the pharmaceutical education & research institute,...

2014 CORPORATE EDUCATION PROGRAMS

The Pharmaceutical Education & Research Institute, Inc.

The Pharmaceutical Education & Research Institute, Inc. CORPORATE EDUCATION CATALOG PAGE 2

PERI’s MISSION:

- To optimize the effectiveness of those involved in the development, review and approval processes for health care products through our education and training programs; - To foster professional growth through training and the sharing of information and knowledge in

the research, development, manufacturing, marketing and post-marketing surveillance of health care products; and - To enhance the professional effectiveness of our constituencies by providing training and

accredited continuing education for physicians, nurses, pharmaceutical professionals and others, that meets or exceeds established standards.

Adopted by the PERI Board of Directors in November 2000.

PERI’s BOARD OF DIRECTORS:

William J. DeLorbe, PhD Chairman Vice President Human Resources Pharamcopeia Jonca Bull Vice President US Drug Regulatory Policy Novartis C. Robert Eaton President and CEO Your Bio Team David I. Goldsmith, MD President & Senior Consultant Goldsmith Pharmacovigilance & Systems

Judith K. Jones, MD, PhD President PERI, Inc. Anthony J. Piraino, MD, PhD, FACP Senior Director Clinical Research AstraZeneca Pharmaceuticals, L.P. Claudio P. Spiguel, PhD Adjunct Professor Alfred Lemer College of Business and Economics University of Delaware

Gillian R. Woollett, MA, D.Phil Vice President, FDA Regulatory Policy Avalere Health

9302 Lee Highway • Suite 700 • Fairfax, VA 22031 1-571-490-8409 www.peri.org PAGE 3

CORPORATE EDUCATION PROGRAMS

PERI’s Corporate Education Programs are delivered directly to your company at your facility, and can be tailored to your company’s specific educational needs and objectives. For more than 10 years, PERI has been providing the highest level of on-site education to the pharmaceutical, biotech and medical device industries.

PERI’s Corporate Education clients include over 350 pharmaceutical, biotechnology and government organizations. Check our website at

www.peri.org for updates on all of our course offerings.

PERI Corporate Education Programs are…

Cost Effective: You can save time and money by having PERI train a group of 15 or more team members at the location of your choosing. Reduce travel expenses, time away from work and more with training on-site or at a nearby location.

Customized Programs Developed By Expert Faculty:

Courses are designed to address the specific needs of your company by expert PERI faculty, many of which have years of industry and educational experience.

Additional Features & Benefits: - PERI’s open courses are available to

corporate education clients for customized group education

- Discounts are available for multiple courses

- Programs can be offered to virtual audiences via webinar/webcast

- Programs can offer continuing education credits for Physicians, Nurses, Pharmacists and others


PERI’s Customized Webinar/Webcast and Blended Education Programs

In addition to on-site training with PERI staff and faculty, consider adding webinars and webcasts to your curriculum! Customized blended-education programs are available to supplement live learning and enhance the training experience. Combining webinars/webcasts with live learning also helps reduce program expenses! Topics Include: - Overview of Biopharmaceutical Development - Cancer 101 - Toxicology for Non-Toxicologists - Good Clinical Practices - Postmarketing Safety Reporting - Data Monitoring Committee - Imaging Approaches to Oncology Drug Development - PIP (Pediatric Investigation Plan) - Risk Management: EMA Perspective - Biosimilars: Development Considerations and

Current Regulatory Environment - Drug Labeling - Statistics 101 - Pharmacoeconomics - Global Pharmacovigilance - Cancer: Pathophysiologies - Drug and Biologics Manufacturing - Overview of Prescription Drug Labeling Regulations - And Many More!

Student Testimonials Here’s what PERI participants are saying:

On Cancer 101: “I can now begin to work in oncology with a baseline understanding of the therapeutic area.”

On Clinical Development: “Invaluable course, especially for first time researchers.”

On Clinical Trial Management: “This course helps me to better understand the development and correct documentation for all the agencies that monitor clinical trials.”

On Drug Development: “Love the workshops! Excellent activities and follow-up discussions. I learned that it is not easy to manage a portfolio because of all the elements you must consider.”

