ICH Training

Trade Agreement: NAFTA / CFTA / FTAs with Peru / Colombia / Panama / Korea Tendering Procedures: Generally only one firm has been invited to bid Non-Competitive Procurement Strategy: Exclusive Rights Comprehensive Land Claim Agreement: No Vendor Name and Address: THE BRIGHAM AND WOMEN'S HOSPITAL, INC. BWH Div. of Global Health Equity 75 Francis Street, Mailcode 300R Boston Massachusetts United States 02115 Nature of Requirements:

ICH Training

Health Canada has committed to training regulators and stakeholders as part of the implementation of the International Council on the Harmonization guidelines E6(R2) and E17, as specified below. The purpose of this Advance Contract Award Notice (ACAN) is to signal the government's intention to award a contract for these services to preselected supplier: The Brigham and Women’s Hospital, Inc. Before awarding a Contract, the government would like to provide other suppliers with the opportunity to demonstrate that they are capable of satisfying the requirements set out in the ACAN, by submitting a statement of capabilities during the posting period.

If other potential suppliers submit a statement of capabilities during the posting period that meet the requirements set out in the ACAN, the government may proceed to a full tendering process on either the government's electronic tendering service or through traditional means, in order to award a contract.

If no other supplier submits, on or before the closing date, a statement of capabilities meeting the requirements set out in the ACAN, a Contract will be awarded to the preselected supplier.

Background

The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center) is a research and policy center focused on addressing the design, conduct, oversight, ethics, and regulatory environment of clinical trials. The MRCT Center acts as a neutral convener, bringing together academia, industry, patients and patient advocacy groups, non-profit organizations, and national regulatory agencies. The MRCT Center’s efforts have contributed to regulatory approaches, bioethical frameworks, pragmatic guidance, training, and tools in their four focus areas: Global Regulatory Engagement, Ethical Frameworks, Transparency, and Training.

Training is one of the core strengths of the MRCT Center. Complementary approaches are employed including in-person dynamic training and on-line training resources. Their training model involves partnering with regulators, academic leaders, or industry partners to identify appropriate topics that are of highest need.

In 2017 and 2018, the MRCT Center hosted two trainings with a focus on the global standards published by the International Council on the Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use that address best practices for the design, conduct, and oversight of clinical trials, including multi-regional clinical trials (MRCTs). The goals of these multi-day training conferences were to build local regulatory capacity in good clinical practices (GCP) and to facilitate review and oversight of MRCTs. The trainings were in-person, interactive, and case-based, facilitated by senior professionals from the European Medicines Agency, Health Canada, Irish Health Products Regulatory Authority, US Food and Drug Administration, Pharmaceuticals and Medical Devices Agency (Japan’s regulatory body), industry partners, and MRCT Center leadership. The MRCT Center has conducted pilot trainings endorsed by ICH (October 2017 training) and the Asia-Pacific Economic Cooperation (APEC) as a Pilot Center of Excellence (April 2018 training). In September of 2018, the MRCT Center was endorsed as an APEC Training Center of Excellence in MRCT and GCP inspection.

Objectives

Health Canada would like to fulfill its commitment of training regulators and stakeholders as part of the implementation of the ICH guidelines by offering training for ICH E6(R2) GCP and ICH E17 MRCT.

The purpose of this training is to build a skilled capacity in Canada on clinical trial regulatory science to:

a) Provide interactive, case-based training, facilitated by senior professionals from Health Canada, the Contractor and international regulatory agencies; b) Facilitate the development, regulatory review and oversight of MRCTs; c) Apply newly updated principles of E6(R2) GCP to the conduct of clinical trials and the regulatory setting; and d) Prepare for and/or conduct focused and thorough GCP inspections.

Target Audience

a) Approximately 60 participants in total, half of the participants would be regulators (principally reviewers and inspectors) from Health Canada and the other half will be other stakeholders (including industry and academia); and b) A larger audience (approximately 80) could be accommodated if there is interest and space allows.

