Clinical Trials Essentials: An Intensive One-Week Course (register for the full week or half day sessions-2017-03-12

Event Information
Event Name: 
Clinical Trials Essentials: An Intensive One-Week Course (register for the full week or half day sessions
Event Date: 
03/12/2017 - 8:30am
Event Location: 
SF Bay Area: Foster City Crowne Plaza
Event Details
Event Type: 
Event Details: 

PBSS Workshop, Monday, March 12, 2017

Topic: “Clinical Trials Essentials: An Intensive One-Week Course (register for the full week or half day sessions)”
Speakers: Edward Rozhon, Mike Huston, Narinder Singh, Gerri O'Riordan, Pete Shabe, Savita Sinha, Clarisa Tate, Frances Ann McKenney
Date and Time: 3/12/2018, 8:30-17:30
Registration fee (USD): One-week full course: $1865; Mon AM: Drug Development Process: $200; Mon PM: Science of Clinical Trials Design: $200; Tue AM: GCP & ICH Investigator & Clinical Research Site: $200; Tue PM: Global Clinical Trials Perspective & Applied Statistics in Clinical Trials: $200; Wed AM: Monitoring Clinical Trials: $200; Wed PM: Medical Devices: $200; Thur AM: Clinical Data Management: $200; Thur PM: Clinical QA/Compliance Audits and the FDA: $200; Fri AM: Good Manufacturing Practices and the Transition to Full Scale Manufacturing: $200; Fri PM: Business of Clinical Research; Study Site Perspective: $200;
Location: SF Bay Area: Foster City Crowne Plaza
Registration deadline:3/9/2018 (it will close sooner if the seating cap is reached)

Topic Description
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.