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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: 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: UCSC-Extension, 3175 Bowers Ave, Santa Clara, CA
Major Sponsor:
Vendor show vendors registered to date:
Registration deadline:3/14/2018  (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.

2018-04-24, Regulatory Authority Inspection Preparation and Outcomes
2018-04-27, SOT-PBSS Joint Spring Symposium: Immuno-oncology: Opportunities, Therapeutic Approaches, and Safety Considerations
2018-05-22, Understanding and Overcoming High Clearance and Poor Bioavailability: Fundamentals, Investigations and Strategies for Drug Discovery
©Pharmaceutical & BioScience Society, International; Last Modified: 3/24/2018; Visited: 463; Admin Logon
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