VI. PROGRAM

1. The intention of the general residency is to educate the resident about different areas of industrial pharmacy and to provide an opportunity to gain industrial experience. The specialty residency enables the resident to focus their activities on one or two particular areas of interest.
   
   
2. The general residency is composed of core rotations through many of the company's departments, thereby ensuring a broad exposure to all facets of industrial pharmacy. In addition, the resident will have the opportunity to carry out a major project which will develop the resident's research and investigative skills and the preparation and writing of reports. Finally, the resident will be able to develop their special areas of interest in conjunction with those of the Company in the elective portion of the program.
   
   
3. The program must have an encompassing base which will give the resident the requisite exposure to ensure that the year of special study has a definite and positive value. This value comes in part from the educational background and insight of the pharmacy resident and the overview which the resident receives in the areas of research, manufacturing, testing, regulatory affairs, marketing, sale of pharmaceuticals, medical information, post marketing surveillance, managed care and pharmacoeconomics. A resident must understand how all these company activities interrelate and the impact they have on the various health professions. Furthermore, the program consists of practical experience and must be knowledge-based and problem-solving in dimension. The resident should finish the program with an appreciation of the relative merits of empirical and theoretical approaches to solving problems. Finally, the resident should complete the program with a tangible gain in skills and knowledge demonstrated by an ability to perform identifiable tasks.
   

In order to provide flexibility while ensuring an encompassing base for the program, a six month core consisting of at least six core rotations and a major project, plus six months of elective activities are required to be provided by the participating companies to form the twelve month program.

1. OUTLINE OF PROGRAM

   Time (months)	Activity
   	Core Rotations
   0.5	Product formulation/reformulation -- development; accelerated stability.
   0.5	Production -- purchasing raw materials; inventory control; scheduling; packaging, actual hands-on production.
   0.5	Quality control -- raw materials; finished products; stability testing; self-inspection; recall program.
   0.5	Product marketing -- strategy; programs.
   0.5	Clinical research
   0.5	Regulatory affairs
   0.5	Drug information
   0.5	Sales training
   0.5	Managed care
   0.5	Pharmacoeconomics
   3.0 Major project
   6.0	Total core program
   6.0	Elective Activities
   12.0	Total program

   Some definitions of the above terms are provided in Appendix III.

   
   
2. The Company Supervisor will provide the resident with a list of the Goals and Objectives for each core rotation and each elective activity. The department head or delegate in each of the above rotations will be requested by the Company Supervisor to provide a brief report on the involvement of the Resident in the department.
   
   
3. The Resident will submit reports in each rotation to the Company Supervisor and a final summary report along with the project report to the Core Committee. The Resident will be invited to attend the meetings of the Core Committee to evaluate and discuss his/her experience, and should be encouraged to make a presentation on his/her project. The department head or delegate of each rotation are encouraged to complete a form in order to provide feedback to the resident.
   
   
4. The purpose of the elective activities is designed to meet the special interests of the resident and can involve additional time in any one of the core rotations, or other areas of expertise offered by the Company. The companies which do not have Product Formulation, Production and Quality Control (in house), are encouraged to liaise with other participating companies in order that the resident have some exposure to these activities. Other items to be listed under elective activities may include Professional Affairs and Pharmaceutical Association work.



5. List of general residencies:
   
   Hoffmann-LaRoche Ltd.
   ratiopharm
   
   
6. A check list of requirements for the residents in order that the program may be successfully completed on time is:
   
   General Program
   
   1. At least six core rotations each of at least two weeks duration (see p3)
   2. Major project
   3. Elective activities
   4. Two meetings of the Core Committee

The Specialty Residency is 12 months in duration and provides a slightly different stipend support. In contrast, however, this program empowers the specialty resident to focus activities in one or two particular departments. This focus provides the unique opportunity to develop specialty skills in a chosen area of interest. These skills are highly marketable in the pharmaceutical industry.

Possible areas of opportunity the candidate may choose are provided below along with the associated company.

The specialty resident participates in the daily activities of the area chosen in order to gain an understanding of the operations of that department as well as to achieve the necessary competencies in that position. Projects will be chosen by the resident offered by the supervisor, including a major project. Opportunities to attend seminars and conferences relating to both pharmacy and the area of specialty are pursued.

A check list of requirements for the residents in order that the program may be successfully completed on time is:

1. Full daily active educational participation in the selected area of the residency e.g. Health Economics, Medical Information.
2. Major Project
3. Two meetings of the Core Committee

1. During the first week of the resident's program, the resident should be introduced by the supervisor to the people who are responsible for the program in each of the core areas. It is highly recommended that small projects be planned for the resident in each of the core areas. This will enable the resident to achieve a greater depth of understanding, appreciation and interest in the various areas. In addition, it will assure that the resident will learn something more worthwhile in each of the core rotations. It needs to be stressed that this must be a learning experience for the resident. The resident should not be filling a staff position or used to do relief work.
   
