Gene Therapy – August 3, 2015

Posted on Aug 3rd, 2015

Speaker Topic Date Location Jenna Hess, MS Gene Therapy August 3, 2015 Midwest Area Biosafety Network (MABioN) Symposium- Chicago,…

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Recommendations for Improving Informed Consent: Recent Agency Guidance and Hot Topics – July 23, 2015

Posted on Jul 23rd, 2015

Speaker Topic Date Location David Borasky, MPH, CIP Recommendations for Improving Informed Consent: Recent Agency Guidance and Hot…

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Special Considerations Regarding Adult and Pediatric Populations – July 23, 2015

Posted on Jul 23rd, 2015

Speaker Topic Date Location David Forster, JD, MA, CIP Special Considerations Regarding Adult and Pediatric Populations July 23,…

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Using External Resources to Enhance EHS Programs – July 22, 2015

Posted on Jul 22nd, 2015

Speaker Topic Date Location Chris Jenkins, PhD, MPH, RBP, CHMM Using External Resources to Enhance EHS Programs July 22, 2015 CSHEMA…

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Biosafety Training – July 18, 2015

Posted on Jul 18th, 2015

Speaker Topic Date Location Chris Jenkins, PhD, MPH, RBP, CHMM Biosafety Training July 18, 2015 CSHEMA 2015 Conference- Washington,…

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Biosafety Institutions: An Overview for EHS Managers – July 17, 2015

Posted on Jul 17th, 2015

Speaker Topic Date Location Chris Jenkins, PhD, MPH, RBP, CHMM Biosafety Institutions: An Overview for EHS Managers July 17,…

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Review of CIM Research by an IRB: Standards and Expectations – July 8, 2015

Posted on Jul 8th, 2015

Speaker Topic Date Location Stuart Horowitz, PhD, MBA Review of CIM Research by an IRB: Standards and Expectations July 8, 2015 Global…

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A Systematic Approach to Study Start-Up – June 19, 2015

Posted on Jun 19th, 2015

Speaker Topic Date Location Stuart Horowitz, PhD, MBA A Systematic Approach to Study Start-Up June 19, 2015 Drug Information…

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Centralized Ethics: How a Unique Partnership Between a CRO and an IRB is Changing the Regulatory and Ethics Review Process – June 18, 2015

Posted on Jun 18th, 2015

Speaker Topic Date Location Tim Schuckman Centralized Ethics: How a Unique Partnership Between a CRO and an IRB is Changing the…

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Site-Specific Risk Management for Human Gene Therapy Trials – June 17, 2015

Posted on Jun 17th, 2015

Speaker Topic Date Location Chris Jenkins, PhD, MPH, RBP, CHMM Site-Specific Risk Management for Human Gene Therapy Trials June 17,…

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Is Facebook Hurting Your Trial? Social Media and the Introduction of Bias in Clinical Studies – June 17, 2015

Posted on Jun 17th, 2015

Speaker Topic Date Location Lindsay McNair,  MD, MPH, MSB Is Facebook Hurting Your Trial? Social Media and the Introduction of Bias in…

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Biosafety: Navigating the Institutional Biosafety Committee Roadblock – June 17, 2015

Posted on Jun 17th, 2015

Speaker Topic Date Location Chris Jenkins, PhD, MPH, RBP, CHMM Biosafety: Navigating the Institutional Biosafety Committee…

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Overview of Human Gene Therapy and Research Compliance Considerations – June 11, 2015

Posted on Jun 11th, 2015

Speaker Topic Date Location Chris Jenkins, PhD, MPH, RBP, CHMM Overview of Human Gene Therapy and Research Compliance…

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IRB Considerations for Clinical Monitors in the Conduct of Clinical Research – June 9, 2015

Posted on Jun 9th, 2015

Speaker Topic Date Location Troy Brinkman and Kurt Douglass IRB Considerations for Clinical Monitors in the Conduct of Clinical…

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Challenges in IBC Review of Multi-Site Clinical Trials – June 8, 2015

Posted on Jun 8th, 2015

Speaker Topic Date Location Chris Jenkins, PhD, MPH, RBP, CHMM Challenges in IBC Review of Multi-Site Clinical Trials June 8,…

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Human Gene Transfer, Institutional Biosafety Committees, and Biological Materials Oversight: Past, Present, and Future for Clinical Research – June 1, 2015

Posted on Jun 1st, 2015

Speaker Topic Date Location Chris Jenkins, PhD, MPH, RBP, CHMM Human Gene Transfer, Institutional Biosafety Committees, and Biological…

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Overview of Human Gene Therapy & Research Compliance Considerations – May 29, 2015

