WEBINARS

 

Clinical Research Trial Design and Management Regulatory Compliance Training - Live Webinars, Recordings & CDs

Hypothesis Testing, P-values and Inference: When Thinking like a Statistician Makes Sense

webinar-speaker   Elaine Eisenbeisz

webinar-time   90 Min

Product Id: 703552

This clinical research webinar will explore the reasoning that formulates null hypotheses and turns researchers’ hair gray. Attendees will learn the why and how of the scientific method and how to view the world with a statistician’s eyes. Also attendees will learn the possibilities and limitations of research questions and hypothesis development, how to interpret statistical findings with p-values, effect sizes, and confidence intervals.

Recording Available

* Per Attendee $349

 

How to Prepare a Standard Operating Procedure (SOP)?

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

Product Id: 705131

This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.

Recording Available

* Per Attendee $299

 

Surviving an FDA Sponsor Inspection - Training for Success

webinar-speaker   Stephen Schwartz

webinar-time   105 Min

Product Id: 704516

This training program will review a case study derived from actual inspections wherein FDA performed a sponsor site inspection having already audited three of the investigator sites. FDA was aware from these site audits of potential serious noncompliance issues. The course will also discuss Sponsor/CRO/investigator relationship issues from these three site audits.

Recording Available

* Per Attendee $429

 

Risk Based Monitoring for GCP Compliance

webinar-speaker   Laura Brown

webinar-time   60 Min

Product Id: 705052

This Webinar will help you how to ensure that your data and supporting documentation are in the appropriate format to comply with regulatory authority inspection. Risk based monitoring can contribute to better oversight and more efficient use of resources of clinical studies.

Recording Available

* Per Attendee $299

 

Processes & Effects of Immunogenicity to Biologics & the Screening Methodologies - 3 hour Virtual Training

webinar-speaker   Gwen Wise Blackman

webinar-time   180 Min

Product Id: 705019

This 3 hour virtual training will provide an overview of the concepts and types of immune responses elicited by biologics. The factors contributing to immunogenicity and impact on efficacy and safety will be identified. Validated screening and confirmatory methods that measure an immune response to a biologic during the various stages of development, clinical studies and post-approval surveillance will be discussed.

Recording Available

* Per Attendee $349

 

Extractables and Leachables in Early Phase Development

webinar-speaker   Wayland Rushing

webinar-time   60 Min

Product Id: 704517

This training program will offer insight into where extractables and leachables come from. Attendees will learn the regulatory expectations and trends for extractables and leachables in early phase development and learn which products may require E&L data in early phases. The program will also focus on how to design programs to meet the needs of early phase development – i.e. phase appropriate E&L programs.

Recording Available

* Per Attendee $279

 

Preparing Compliant eCTD Submissions: Are You Prepared for Upcoming FDA Mandate on e-Submissions?

webinar-speaker   Peggy Berry

webinar-time   60 Min

Product Id: 705349

This webinar will review the CTD format requirements including documentation and technical requirements for an eCTD submissions. It will help attendees prepare for implementing the FDA upcoming mandates on e-submissions.

Recording Available

* Per Attendee $10

 

Computer System Validation and Part 11 Compliance

webinar-speaker   Joy McElroy

webinar-time   60 Min

Product Id: 705427

This webinar will discuss in detail the requirements of 21 CFR part 11 and updated European Annex 11 regulation including requirements for local, SaaS, and cloud hosting. It will also offer techniques to implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds.

Recording Available

 

Bioavailability and Bioequivalence Studies submitted in NDAs and INDs

webinar-speaker   Stephanie Cooke

webinar-time   90 Min

Product Id: 705506

Attendees that need to perform bioavailability (BA) and bioequivalence (BE) studies for INDs, NDAs or for NDA supplements should attend this training. They will learn the requirements of such studies, per 21 CFR 320 and all other relevant regulatory documents.