All of the services, with the exception of the training, must be completed at the Contractor’s location. The training must be delivered at 111 Sussex Drive, Ottawa, Ontario, Canada.

Applicability of the Trade Agreements to the Procurement

This procurement is subject to the following trade agreements: the North American Free Trade Agreement (NAFTA) and the Canadian Free Trade Agreement (CFTA).

Justification for the Pre-Identified Supplier

The pre-identified supplier is the only supplier capable of meeting the government’s requirements, because the pre-identified supplier owns the intellectual property rights on all the training materials.

Government Contracts Regulations Exception

The following exception to the Government Contracts Regulations is invoked for this procurement under subsection 6(d) only one person is capable of performing the contract (http://laws-lois.justice.gc.ca/eng/regulations/SOR-87-402/page-2.html#h-6).

Limited Tendering Reasons

The following limited tendering reasons are invoked under

NAFTA - Article 1016, paragraph 2(b) (https://www.nafta-sec-alena.org/Home/Legal-Texts/North-American-Free-Trade-Agreement?mvid=1&secid=a550e516-c181-49fc-9176-76db29b2969b#A1016).

CFTA - Article 513, paragraph 1(b)(ii) (https://www.cfta-alec.ca/wp-content/uploads/2017/06/CFTA-Consolidated-Text-Final-Print-Text-English.pdf).

Ownership of Intellectual Property

Without affecting any existing intellectual property rights or relating to information or data supplied by Canada for purposes of the Contract, copyright in anything conceived, developed, or produced as part of the Work under the Contract will belong to the Contractor.

Period of the Proposed Contract

The proposed contract is from date of Contract to March 31, 2019 inclusive.

Name of the Pre-identified Supplier

The Brigham and Women’s Hospital, Inc.

Suppliers' Right to Submit a Statement of Capabilities

Suppliers who consider themselves fully qualified and available to provide the services described in the ACAN may submit a statement of capabilities in writing by e-mail, as an attachment, in either Microsoft Word or Portable Document Format (PDF) to the contact person identified in this notice on or before the closing date of this notice. The statement of capabilities must clearly demonstrate how the supplier meets the advertised requirements.

Closing Date for a Submission of a Statement of Capabilities

The closing date and time for accepting statements of capabilities is December 14, 2018 at 2:00 p.m. Eastern Standard Time.

Inquiries and Submission of Statements of Capabilities

Inquiries and statements of capabilities are to be directed to

Diane Reynolds Supply Specialist Public Works and Government Services Canada Acquisitions Branch Professional Services Procurement Directorate Terrasses de la Chaudière 10 Wellington, 5th Floor Gatineau, Quebec, K1A OS5 Telephone: 613-858-8571 Facsimile: 819-956-2675 E-mail: Diane.Reynolds@tpsgc-pwgsc.gc.ca

Delivery Date: Above-mentioned

You are hereby notified that the government intends to negotiate with one firm only as identified above. Should you have any questions concerning this requirement, contact the contracting officer identified above.

An Advance Contract Award Notice (ACAN) allows departments and agencies to post a notice, for no less than fifteen (15) calendar days, indicating to the supplier community that it intends to award a good, service or construction contract to a pre-identified contractor. If no other supplier submits, on or before the closing date, a Statement of Capabilities that meets the requirements set out in the ACAN, the contracting authority may then proceed with the award. However, should a Statement of Capabilities be found to meet the requirements set out in the ACAN, then the contracting authority will proceed to a full tendering process.

Suppliers who consider themselves fully qualified and available to provide the services/goods described herein, may submit a statement of capabilities in writing to the contact person identified in this Notice on or before the closing date of this Notice. The statement of capabilities must clearly demonstrate how the supplier meets the advertised requirements.

The PWGSC file number, the contracting officer's name and the closing date of the ACAN must appear on the outside of the envelope in block letters or, in the case of a facsimile transmission, on the covering page.

The Crown retains the right to negotiate with suppliers on any procurement.

Documents may be submitted in either official language of Canada.