Development and delivery of a revised HPFB Scientific Writing within Health Canada’s Regulatory Framework Workshop.

Advance Contract Award Notice (ACAN)

Title:

Development and delivery of a revised HPFB Scientific Writing within Health Canada’s Regulatory Framework Workshop.

Solicitation Number: 1000175194

1. The Purpose and Explanation of an ACAN

An Advance Contract Award Notice (ACAN) allows Health Canada to post a notice for no less than fifteen (15) calendar days, indicating to the supplier community that a goods, services or construction contract will be awarded to a pre-identified contractor. If no other supplier submits, on or before the closing date, a Statement of Capabilities that meets the minimum requirements identified in the ACAN, the Contracting Authority may then proceed to award a contract to the pre-identified contractor.

2. Rights of Suppliers

Suppliers who consider themselves fully qualified and available to provide the services or goods described in this ACAN may submit a Statement of Capabilities demonstrating how they meet the advertised requirement. This Statement of Capabilities must be provided via e-mail only to the contact person identified in Section 12 of the Notice on or before the closing date and time of the Notice. If the Bidder can clearly demonstrate they possess the required capabilities, the requirement will be opened to electronic or traditional bidding processes.

3. Proposed Contractor

Global Knowledge Network (Canada) Inc.

360 Albert Street, Suite 720

Ottawa, Ontario

K1R 7X7

4. Definition of Requirements or Expected Results

The Health Products and Food Branch (HPFB) is revising its competency-based training in line with a review of Branch needs and the Organizational Review of the Regulatory Evaluation of Human Therapeutic Products initiative (OREHTP). As part of this initiative, Common and Scientific & Technical competencies for Scientific and Regulatory Reviewers are being reviewed.

One of the key competencies that remains is Scientific Written Communication which is defined as “the ability to communicate effectively in writing with colleagues, subordinates, superiors, clients, and stakeholders”.

The complex scientific and regulatory nature of the written communications prepared by HPFB reviewers presents a training challenge as there are no commercially available scientific writing courses which target the specific learning outcomes required by the review community.

The previously created workshop was designed to meet the requirements of drug, medical devices, health products reviewers in light of the review process in place. The contract will seek to revise the current workshop to include not only current theories of good science writing practices (based on consensus of advice found in today’s science-writing style guides and text books) but also the specific needs of the Branch.

The objectives are as follows:

Phase I

• With HPFB subject matter experts, the contractor will identify the current scientific writing training requirements for the scientific and regulatory community to ensure workshop meets the Branch needs.

• Work with and integrate recommendations from HPFB Scientific and Regulatory Learning Services (SRLS) and subject matter experts.

• Develop and validate a revised instruction plan, including all relevant course content and exercises, based on the recommendations and identified training needs.

• Deliver and assess the 2 day updated scientific writing workshop to ensure alignment with new requirements.
• Revise course instructional plan and all content/exercises based on feedback, where required.

Phase II

• Deliver the updated 2 day scientific writing workshops to HPFB staff, based on needs.

• Provide workshops evaluation and proposed continuous improvement, where applicable.

• The contractor will provide a suitable reference book to all workshop participants.

5. Minimum Requirements

Any interested supplier must demonstrate by way of a Statement of Capabilities that it meets the following minimum requirements:

The provider must have a minimum of five (5) years of experience in:

1. Developing workshops and delivery of effective scientific writing to Scientific and Regulatory staff i.e. drugs, medical devices and health product reviewers.
2. Delivering training workshops in writing practice style and minimal lecture style.
3. Review and evaluation of scientific articles.
4. Knowledge of current theories of good science writing practices
5. Understanding and communicating risks involved in ineffective, poor quality scientific/review
6. Use of adult learning principles to ensure participants are engaged and interested in the workshop and that they have ample opportunity to practice the skills presented.
7. And must have a training facility within the National Capital region with interactive, computer assisted applications.

6. Reason for Non-Competitive Award

The proposed contractor is uniquely specialized in the subject matter in addition to a computer-based training facility to accommodate the delivery of the two-day workshop, Global Knowledge has exclusive ownership and rights of the Intellectual Property

7. Applicable trade Agreements and Justification for Limited Tendering or the Procurement Strategy for Aboriginal Business

Section 6 of the Government Contracts Regulations contains four exceptions that permit the contracting authority to set aside the requirement to solicit bids. These are:

(d) Only One Person or Firm is capable of performing the contract.

Article 506 Paragraph 12 (a) of the Agreement on Internal Trade (AIT) : to ensure compatibility with existing products, to recognize exclusive rights, such as exclusive licences, copyright and patent rights, or to maintain specialized products that must be maintained by the manufacturer or its representative;

Article 506 Paragraph 12 (b) of the Agreement on Internal Trade (AIT) : where there is an absence of competition for technical reasons and the goods or services can be supplied only by a particular supplier and no alternative or substitute exists;

Article 1016 2 (b) of the North American Free Trade Agreement (NAFTA) : where, for works of art, or for reasons connected with the protection of patents, copyrights or other exclusive rights, or

proprietary information or where there is an absence of competition for technical reasons, the goods or services can be supplied only by a particular supplier and no reasonable alternative or substitute exists;

Article 1016 (d) of the North American Free Trade Agreement (NAFTA) : for additional deliveries by the original supplier that are intended either as replacement parts or continuing services for existing supplies, services or installations, or as the extension of existing supplies, services or installations, where a change of supplier would compel the entity to procure equipment or services not meeting requirements of interchangeability with already existing equipment or services, including software.

ArticleXV (b) of the World Trade Organization/Agreement on Government Procurement (WTO/AGP):when, for works of art or for reasons connected with protection of exclusive rights, such as patents or copyrights, or in the absence of competition for technical reasons, the products or services can be supplied only by a particular supplier and no reasonable alternative or substitute exists;

ArticleXV (d) of the World Trade Organization/Agreement on Government Procurement (WTO/AGP): for additional deliveries by the original supplier which are intended either as parts replacement for existing supplies, or installations, or as the extension of existing supplies, services, or installations where a change of supplier would compel the entity to procure equipment or services not meeting requirements of interchangeability with already existing equipment or services

8. Ownership of Intellectual Property

The Contractor will own the IP.

9. Period of the Proposed Contract

The contract period shall be from date of contract award for one (1) year with the option to renew for three (3) additional periods of one (1) year each.

10. Estimated Value of the Proposed Contract

The total value of any contract emanating from this Advanced Contract Award Notice (ACAN) shall not exceed $222,602.00, including all option years, travel and living expenses and all applicable taxes

11. Closing Date and Time

The Closing Date and Time for accepting Statements of Capabilities is November 12, 2015 at 2 p.m. EDT.

12. Contact Person

All enquiries must be addressed by e-mail to:

Yvonne Murphy

Senior Procurement and Contracting Officer

Email: yvonne.murphy@hc-sc.gc.ca