada and Europe
This presentation will clarify the confusion and illuminate the various requirements across the United States, Europe and Canada.
Speaker: Anne Tomalin | View Anytime | Price: ¤189.00 | View Details