Recording Available

* Per Attendee $279

 

Trial Master File and Clinical Data Management Regulated by FDA

webinar-speaker   Carolyn Troiano

webinar-time   60 Min

Product Id: 705360

This FDA compliance training will cover in detail the new requirements for trial master files including documents related to clinical trials that are required to be prepared, collected and maintained as part of the TMF.

Recording Available

* Per Attendee $249

 

Good Manufacturing Practices (GMPs) for Phase I Investigational Drugs / Clinical Studies

webinar-speaker   Peggy Berry

webinar-time   90 Min

Product Id: 705255

This webinar will help attendees understand differences between GMP requirements for early and later stage clinical development. It will explore and discuss ways to develop and implement strategies for early GMPs for phase I clinical studies.

Recording Available

 

Use of Electronic Health Record Data (EHR) in FDA regulated clinical investigations

webinar-speaker   Rachelle D Souza

webinar-time   60 Min

Product Id: 704906

This webinar will discuss FDA’s current recommendations on using electronic health records in prospective clinical investigations of human drugs, biologics, medical devices and combination products.

Recording Available

* Per Attendee $249

 

Compliance with Brexit's Impact on the Global Pharmaceutical industry

webinar-speaker   Laura Brown

webinar-time   60 Min

Product Id: 705047

Pharmaceutical companies will need to develop strategies for their drug programmes to deal with Brexit. This webinar will provide an essential understanding to help develop a strategy for managing Brexit.

Recording Available

 

Phase I First-in-Man Studies: What is Special About How and Where These Trials are Conducted?

webinar-speaker   Charles H Pierce

webinar-time   90 Min

Product Id: 704842

This webinar will discuss the expectations of Phase 1 'First-in-Man' clinical studies, contrast the testing of pharmacokinetics and pharmacodynamics, differentiate safety testing in Phase 1 and 3 and describe the process of establishing the starting dose.

Recording Available

* Per Attendee $50

 

Compliance with the New EU Clinical Trial Regulation

webinar-speaker   Laura Brown

webinar-time   60 Min

Product Id: 705007

This webinar will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU.

Recording Available

 

Compliance with the New ICH GCP revised 2 Guidelines

webinar-speaker   Laura Brown

webinar-time   60 Min

Product Id: 704989

This New ICH GCP E6 Revision 2 changes will cover those new requirements for running clinical trials, evaluate the changes and discuss how to implement these for sponsors, CROs and study sites. This session will enable you to meet the new international GCP standard to ensure the acceptance of clinical trial data by the regulatory authorities internationally including the European Union (EU), Japan, the United States, Canada and Switzerland.

Recording Available

 

Quality Assurance at the (Clinical Research) Site: How to Develop a Manageable Plan

webinar-speaker   Jennifer Holcomb

webinar-time   60 Min

Product Id: 702406

This clinical compliance training will help attendees understand how they can develop and implement a Quality Assurance (QA) program at their clinical research site that ensures the staff are properly trained and that the research is carried out in accordance with regulatory expectations.

Recording Available

* Per Attendee $249

 

Defining and Managing Protocol Deviation/Violation/Exception

webinar-speaker   Calin Popa

webinar-time   90 Min

Product Id: 704953

This webinar will teach you how to downsize the risk of noncompliance during the development of a clinical trial by helping you to understand, correct and prevent potential protocol deviations/violations.

Recording Available

 

Clinical Trial auditing - Identifying risks and building a more compliant and successful trial

webinar-speaker   Calin Popa

webinar-time   90 Min

Product Id: 701860

Learn how to successfully pass a clinical trial audit, how to prepare for it, where and how to identify the non compliance. Know FDA inspection strategy to identify areas of common deficiency.

Recording Available

* Per Attendee $249

 

Creating Effective SOPs for Regulatory Compliance

webinar-speaker   Henry Urbach

webinar-time   60 Min

Product Id: 702999

This FDA documentation webinar will explain the regulatory expectations for, and the proper design and maintenance of effective and compliant standard operating procedures (SOPs).

Recording Available

* Per Attendee $279

 

 

 

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