Project Management in the Review Process DRAFT Qs and As for Sponsors

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Contact: Regulatory Affairs Division

1. What is project management?

Project management is a systematic approach to carrying out a specific body of work within an established timeframe. It includes identification and planning of resources, tools and tasks available and required to complete the work.

2. Why adopt a project management approach to the submission review process?

As an element of the Therapeutic Access Strategy (TAS) initiative on business transformation, a project management approach has been adopted to the review process in the Biologics and Genetic Therapies Directorate (BGTD) in order to strengthen current review management practices. It is expected that increased efficiencies will be achieved through improved communication within the teams, setting of associated achievable milestones, pro-active troubleshooting and problem-solving, co-ordination of the review process and progress monitoring.

3. What will project management mean for the submission process?

The objectives of this initiative are to generate overall improvements in the submission review process by:

• addressing inefficiencies in the existing process;
• preventing unnecessary delays;
• establishing reliable monitoring and evaluation of the submission management processes; and
• improving transparency and predictability through a well documented critical path.

4. How will project management be implemented?

BGTD has taken a phased-in approach to implementing project management to submission review and processing.

Phase One - The initial phase will commence October 2004 and will consist of two arms:

Arm 1 will apply project management to a focused group of submissions in our current workload.

Arm 2 will apply project management to a submission in the Centre for Biologics Evaluation (CBE) and a submission in the Centre for the Evaluation of Radiopharmaceuticals and Biotherapeutics (CERB), from acceptance to decision. A comprehensive project plan for a new submission in each evaluation centre will be implemented and monitored throughout the review process from acceptance to final decision in the Directorate.

Phase Two
Roll out of project management to all submissions under review in BGTD is anticipated once the initial phase has been implemented and modifications to the approach have been introduced based on lessons learned. An implementation date for Phase Two will depend on the progress of Phase One.

5. What are the criteria for choosing submissions to be part of Phase One?

Arm 1 will apply to all New Drug Submissions (NDS) and Supplemental New Drug Submissions (S/NDS) in more than 400 days in backlog¹, as well as priority reviews and NOC-c submissions.

Arm 2 will apply to at least one submission in the Centre for Biologics Evaluation (CBE) and the Centre for the Evaluation of Radiopharmaceuticals and Biotherapeutics (CERB). Preference may be given to submissions that receive advanced consideration for NOC-c or have been granted priority review status. Participation in project management will not affect the position of the submission in the review queue.

6. What are the key objectives within the initial phase of project management implementation?

• Increase team coordination on reviews by improved team communication and setting target dates for completion of each submission;
• ensure that a plan is in place for each submission, which includes strategies that will be undertaken to meet the pre-determined target date; and
• increase pro-active communication with sponsors on progress of their submissions in this project.

7. What can sponsors expect of BGTD for their submissions chosen for Phase One of project management?

Sponsors with submissions that meet the criteria for phase of the project management will be notified in writing that the project management approach is being applied to their submissions. The sponsor may need to be available for consultation with BGTD at predetermined times. A project plan will be developed for each of these submissions and key milestones will be communicated to the sponsors. Sponsors will be informed of the progress of the review and whether BGTD expects deviations from the communicated project plan. Should any major changes arise where milestones are not met, contingency plans will be prepared and these will be communicated to the sponsor.

8. What are the roles and responsibilities of the Project Team Members?

BGTD has taken a team approach to project management. For each submission, a Project Lead will be identified from each evaluation stream (eg. chemistry & manufacturing and clinical) and a Project Coordinator will be identified from the appropriate Regulatory Affairs Division (formerly Submission Management Division). The Project Coordinator is responsible for coordinating the review plan and all communications between the Centres and the sponsors. Specifically, the Project Coordinator is responsible for coordinating the review team, review process, and communications amongst the team, Health Canada and the sponsor. The Project Leads ensure that a review plan is prepared, target dates are met or contingency plans are developed.

Other responsibilities of the Regulatory Affairs Divisions and Evaluation Centres will be maintained.

9. How will submissions be monitored throughout the review?

Monitoring of the projects (submissions) will be the primary responsibility of the project leads and project coordinators. Assessments of the progress will be made throughout the project to ensure that key milestones are met.

10. How will the impact of project management implementation be evaluated?

Monitoring of project management implementation will be ongoing. The impact of the project management approach on review process and targets will be evaluated throughout 2005/2006. An evaluation plan will be developed to assess the extent to which performance targets are being met, and identify what worked or what did not work. The evaluation results will help assure that future implementation rolls out smoothly.

11. Can sponsors decline participation in the initial phase of project management if their submissions are chosen for either Arm?

Project management is an internal tool that is being adopted by BGTD to assist in the managing of submission workload and is not an elective option. While feedback is welcome, no additional expenses are required from sponsors.

12. What will project management ultimately mean for sponsors?

Upon full implementation of project management in the submission review process, sponsors can expect:

• fewer unexpected delays;
• increased access to information regarding their submission;
• increased communication with BGTD; and
• improved transparency of the review process.

13. What other key initiatives will contribute to efforts to improve the submission review process?

The project management approach will draw from other TAS initiatives such as Good Review and Good Guidance Practices, Alternate Dispute Resolution and International Regulatory Cooperation activities undertaken within Health Products and Food Branch.

14. Have staff been adequately trained?

In preparation for this initiative, staff training in project management began in early 2004 and will continue through 2005. BGTD staff attended training seminars on Competency-Based Project Management. Participants in this program benefited by learning the value of project management principles and the skills required for planning and scheduling work. BGTD is striving to create a project-based environment, by having all of its employees learn the basic principles and techniques of project management, as well as how to apply this approach to their day-to-day work. Select staff have also received training in MS Project.

¹ Submissions in the final stages of completion will be exempted from this Phase.