Speakers:
Organizers:
Date: 2020-03-16- 3/20/2020
Time: 12:30-17:00 Pacific Time
Registration fee: Full week - $1865; Each half-day session - $250
Location: Santa Clara, CA (3175 Bowers Avenue)
Major Sponsor:
Vendor show vendors registered to date:
Registration: http://www.PBSS.org
Registration deadline:2020-03-11  (it will close sooner if the seating cap is reached)

About the Topic

Course Outline

Monday March 16, 2020 – 8:30 am—12:30 pm
Drug Discovery and Development 4 hours – Edward Rozhon 

• Major players in drug development

• Assay development and discovery of new medical entities

• Non clinical and clinical development of new drugs

• History and regulatory oversight of FDA

• Structure of Phase I, II, & III clinical trials

• FDA review of New Drug Application 

Monday March 16, 2020 – 1:30—3:00 pm
Study Site Perspective 1.5 hours – Gerri O’Riordan

• Translational research in an academic center: fundamental strengths and weaknesses

• Research Process and Operations management as the success of a trial

• Essential conversations between academia, biomedical and pharmaceutical companies, venture capitalists and consultants

• Data Integrity and well-supported metrics (Case Studies)

Monday March 16, 2020 – 3:15 pm—5:30 pm
Applied Statistics in Clinical Trials 2.25 hours – Peter Shabe

• The role statistics plays in clinical research

• Basic data summarization techniques

• Estimation and Hypothesis Testing Introduction

• Estimation and Confidence Intervals

• Statistical Hypothesis Testing 

Tuesday March 17, 2020 – 8:30 am—12:30 pm
GCP & ICH Investigator & Clinical Research Site 4 hours – Jeaneen Wallis

• Historical and legislative roads to Good Clinical Practices (GCP)

• Principles of GCP and the research-care conflict

• Role of various stakeholders in Clinical Trials

• Elements of informed consent

Tuesday March 17, 2020 – 1:30 pm—5:30 pm
Medical Devices, An Overview 4 hours – Clarisa Tate

• What is a medical device, a general overview of regulations

• Medical devices regulatory pathways: 510(k), PMA, and HDE

• Medical device clinical trials: Focus on Investigational Device Exemptions

• Post-market surveillance: Focus on 522, complaints, and recalls

• Globalization and changing regulatory environment

Wednesday March 18, 2020 – 8:30 am—12:30 pm
Monitoring Clinical Trials 4 hours – Savita Sinha

• Review the basic regulatory requirements of monitoring a clinical research study

• Describe the tasks that should be performed before, during, and after a monitoring visit

• Learn how to track all key parameters involved in monitoring a site

• Know how to complete visit reports and follow-up on action items after each site visit 

Wednesday March 18, 2020 – 1:30 pm—5:30 pm
Science of Clinical Trials Design 4 hours – Romi Behbehanian

• Phases of drug development

• Objectives of clinical studies

• Basic clinical trials designs

• Underlying science for clinical trials designs

Thursday March 19, 2020 – 8:30 am—12:30 pm
Clinical Data Management 4 hours – Amanda Whalen

• Key data management activities for study startup, conduct, and closeout

• Regulations applicable to data management activities

• Clinical data management systems and electronic data capture (EDC)

• Working with contract research organizations (CROs) for data management

Thursday March 19, 2020 – 1:30 pm—5:30 pm
Clinical QA/Compliance Audits and the FDA 4 hours –Jeaneen Wallis

• Qualifications needed for GXP auditors and FDA Inspectors

• Objectives of sponsor audits and regulatory inspections

• Similarities and differences between sponsor audits and regulatory inspections

• General approach to hosting an audit or inspection 

• Types of findings that cause concern for auditors or inspectors

Friday March 20, 2020 – 8:30 am—10:00 am
Global Clinical Trials Perspective 1.5 hour – Jeaneen Wallis

• Trends in global clinical trials

• Role of FDA and local regulatory culture

Friday March 20,  2020 – 10:15 am—12:30 pm
Business of Clinical Research 2 hours – Maria Filippou-Frye

• The Market Players – Pharma, Biotech, Contract Research Organizations (CROs)

• Cost of Doing Business – Cost of conducting clinical research

• Outsourcing and CROs – It costs money to make money

• Innovative Ways to Reduce Cost – Business Strategies and Process Innovations

Friday March 20,  2020 – 1:30 pm—5:30 pm
Good Manufacturing Practices and Regulatory Trends 4 hours – Romi Behbehanian

• Good Manufacturing Practices (GMP) for drugs

• GMP for biologics and related products, including Good Tissue Practices

• Considerations for Quality Systems