SUMMER INSTITUTE OF THE GEORGE WASHINGTON UNIVERSITY &

THE EUROPEAN CENTER OF PHARMACEUTICAL MEDICINE, UNIVERSITY OF BASEL

ISSUES AND TRENDS IN REGULATORY SCIENCE

BACKGROUND George Washington University School of Medicine and Health Sciences in cooperation with the European Center of Pharmaceutical Medicine (ECPM) at the University of Basel, Switzerland is organizing an international, multi-disciplinary summer institute, in Washington, DC.

COURSE DESCRIPTION The program will explore how innovative drugs and devices are developed and regulated. Students will have the opportunity to study in Washington, DC; expand their international contacts by solving case studies with regulatory and quality experts from around the world; and visit regulatory agencies such as the Food and Drug Administration (FDA) and the National Institutes of Health (NIH). They will also meet with the government decision makers who control access to the market; listen to policy experts and thought leaders explain the ramifications of proposed regulatory initiatives; and attend sessions taught by the faculty who teach FDA investigators and reviewers.

COURSE OBJECTIVES By the end of the course, students will be able to: • Describe the current regulatory science framework and its role in the decision-making about the risks and benefits of medical products. • Describe innovative research tools and approaches in the field of regulatory science. • Analyze the current healthcare climate and predict its influence on future health care initiatives. • Identify regulatory strategies for product submissions and quality systems. • Recognize new principles and methodological concepts of epidemiology and health economics and classify their impact on public health.

DATE AND LOCATION July 11-14, 2016 School of Medicine and Health Sciences, the George Washington University, Washington DC

CREDITS 3 ECTS

TUITION FEE AND REGISTRATION • CHF 2’000.– (standard course fee) • CHF 1’400.– (reduced fee) for university employees and non for profit organizations

FLIGHT AND HOTEL Have to be booked individually, directions regarding hotels close by the campus will be provided

REGISTRATION

ECPM University of Basel Klingelbergstrasse 61 CH-4056 Basel, Switzerland www.ecpm.ch

The George Washington University School of Medicine and Health Sciences 2100 Pennsylvania Avenue US-Washington, DC 20037 www.smhs.gwu.edu

DAY 1

MONDAY, JULY 11

Time

Session

08:00 – 09:00

Registration, breakfast and networking

09:00 – 09:15

Welcome and course overview

09:15 – 10:10

Advocating for Reasonable Regulations

10:00 – 10:30

Interactive Exercise: Sharing Professional Expertise

10:30 – 11:00

Break

11:00 – 11:45

Driving Biomedical Innovation by Advancing Regulatory Science at FDA

11:45 – 01:15

Lunch

01:15 – 02:00

Health Care Simulation to Advance Safety, Responding to Ebola and Other Threats

02:00 – 02:45

How to Prepare and Conduct a Successful Meeting with Health Authorities

02:45 – 03:15

Accessing Competitive Intelligence under the Freedom of Information Act

03:00 – 03:15

Break

03:15 – 04:00

Why Pharma Companies should care about social media

04:00 – 05:00

Dangerous Documents: Avoiding Land Mines in Your FDA Records and Emails

05:00 – 07:00

Network Reception Please note that the schedule may be subject to change

DAY 2

TUESDAY, JULY 12

Time

Session

09:30

Arrive White Oak Bldg 2, Clear security

10:00 – 10:30 Introduction to FDA 10:30 – 11:00 Overview of the Office of the Chief Scientist and Regulatory Science 11:00 – 11:15 Break 11:15 – 11:45

Overview of Minority Health

11:45 – 12:15 Current Issues in Drug Development 12:15

Departure to NIH

12:45

Arrive at the NIH, Security Screening, Walk to NLM Visitor Center

12:45 – 01:30 Lunch in Nobel Laureate Exhibit Hall 01:30 – 02:30 Tour at the National Library of Medicine 02:30 – 02:45

Travel to the NIH Clinical Center

02:45 – 03:45 Combined NIH Overview and Clinical Center Walking Tour 03:45

Departure to George Washington University

DAY 3

WEDNESDAY, JULY 13

Time

Session

08:30 – 09:30 Regulatory Writing: A practical toolkit 09:30 – 09:45 Break 09:45 – 10:30

510(k) Submissions -– What You Don’t Know Can Hurt You

10:30 – 11:15

First Experiences with the new EU Device Regulation: A notified body perspective

11:15 – 12:00

Current Challenges to Medical-Technology Innovation

12:00 – 01:00

Lunch

Time

Session

01:00 – 01:45

The Secrets to Effectively Handling FDA Inspections

01:45 – 02:30

Building and Sustaining a Culture of Quality in Tough Economic Times

02:30 – 03:30

Device Recall Process: Case Studies

03:30 – 03:45

Break

03:45 – 04:45

Case Study Safety Aspects in Drug Development

04:45 – 05:15

Round table discussion on case study

DAY 4

THURSDAY, JULY 14

Time

Session

08:30 – 09:15 Infectious Disease Epidemiology and Issues Around Vaccines 09:15 – 10:00

The Changing Climate of Health Care: Challenges and Opportunities

10:00 – 10:45

Regulating Health Care Quality in an Information Age (working title)

10:45 – 11:15 Break 11:15 – 12:00 Drugs and Payers: Pharma Policy 12:00 – 12:45 Trends in Health Care Policy 12:45 – 01:30

Session under discussion – details will follow soon

01:30

Closing remarks Please note that the schedule may be subject to change