Speaker Profile

Anne
Anne Tomalin
President, Therapeutic Products Inc.

Anne Tomalin has practiced exclusively in the area of regulatory affairs since 1971. She has a strong background in business, government, regulations and reimbursement policies.

Anne is a graduate of York University, and holds a B.A. degree in English (1970) and a B.Sc. degree in Chemistry (1980). Anne has received a Regulatory Affairs Certification from the Regulatory Affairs Professional Society for US Regulatory Affairs (1997), European Regulatory Affairs (2001) and Canadian Regulatory Affairs (2005).

Anne founded Therapeutic Products Inc. in September 2013. TPIreg is a Regulatory Affairs boutique firm specializing in Canadian Regulatory Affairs.

Anne founded CanReg Inc. in September 1996. CanReg was acquired by OptumInsight in December 2009. Prior to founding CanReg, Anne was employed for 20 years with Searle Canada, A Unit of Monsanto Canada Inc. as Business Unit Director. Responsibilities in the last several years at Searle included regulatory affairs, provincial government, reimbursement strategies, managed care, customer interface, legal and information services. Prior to joining Searle, Anne was employed by Hoffmann-LaRoche Limited for three years.

Prior to Roche, Anne was employed for three years by Wyeth Ltd. Anne has participated in the Regulatory Initiatives Advisory Committee for the Pharmaceutical Manufacturers Association of Canada (PMAC). She has also served on the executive of the Pharmaceutical Sciences Group (PSG) and the Canadian Association of Pharmaceutical Regulatory Affairs (CAPRA).

In Canada, Anne has also chaired the Manitoba, Saskatchewan and Ontario Committees for the Pharmaceutical Manufacturers Association of Canada (PMAC), now Rx&D, and she has worked with the Nova Scotia Department of Health to revamp their drug formulary. Anne is also engaged in teaching several regulatory courses to industry, including inhouse training courses for several large companies.

Upcoming Webinars Recorded Webinars
Anne Tomalin

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
Anne Tomalin

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
Anne Tomalin

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
Anne Tomalin

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
Anne Tomalin

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
Anne Tomalin

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
Anne Tomalin

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
Anne Tomalin

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
Anne Tomalin

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
Anne Tomalin

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
Anne Tomalin

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
Anne Tomalin

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
Anne Tomalin

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
Anne Tomalin

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
Anne Tomalin

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: $390.00 | View Details
Anne Tomalin

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: $390.00 | View Details
Anne Tomalin

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: $390.00 | View Details
Anne Tomalin

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: $390.00 | View Details