Workshop
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
Organizers:
Date:
2018-03-12
Time:
8:30-17:30 Pacific Time
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: http://www.PBSS.org
Registration deadline:2018-03-14
(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.
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