Industrial Pharmacy Studentship Program

Introduction

The Rx&D Industrial Pharmacy Studentship Program was first established in 1978. The program is an initiative of and is administered by Canada's Research-Based Pharmaceutical Companies (Rx&D), in cooperation with the Association of Deans of Pharmacy of Canada (ADPC).

Background and Objectives

The Industrial Pharmacy Studentship Program provides pharmacy students an opportunity to experience first-hand work in an industry setting. As an employee of a research-based pharmaceutical company, students also become aware of the important role Rx&D member companies play in Canada's health care system. This exposure to industrial pharmacy permits students the opportunity to follow the drug development process from pre-clinical research to marketing. As a result, pharmacy students are given a unique opportunity to learn about specific components of the drug development process. In addition students:

• Gain insight into applied research, drug product development and formulation;
• Work with pharmaceutical scientists and technicians in the laboratory — the beginning of “bench to bedside” innovation;
• Interact with industry specialists and executives;
• Learn about the business aspects of pharmaceutical development, manufacturing and marketing;
• Expand and apply the scientific knowledge and skills acquired through course work at the university; and
• Learn about career opportunities for pharmacists in the pharmaceutical industry.

Description

Supervised by a Preceptor, studentship programs are generally comprised of project-oriented assignments in several company departments. The aim is to give students broad exposure to company operations. However students may be assigned to a longer term project in a single department. Type and length of assignment may vary from company to company and adjustments may be necessary. Generally, assignments are carried out in the following areas:

Regulatory Affairs

The Federal Government regulates all therapeutic products, which includes pharmaceuticals, biologicals, radiopharmaceuticals and medical devices. The Regulatory Affairs department is responsible for ensuring that the company complies with the Federal Government's regulatory requirements. This includes submission and approval of applications to market new drugs, new uses (indications) for marketed drugs and new formulations. Regulatory Affairs is also responsible for submissions to enable the conduct of clinical research studies in Canada.
Scientific review and assessment of available data, preparation of summaries and compilation of data, and ongoing interaction with HPB are all part of the process. In some companies, the Regulatory Affairs department may also be involved in the preparation of submissions to provincial governments and third party payers. The Regulatory Affairs department interacts with a number of other company functions, including marketing, clinical research, medical information, quality control, quality assurance, manufacturing, as well as international regulatory groups.

Research and Development

Clinical Research

Pharmacists, with training in clinical protocol (usually obtained with a Pharm D. degree) can provide a useful link between the physician executing a study and the clinical research group evaluating a new medicine.

Pharmaceutical Development

Many pharmacists engaged in research in the industry are involved in the pharmaceutical development area. Formulation of newer and more specific medicines is an extremely vital function, as the effectiveness and safety of a medicine may be substantially affected not only by the quantity of the active ingredient, but also by the inactive ingredient used, and the method by which it is formulated, manufactured and packaged.

The formulation pharmacist may perform physical tests for stability; may send samples to the analytical laboratory for chemical data on stability; may manufacture product on a small scale, and may work with a pharmacologist, biochemist or clinician in determining the absorption and elimination patterns of a drug product.

Quality Control/Assurance

Quality Control is one of the most important phases of the manufacturing process. It is an organized system of checks, tests and safeguards to assure that a finished medicinal product meets certain standards of potency, purity, uniformity, stability and safety.
Quality Control starts with the arrival of the diverse raw materials at the plant and must be built in to all stages of the manufacturing process. Quality Control responsibility, as well, ultimately extends through to the multiple phases of product distribution.

Production

Raw material (active drug substances and exipients) are purchased from approved vendors and tested by the Quality Control Department. Upon approval, they are compounded in the desired pharmaceutical dosage form according to precise manufacturing directions. After successful testing, the bulk pharmaceutical dosage form is packaged in the desired approved packaging system. All operations are performed under the supervision of qualified personnel amongst which can be found pharmacists.

Marketing

Marketing in the pharmaceutical industry involves developing marketing plans and product promotions often working closely with advertising agencies. Marketing personnel also work closely with the medical department to ensure the accuracy of medical information and collaborate with industrial engineers in package and label design. Marketing practices are reviewed with PAAB to ensure adherence to relevant Canadian pharmaceutical marketing guidelines.

Market research is a component of industry marketing and sales with studies and analyses being done in areas such as customer needs, sales forecasting, efficacy of product promotion and the development of new market strategies.

The sales representatives are among the most important sources of information for the medical and pharmaceutical professions. Representatives receive initial and continuous training on medical aspects of pharmaceutical therapy and function not only as the conveyors of up-to-date information to the community and hospital pharmacist and physicians but also as the channel for feed back to the company information about practical experience with the company's products.

Medical Information

The Medical Information Department responds to inquiries from both doctors, pharmacists and patients. Through literature searching and evaluation of literature, they provide answers to the inquiries. In many cases, this department also takes care of drug safety issues by collecting data related to adverse drug reactions and ensuring it is properly recorded and reported.

Government Relations/Corporate Affairs

This area in the pharmaceutical industry is the major link of the company to government, medical and pharmacy professionals, the academic and scientific community and consumers.
In many pharmaceutical companies government relations/corporate affairs is involved in:

• Preparation of submissions to provincial government and private health care providers to obtain reimbursement from provincial formularies and private drug plans.
  
• Liaison with medical and pharmacy professionals including coordinating continuing pharmacy and medical education.
  
• Representation of the company and its interest to various Federal and Provincial Departments such as Health and Industry.

Pharmacoeconomics

Pharmacoeconomics concerns the application of the methods of economic evaluation of health care programs to interventions involving pharmaceutical products. The purpose of the methods, and the studies, is to help inform programmatic decision making regarding the appropriateness and availability of health care procedure including drugs. Results of such programmatic decision making (e.g. formally listings, clinical guidelines, appropriate prescribing practices) will often impact on decision making regarding treatments from individual patients; but it is important to note that the methods of economic evaluation are generally not directly targeted at bedside decision making.

Eligibility

Students in good standing, who are completing the 3rd year of a B.Sc. Pharm. program (or 4th year of a 5-year program) at a Canadian faculty/school of pharmacy.

How to apply

Application forms and guidelines are distributed through the Senior Representative of the Canadian Association of Pharmacy Students and Interns (CAPSI) at each faculty and are available on the Rx&D website. A limited number of studentships of approximately 4 months duration are available each year.