On Global Regulatory Affairs: “I can now interact more effectively with regulatory affairs experts in different regions.”

On Good Clinical Practices: “A great refresher for prior GCP courses; gives a broad picture about clinical trials.”

On Project Management: “Honestly, the best and most useful of all the courses I have taken with PERI!! I found some things to try on my research-phase project, i.e., how to approach timelines and how to address the pushback on the ‘you can’t predict science’ mindset.”

On Regulation of Marketing: “I am better able to medically review promotional pieces with an understanding of FDA and DDMAC’s perspectives.”


Fundamental Training Programs

Decisions in Drug Development: Portfolio Management Workshop is a highly interactive, hands-on learning experience! This 4-hour workshop provides an overview of the processes and challenges common to all new development products, basic drug development steps and ideal characteristics of a development candidate. Interactive workshops will then follow the development of a drug from discovery to product label development.

Drug Development: Overview of Biopharmaceutical R&D provides an overview of the processes and challenges common to all product development projects. Interactive workshops will follow the development of a drug from discovery to product label development.

Drug Development Decisions: The NDA Simulation provides a better understanding of the drug development and regulatory processes by simulating a "company project team" working together to get their "drug" approved with the required label and within projected timeline and budget. The initial portion of the course provides didactic presentations, which provide the groundwork for the IND and NDA Game simulations.

Biologics Product Development provides an overview of the processes and problems common in Biologics development. Participants will understand development decision points from initial identification to post-approval monitoring.

Medical Devices: Demystifying Regulation and Guidance provides an overview of safety considerations of medical devices. This course identifies critical definitions, classifications and device categories.

Pharmacology Concepts provides an intensive overview of pharmacology, including the principles of pharmacodynamics and pharmacokinetics. A general introduction to selected therapeutic areas is also included, and can be tailored to your company’s area of specialty. Specific courses are also available on Pharmacokinetic Concepts and Applying Pharmacokinetics and Pharmacodynamics.

Oncology Cancer: Introduction to Oncologic Product Development is designed to cover oncologic clinical trial design from Phase I through Phase III. In addition, the course provides an overview of human cancer pathophysiology and current therapeutic issues relevant to the client’s specific development areas. Also available is Cancer 101: A Basic Overview of Oncology Drug Development, which provides a foundation for new oncology researchers.

Intermediate and Advanced Concepts in Oncologic Product Development is designed to cover oncologic clinical trial design considerations and regulatory issues. Topics include: Clinical trial management operational issues, chemoprevention, angiogenesis inhibitors, new imaging approaches, and cancer pathophysiologies.

CORPORATE EDUCATION COURSES


Oncology Development: Overview for Market Planning provides an introduction to the cancer disease process and an overview of treatment method categories for the purposes of market planning. Also discussed is an overview of the design of oncology clinical trials and the approval process of oncology drugs. Specific cancer therapeutic areas can be tailored to client’s needs.

Quality Assurance and Compliance Good Clinical Practices and Advanced GCP provides a background in Good Clinical Practices (GCP) as applied to clinical trials conducted worldwide. The Advanced course focuses on GCP auditing techniques and strategies, providing in-depth application-oriented experiences.

Clinical Monitoring: Essential Concepts presents an overview of clinical monitoring in the context of the overall drug development process, FDA regulations and International Conference on Harmonization (ICH) guidelines for Good Clinical Practices.

Good Laboratory Practices addresses regulatory compliance principles relative to the FDA’s current Good Laboratory Practices (GLP) regulations. Topics include: development of GLPs, roles and responsibilities of key staff members, SOPs, laboratory facilities, and computer validation issues.

Project Management and Leadership Development Project Management and Leadership Strategies for Pharmaceutical Scientists focuses on improving the leadership skills of project leaders and mid-level line managers who work in an environment that requires collaboration in order to be successful. The program uses an analytical model of leadership that is readily accepted by technically oriented people.

Clinical Research & Development Asthma and COPD: Clinical Drug Development provides a comprehensive overview of asthma and COPD as a basis for developing new drugs to more effectively treat these diseases. Pulmonary physiology, pulmonary physiology testing, current treatment approaches, and a review of regulatory policies in this area will be used to discuss recent approaches to developing new drugs for asthma and COPD.