   
2. The resident's registration fee ($50) for the University will be paid by the Company or a combination of the Company and the resident. This allows the resident to use the University of Toronto Library.
   
   
3. The Company should endeavor to provide the resident with a permanent work station in order to give the resident a space in which to prepare reports and to facilitate communication.
   
   
4. The Company Supervisor should increase the awareness of the resident within the Company by such means as the Company newsletter, the bulletin board, or other suitable means. It would also be beneficial if the current resident could meet with the new resident so that a better understanding of the program can be provided.
   
   
5. The Core Committee oversees the residency at a particular company, and is composed of:
   
   

   Company Supervisor - at the participating company
   Faculty member - Liaison

   It is essential that The Core Committee meet at least twice during the residency in order to help in the direction of the program and the project. The first meeting should take place within the first month of the resident's program and other meetings should be tentatively set at the first meeting. It is the responsibility of the Company Supervisor to ensure that the first meeting will be held early in the program so that the resident has an early contact with the Liaison.

6. The primary role of the Faculty Liaison is to serve as an advocate for the resident, and to assure that the goals of the residency are being met. In this role, the Faculty Liaison must meet early in the residency with the resident and Company Supervisor to establish a program for the resident. This program should be consistent with the purpose and structure of the Residency Program.
   
   
7. The Faculty Liaison should be involved in the design and evaluation of the major project. Should the project be in an area different from the expertise of the Faculty Liaison, it is the responsibility of the Faculty Liaison to identify a member of the Faculty to become involved with the project design and evaluation.
   
   
8. At one meeting, the resident shall outline the major project and describe the intended research strategy. At this meeting, the Core Committee shall formally accept or reject the proposal. In addition, the progress of the resident is to be assessed. At the final meeting, the resident shall review for the major project the research describing the methodology, findings, solution/recommendations, and suggestions for possible future research related to the project findings. Although the written report may not yet be completed at this stage, the Core Committee shall formally accept or reject the major project as partial fulfillment of the requirements for the residency program, contingent upon receipt of the an acceptable final project report. If the final meeting is positive and all other requirements have been met, the recommendation for awarding the certificate can be made.
   
   
9. Overall direction and guidance for the program will be provided by the Program Committee, composed of the following persons:
   
   

   • Dean of the Leslie Dan Faculty of Pharmacy, University of Toronto or his designate
   
   
   • Industrial Pharmacy Residency Coordinator
   • Faculty Liaison Members
   
   
   • Representatives from the Companies - Full time
   Company Supervisor of each program
   
   • OPRA Representative

   
   with whom the ultimate responsibility for all aspects of the program rests. The Program Committee will meet annually in April to guide the Residency Program.
   
   
10. Should issues or problems arise during the residency, the resident should in the first instance attempt to resolve these with the Company Supervisor. If this fails, however, the resident should then seek the advice and direction of the Faculty Liaison to resolve the problem. Should the problem not be resolved in this manner, the resident should then contact the Dean of the Faculty of Pharmacy and the Industrial Pharmacy Residency Program Coordinator.
    

1. Philosophy:

   
   To conform with the Industrial Pharmacy Residency Program Committee Requirements, a major project must be undertaken and successfully completed as partial fulfillment of the residency program. This requirement is to assist the resident in gaining practical problem solving experience. It is anticipated that the resident will obtain a rudimentary understanding of conventional research in which an identified problem or question generates a systematic investigation to arrive at a solution. The project need not be an original idea or issue. However, it should not solely be a literature search. Rather, it must follow the general steps of a) problem identification; b) determining the information currently available; c) setting out alternative methods to solve the problem; d) selecting an experimental method; e) collecting the data; f) summarizing and critically analyzing the findings; g) stating the solution and/or developing recommendations; and h) suggesting further research work.
   
   

2. Expectations:
   
   
   1. Of the Pharmaceutical Company

      While the project may represent a collaborative venture between various professionals, the company must identify a supervisor who shall take full responsibility for the resident's work.

      Within two months from the starting date of a resident's program, the supervisor shall provide that resident with a reasonable list of potential projects, (normally six or more) from which a selection shall be made not later than January. Alternatively, the problem may be identified and selected by the resident with the approval of the Core Committee.

