Speakers: Edward Rozhon, Mike Huston, Narinder Singh, Gerri O\’Riordan, Pete Shabe, Savita Sinha, Clarisa Tate, Frances Ann McKenney
Organizers: 
Date: 3/12/2018
Time: 8:30-17:30
Registration fee (USD): One-week full course: $1865; Mon AM: Drug Development Process: $250; Mon PM: Science of Clinical Trials Design: $250; Tue AM: GCP & ICH Investigator & Clinical Research Site: $250; Tue PM: Global Clinical Trials Perspective & Applied Statistics in Clinical Trials: $250; Wed AM: Monitoring Clinical Trials: $250; Wed PM: Medical Devices: $250; Thur AM: Clinical Data Management: $250; Thur PM: Clinical QA/Compliance Audits and the FDA: $250; Fri AM: Good Manufacturing Practices and the Transition to Full Scale Manufacturing: $250; Fri PM: Business of Clinical Research; Study Site Perspective: $250;
Location: SF Bay Area: Foster City Crowne Plaza or UCSC Santa Clara (TBD)
Major Sponsor: 
Vendor show vendors registered to date: 
Registration: https://www.PBSS.org
Registration deadline:3/9/2018  (it will close sooner if the seating cap is reached)

About the Topic

Clinical Trials Essentials: An Intensive One-Week Course

A joint course between UCSC Extension Silicon Valley and Pharmaceutical and Bio ScienceSociety — San Francisco

Monday March 12, 2018 – 8:30 am—12:30 pm

Drug Development Process 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 12, 2018 – 1:30 pm—5:30 pm

Science of Clinical Trials Design 4 hours – Mike Huston

• Phases of drug development
• Objectives of clinical studies
• Basic clinical trials designs
• Underlying science for clinical trials designs.

Tuesday March 13, 2018 – 8:30 am—12:30 pm

GCP & ICH Investigator & Clinical Research Site 4 hours – Narinder Singh

• 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 13, 2018 – 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).

Tuesday March 13, 2018 – 3:15 pm—5:30 pm

Applied Statistics in Clinical Trials 2.25 hours – Pete Shabe

• The role statistics plays in clinical research
• Basic data summarization techniques
• Estimation and Hypothesis Testing Introduction
• Estimation and Confidence Intervals
• Statistical Hypothesis Testing.

Wednesday March 14, 2018 – 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 14, 2018 – 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.

Thursday March 15, 2018 – 8:30 am—12:30 pm

Clinical Data Management 4 hours – Instructor TBA

• 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 15, 2018 – 1:30 pm—5:30 pm

Clinical QA/Compliance Audits and the FDA 4 hours – Frances Ann McKenney

• 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 16, 2018 – 8:30 am—12:30 pm

Good Manufacturing Practices and regulatory trends 4 hours – Narinder Singh

• Good Manufacturing Practices (GMP) for drugs
• GMP for biologics and related products, including Good Tissue Practices
• Considerations for Quality Systems.

Friday March 16, 2018 – 1:30 pm—3:00 pm

Global Clinical Trials Perspective 1.5 hour – Narinder Singh

• Trends in global clinical trials.
• Role of FDA and local regulatory culture.

Friday March 16, 2018 – 3:15 pm—5:30 pm

Business of Clinical Research 2 hours – Mike Huston

• 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.