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Workshop
Clinical Trials Essentials: An Intensive One-Week Course (register for the full week or half day sessions)
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
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Major players in drug development
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Assay development and discovery of new medical entities
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Non clinical and clinical development of new drugs
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History and regulatory oversight of FDA
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Structure of Phase I, II, & III clinical trials
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FDA review of New Drug Application
Monday March 16, 2020 – 1:30—3:00 pm Study Site Perspective 1.5 hours – Gerri O’Riordan
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Translational research in an academic center: fundamental strengths and weaknesses
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Research Process and Operations management as the success of a trial
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Essential conversations between academia, biomedical and pharmaceutical companies, venture capitalists and consultants
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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
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The role statistics plays in clinical research
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Basic data summarization techniques
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Estimation and Hypothesis Testing Introduction
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Estimation and Confidence Intervals
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Statistical Hypothesis Testing
Tuesday March 17, 2020 – 8:30 am—12:30 pm GCP & ICH Investigator & Clinical Research Site 4 hours – Jeaneen Wallis
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Historical and legislative roads to Good Clinical Practices (GCP)
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Principles of GCP and the research-care conflict
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Role of various stakeholders in Clinical Trials
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Elements of informed consent
Tuesday March 17, 2020 – 1:30 pm—5:30 pm Medical Devices, An Overview 4 hours – Clarisa Tate
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What is a medical device, a general overview of regulations
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Medical devices regulatory pathways: 510(k), PMA, and HDE
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Medical device clinical trials: Focus on Investigational Device Exemptions
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Post-market surveillance: Focus on 522, complaints, and recalls
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Globalization and changing regulatory environment
Wednesday March 18, 2020 – 8:30 am—12:30 pm Monitoring Clinical Trials 4 hours – Savita Sinha
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Review the basic regulatory requirements of monitoring a clinical research study
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Describe the tasks that should be performed before, during, and after a monitoring visit
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Learn how to track all key parameters involved in monitoring a site
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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
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Phases of drug development
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Objectives of clinical studies
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Basic clinical trials designs
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Underlying science for clinical trials designs
Thursday March 19, 2020 – 8:30 am—12:30 pm Clinical Data Management 4 hours – Amanda Whalen
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Key data management activities for study startup, conduct, and closeout
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Regulations applicable to data management activities
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Clinical data management systems and electronic data capture (EDC)
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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
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Qualifications needed for GXP auditors and FDA Inspectors
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Objectives of sponsor audits and regulatory inspections
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Similarities and differences between sponsor audits and regulatory inspections
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General approach to hosting an audit or inspection
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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
Friday March 20, 2020 – 10:15 am—12:30 pm Business of Clinical Research 2 hours – Maria Filippou-Frye
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The Market Players – Pharma, Biotech, Contract Research Organizations (CROs)
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Cost of Doing Business – Cost of conducting clinical research
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Outsourcing and CROs – It costs money to make money
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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
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Good Manufacturing Practices (GMP) for drugs
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GMP for biologics and related products, including Good Tissue Practices
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Considerations for Quality Systems
2024-04-26, [In-Person] Oncology Clinical Dose Optimization in Light of FDA Project Optimus
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2024-05-06, [In-Person] Human Mass Balance and Metabolite Profiling Studies: Strategies, Technical Approaches, Regulatory Guidance, Applications and Case Studies
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2024-05-13, [Free Online] Highlights of 2023 FDA Drug Approvals
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2024-05-21, [In-Person] Nonclinical Safety Studies for IND and NDA Filing for Small Molecules: Nuts, Bolts and Best Practices
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2024-05-30, [Free Online Workshop] Career Transition for Research Scientists: Career Overview, Project Management and Regulatory Affairs (jointly with BioPharmaPM and RAPS-SF)
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2024-06-13, [In-Person] CMC Strategies and Activities for IND and NDA Filing for Small Molecules: Nuts, Bolts and Best Practices
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2024-06-20, Alzheimer's Disease: untangling what we thought we knew and future Precision Medicine Diagnostics and Therapeutics
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2024-07-24, [Free Online] The Science and Stories of Promising Biotech Startups: Symposium No.6
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2024-09-10, [In-Person] Rethinking Translational PK/PD and Human Dose Projections for Novel Therapeutic Modalities: Covalent Inhibitors, PROTACs, Molecular Glues, ADCs, Ocular and Neuro delivery, Vaccines, Bispecifics, Cell and Gene Therapies
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2024-09-20, [In-Person] Non-clinical safety assessments of biologics and novel modalities for IND/NDA Filing: Nuts, Bolts and Best Practices
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2024-10-10, [In-Person] Regulatory Global Submission: Strategies and Best Practices for FDA, EMA and PMDA
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