   2. Of the Resident

      i) The nature of the project
      
      Although many widely differing projects could meet the requirements, several principles shall be applied. First, the project shall be acceptable to the Core Committee. Second, while it may serve the needs of the company, the project shall be worthwhile to the degree that it permits the student to gain practical experience in research. Finally, it is important that the research is feasible and can realistically be completed, particularly in the time frame allotted to the project.
      
      ii) Selecting a project
      
      The Company Supervisor, as previously stated, shall furnish the resident with a list of projects from which the resident can make a choice. The resident may also have independent views on a particular projects. The overriding principle should be that the resident and Company Supervisor agree on a worthwhile project that would permit the research to be carried forward. It is preferable that the results of the major project be published if possible.
      
      iii) The time allotted for the project
      
      In order for the resident to learn about research methodology, three(3) months shall ordinarily be devoted to the project. In the interests of progress, it may be advisable to provide this time in smaller segments rather than as a single block. This might facilitate, for example, the literature review and writing of a protocol.
      
      iv) Reporting on the project
      
      The project shall be presented to the Core Committee as stated previously. A final written report shall also be compiled, organized like a publication, containing for example:
      
      - a title page
      - introduction
      - methodology
      - results
      - discussion including recommendations and relationship to literature reports
      - suggestions for further research
      - conclusion
      - references

      In addition, the resident may decide to include the following
      
      - acknowledgments
      - a one-page abstract (up to 250 words)
      - suggestions for further research
      - tables
      - legends for figures
      - figures
      - appendices, where needed.
      

Bioavailability:

measurements of the rate and extent of drug absorption.

Clinical Research:

the design and monitoring of scientifically valid and ethical studies in humans for investigational drugs, new drugs and new indications for marketed drugs.

Medical/Drug Information:

responds to all medical inquiries from sales representatives, health-care professionals, consumers and departments within the company. Reviews medical literature. Ensures compliance of all medical marketing materials

Post Marketing Surveillance:

monitoring of drug use, adverse reactions and drug effectiveness.

Regulatory Affairs:

gathering, interpreting, summarizing and formatting information to submit to the government for approval for the sale of a drug. Ensuring that all departments of the company operate according to the Food and Drugs Act and regulatory guidelines.

Statistical Analysis:

statistical analysis of data from clinical research and other studies

the processes involved in the creation of dosage forms and their development for commercial use.

Market Access:

Seeking reimbursement through public/private payor.

Market Research:

collecting information on prescribing habits and prescriptions to assist in designing better marketing strategies.

Product Management:

strategic business responsibilities for product(s) from manufacturing through to pricing and advertising with the ultimate goal of making a profit.

Promotion and Advertising:

a product is promoted and advertised to the health science community (e.g. through sales representatives and professional journal advertising).

Consumer Sales:

promoting non-prescription products through displays and other incentives.

Pharmaceutical Sales:

sales representatives call on doctors and pharmacists to familiarize and/or introduce them to the company's products.

Sales Training:

the program(s) necessary to prepare a sales representative to call on doctors and pharmacists in various specialties for the promotion of the company's products and services.

Manufacturing:

the combination and manipulation of raw materials in large quantities to produce the final dosage form.

Packaging:

the assembly of the drug into its container and labeling for shipment.

Quality Assurance:

monitoring to ensure that standard operating procedures are being carried out according to internal procedures and government regulations.

Quality Control:

testing, from the receipt of raw materials to the shipping of the final product, to ensure that standard specifications are met.

the administration of health care resources for the efficient and effective treatment of disease and the promotion of health to enhance the quality of life.

the description and analysis of the costs (i.e. resources consumed) and consequences of pharmaceutical products and services.

Dear Prospective Resident,

Since your application will be your communication with the companies of interest to you, it is essential that it be completed in an intelligent, knowledgeable, neat and clear manner. This application is usually responsible for forming a first impression with the company's supervisor and consequently, is important in the selection of candidates for the residency. The residency often assists the residents in the selection of their future careers.

You should find out about the companies of your choice as suggested in Section III (APPLICATION PROCEDURE), (1) and Section XI (ADDITIONAL INFORMATION), (1). The names of supervisors and areas of activity of participating companies are provided in Appendix I. In addition, annual reports or similar information are provided in the libraries of most Schools or Faculties of Pharmacy. You should have a considerable knowledge about the company so that you may make a suitable selection and are able to answer questions about the company during the interview.

1. The Program Committee of the Industrial Pharmacy Residency Program consisting of the Leslie Dan Faculty of Pharmacy in cooperation with the Faculty of Pharmacy, University of Montreal and the Participating Companies (Eli Lilly Canada Inc., ESI Canada, GlaxoSmithKline, Hoffmann-LaRoche Ltd., Merck Frosst Canada Ltd., Patheon, ratiopharm) has sponsored an Award consisting of a plaque and $1000.00 to acknowledge one resident who has completed a major project of high quality and who has demonstrated leadership qualities and undertaken new initiatives during his or her residency. Residents applying for the award shall provide three copies of their major project and documented evidence indicating leadership qualities and new initiatives during their residency, to the Coordinator, Industrial Pharmacy Residence Program of the Leslie Dan Faculty of Pharmacy by November 1st immediately following the completion of their Residency. Only applicants who have completed all the requirements of the program within one year are eligible to apply for the award.