PHARMACEUTICAL INDUSTRY CLINICAL ROTATION

THE PROCTER & GAMBLE COMPANY

HEALTH CARE RESEARCH CENTER

8700 MASON-MONTGOMERY ROAD

P.O. BOX 8006

MASON, OHIO 45040-8006

I. Program Director: Todd J. Banks, B.Sc., R.Ph., P.O. Box 8006, Mason, Ohio 45040-8006; office DV2-2B2, internal mail box #586, phone: (513) 622-0191; Fax: (513) 622-1907; email: banks.tj@pg.com

II. Preceptors and Locations: All preceptors are employed in Health Care functions and possess one or more of the following credentials: D.D.S./D.M.D., D.V.M., M.D. ,Pharm.D., Ph.D., R.Ph. Four of our seven technical centers in the greater Cincinnati area are involved in Health Care research. Student clerkship rotations typically are associated with one technical center but may on occasion involve multiple sites.

III. Goal: To increase the student’s awareness and understanding of the activities, responsibilities, and opportunities for clinically oriented and trained pharmacists in the pharmaceutical industry. The goal of the clerkship program is to help the Pharm.D. candidate develop core competencies in drug information procurement, evaluation, and application with strong emphasis on written and oral communication skills.

IV. General Clerkship Description: The Pharmacy Practice Clerkships are experienced-based integrated problem-solving courses designed to help the student become an active participant in providing contemporary pharmaceutical care services. The P&G Industry Clerkship offers a diverse exposure to many of the professional disciplines available to Pharm.D. graduates within the pharmaceutical industry and is especially designed to provide skill development in the area of drug information procurement, critical literature evaluation, and dissemination of medical information. Rotations, based on availability, may include one or more of the following:

· Clinical Operations (development of : protocols, Investigator brochures)

· Rx to OTC switch strategies

· Licensing & Acquisitions of pharmaceuticals and medical devices

· Managed Care & Pharmacoeconomics

· Professional & Scientific Affairs

· Pharmacovigilence and Safety Surveillance

· Medical Communications

· Regulatory Affairs & Governmental Relations

· Risk Assessments & Safety Assessments

· Epidemiology

· Disease Etiology & Management

· Pathology & Toxicology

· Product Labeling Optimization (readability and comprehension)

· Health Care Marketing & Advertising

Clerkship rotations do not involve direct patient care/contact or pharmaceutical dispensing. Rotations are designed to provided students an integrated approach to a multifunctional team of health care professionals responsible for developing and maintaining pharmaceutical products in the marketplace. Clerkship opportunities are available in both our prescription and nonprescription divisions. Rotations are typically designed for one calendar month and are offered through an Affiliation Agreement between participating Universities and The Procter & Gamble Company. With approval, a tandem (8 – 10 week) rotation can be accommodated.

V. Clerkship Objectives:

· Describe in detail, the services provided by pharmacists and other health professionals as it relates to the Department hosting the Pharm.D. clerkship, especially as it pertains to the provision and integration of medical and pharmaceutical information.

· Gain exposure to various departments with the pharmaceutical industry including, but not limited to, Pharmacotherapy & Pharmacodynamic Education, Medical Information, Pharmaceutical research and development, Disease management, Clinical Research, Pharmacoeconomics, Managed Care, Pharmaceutical Sales/Marketing/Advertising and upstream technologies.

· Discuss in detail the current therapeutic advantages and disadvantages for the specific products of interest and how each is viewed from a medical and marketing perspective.

· Become familiar with common company and FDA policies for postmarketing surveillance and pharmacovigilence, including the distinction between medical communications and scientific exchange.

· Enhance literature searching and retrieval skills.

· To assist the Pharm.D. student in expanding the breadth and depth of their practice capabilities by providing post-graduate experiences and interactions relevant to the role of Pharm.D.s within industry.

VI. Responsibilities:

· To be determined by the preceptor and assigned project. Responsibilities, performance measures/goals and learning objectives will be provided to each student upon arrival at the clerkship site. All rotations are “teaching assignments” and students are expected to demonstrate enthusiasm and a willingness to learn.

· Work on various projects initiated by the preceptor or student, under the supervision of the preceptor.

· Complete all reading materials assigned by the preceptor(s) and be prepared to participate in discussions regarding the readings.

· Attend all relevant product and/or departmental meetings (as appropriate).

· Prepare and present a seminar reviewing clerkship learnings, including summarizing progress made on the project and proposal of next steps. The audience should include directors, managers, and department colleagues.

VII. Miscellaneous:

· Must be able to provide means of transportation and own housing.

· Must be willing to sign a confidentiality agreement.

· Student must obtain a temporary I.D. badge for the clerkship (provided on site).

· Students will be provided with a cubicle, computer, printer, phone, email/internet access, and the necessary office supplies. Use of office equipment (i.e., copy machine, fax machine, etc.) is allowed when appropriate.

· Must be a highly motivated student with excellent written and oral communication skills.

· Must provide a copy of updated curriculum vitae to the preceptor prior to start of rotation.

· Business casual attire is appropriate.

VIII. Scheduling/Attendance:

· Call preceptor at least two weeks prior to start of rotation for clerkship details and logistics. Students electing an eight-week rotation must choose two consecutive months and obtain permission from the university.

· Usual hours are 8:00am to 4:30pm although flexibility in start and stop times can be accommodated with concurrence from the preceptor.

· While the necessity for some students to work during school is recognized, students should make every effort to minimize the number of hours worked to gain the maximum benefit from the clerkship experience. Students should not schedule work hours that conflict with their clerkship commitments.

· In the event the student cannot make it to work, he/she should call (513) 622-1000 and ask to speak to the preceptor or the preceptor’s assistant.

IX. Student Assessment:

Students will be evaluated at the midpoint and at the conclusion of their rotation based upon:

1. Attendance and Professionalism

2. Completion of assigned project(s)

3. Assessments of performance measures outlined in project orientation materials

4. Communication skills

Grades will be based on successful completion of course objectives and assigned project(s).

X. Grading/Course Evaluation

· The student will be evaluated twice during the clerkship. An interim evaluation will be conducted at the midpoint of the clerkship, and a final evaluation will be conducted on the last day of the clerkship.

· Each student will provide a completed course evaluation and preceptor/site evaluation at the end of the rotation.

· The student’s grade will be determined based on the following scale:

· O = Outstanding, consistently exceeds expectations

· S+ = Consistently meets & sometimes exceeds expectations

· S = Satisfactory, consistently meets expectations

· S- = Sometimes meets expectations

· NA = Not Applicable

· U = Unsatisfactory