Cardiovascular Product Development provides an overview of advances in cardiovascular drug development. Topics include anatomy and physiology associated with hypertension, coronary disease, heart attack, and heart failure; coronary and peripheral artery disease, thrombosis, and anticoagulation, cardiac arrhythmia and clinical trial methodology are discussed. Topics on cardiac-related medical devices can also be included.

Clinical Trial Management and Operations addresses trial management issues and skills needed to effectively conduct trials in the fast-paced drug development industry. The course presents a variety of topics on trial planning, operational aspects, organizational tips, resource planning ideas, financial implications, timeline concerns, regulatory implications, communication, and team building.


Clinical Trial Management and GCP Essentials provides a foundation of GCP concepts, followed by a focus on auditing techniques and strategies, clinical trial management issues and skills needed effectively conduct trials in the fast-paced drug development industry.

Clinical Investigator Training instructs practicing physicians on the basics of planning and implementing clinical research trials. Topics can be tailored to provide information on specific disease states, protocols and other company-specific details.

Regulatory Affairs Global Regulatory Affairs provides participants with an overview of the laws, guidelines and regulations governing the development and registration of prescription pharmaceuticals outside of the United States. Regions specific to our client’s needs are covered.

Global Pharmacovigilance focuses on introductory concepts of global regulatory requirements in drug safety. Topics include MedDRA, basic epidemiological issues, signal detection and risk management.

Regulation of Marketing and Promotion of Prescription Drugs addresses current laws, guidelines and regulations governing the marketing and promotion of prescription drugs and biologic agents. An overview course on Prescription Drug Labeling Regulations is also offered.

Regulatory Inspections: Preparation and Practice describes the necessary steps in preparing for a Regulatory Site Inspection. Key topics include current inspection issues, differences in inspections from global agencies, handling inspections and preparing for inspections. A mock “Site Audit” can be conducted as a practical exercise, followed by a debriefing of the inspection findings. Also available to audiences of varying experiences: Preparing for an Advisory Committee Meeting.

Additional Courses Available … Or Customize Your Own! - Oncology Development: Regulatory Considerations - Filing IND, NDA, BLA - Immunology - Clinical Data Management - Vaccine Development - Pharmacology: Advanced Concepts - Product Launch - Managing Outsourcing to CROs - Managing Investigator Initiated Research - Effective Negotiations in BioPharma - Protocol Writing - SOP Development - Conducting Phase I Trials - Preparing for an Advisory Committee Meeting - US Regulatory Overview - Diabetes: Epidemiology and Pathologies - Metabolic Syndrome - CMC in the CTD


CONTINUING EDUCATION CREDITS

PERI is pleased to make continuing education credit available to you for participation in Open Courses, Corporate Education and Distance Education Programs. Applying for credit is simple! To receive credit, you must participate in the entire program, and submit a Continuing Education Application. To receive credit for a Distance Education (DE) course, you must complete all course requirements (i.e., quizzes and/or case studies), complete the program evaluation, and submit an email request for DE credit. Your Continuing Education Certificate will be mailed upon course completion.

PERI, Inc. is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.

PERI, Inc. is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Note: Please check our web site for the most current information on our continuing education offerings.

PERI CERTIFICATE PROGRAMS Document your professional development and education with PERI’s Certificate Programs. These education tracks are specifically and expertly designed to enhance the knowledge and skills needed for your particular job function. Select the Certificate Program that best matches your professional development needs: Basic Research, Clinical Sciences, Project Management, Safety Labeling or Quality Assurance/ Compliance. Choose the PERI courses you wish to attend from the core and elective courses listed within each program. You must individually register for each program you wish to attend independently of the certificate program application. When you have completed the online application, as well as the number of required courses, notify PERI’s registration office when you have completed the curriculum. Upon confirmation of completion, your certificate will be mailed to you! There is no additional cost (beyond the course registration fees) for you to enroll in any PERI Certificate Program. For in-depth information and program requirements for PERI’s certificate programs, please visit our website at http://peri.org/peri-certificate-programs/.

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