Posted on May 29th, 2015

Speaker Topic Date Location Chris Jenkins, PhD, MPH, RBP, CHMM Overview of Human Gene Therapy & Research Compliance…

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International Perspective: Achieving a Robust Human Research Protection Program – May 20, 2015

Posted on May 20th, 2015

Speaker Topic Date Location David Borasky, MPH, CIP International Perspective: Achieving a Robust Human Research Protection Program May…

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Negotiating Contracts That Protect Human Research Participants – May 20, 2015

Posted on May 20th, 2015

Speaker Topic Date Location David Forster, JD, MA, CIP Negotiating Contracts That Protect Human Research Participants May 20,…

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Social Media: Friend or Foe – May 19, 2015

Posted on May 19th, 2015

Speaker Topic Date Location Lindsay McNair, MD, MPH, MSB Social Media: Friend or Foe May 19, 2015 MAGI East- Alexandria,…

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IRB Review of Device Studies – May 19, 2015

Posted on May 19th, 2015

Speaker Topic Date Location Jeffrey Cooper, MD, MMM IRB Review of Device Studies May 19, 2015 MAGI East- Alexandria,…

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Emerging Issues in Human Subjects Protection – May 18, 2015

Posted on May 18th, 2015

Speaker Topic Date Location David Forster, JD, MA, CIP Emerging Issues in Human Subjects Protection May 18, 2015 MAGI East-…

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Regulatory Myths – May 18, 2015

Posted on May 18th, 2015

Speaker Topic Date Location Jeffrey Cooper, MD, MMM Regulatory Myths May 18, 2015 MAGI East- Alexandria,…

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Single IRB Review for Multisite Studies: Promoting Quality Review and Oversight – May 5, 2015

Posted on May 5th, 2015

Speaker Topic Date Location David Borasky, MPH, CIP Single IRB Review for Multisite Studies: Promoting Quality Review and Oversight May…

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Current Topics in US Regulation – April 30, 2015

Posted on Apr 30th, 2015

Speaker Topic Date Location David Borasky, MPH, CIP Current Topics in US Regulation April 30, 2015 Canadian Association of Research…

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How to Seamlessly Transfer Your Study to Another IRB – April 27, 2015

Posted on Apr 27th, 2015

Speaker Topic Date Location Stuart Horowitz, PhD, MBA and Troy Brinkman How to Seamlessly Transfer Your Study to Another IRB April 27,…

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Use of Standard Operating Procedures to Streamline IRB Submissions – April 26, 2015

Posted on Apr 26th, 2015

Speaker Topic Date Location Jeffrey Cooper, MD, MMM and Troy Brinkman Use of Standard Operating Procedures to Streamline IRB…

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Fundamentals of Clinical Study Design – April 24, 2015

Posted on Apr 24th, 2015

Speaker Topic Date Location Lindsay McNair, MD, MPH, MSB Fundamentals of Clinical Study Design April 24, 2015 Association of Clinical…

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The IRB Ecosystem of a Busy Clinical Research Institution – April 21, 2015

Posted on Apr 21st, 2015

Speaker Topic Date Location Stuart Horowitz, PhD, MBA and Charlie Eibeler The IRB Ecosystem of a Busy Clinical Research…

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IRB Requirements for the CRA Monitor – April 17, 2015

Posted on Apr 17th, 2015

Speaker Topic Date Location Troy Brinkman and Kurt Douglass IRB Requirements for the CRA Monitor April 17, 2015 SoCRA Human Research…

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As the Role of Patients in Clinical Research Changes from “Subject” to True Participant, What Implications Does this Have on Informed Consent? – March 17, 2015

Posted on Mar 17th, 2015

Speaker Topic Date Location Lindsay McNair As the Role of Patients in Clinical Research Changes from "Subject" to True Participant, What…

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ReferralPlus – From Pilot to Production – March 16, 2015

Posted on Mar 16th, 2015

Speaker Topic Date Location Lisa LaLuna ReferralPlus - From Pilot to Production March 16, 2015 Patients as Partners- Philadelphia,…

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How to Use a Central IRB – March 12, 2015

Posted on Mar 12th, 2015

Speaker Topic Date Location David Forster, JD, MA, CIP How to Use a Central IRB March 12, 2015 Office of Human Research Protections…

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The Three I’s and Biosecurity – March 4, 2015

Posted on Mar 4th, 2015

Speaker Topic Date Location Chris Jenkins, PhD, MPH, RBP, CHMM The Three I's and Biosecurity March 4, 2015 Massachusetts Society for…

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Points Learned From Aerosol and Droplet Transmissions, & How That Understanding Evolved Over the Current Ebola Crisis – February 19, 2015

Posted on Feb 19th, 2015

Speaker Topic Date Location Chris Jenkins, PhD, MPH, RBP, CHMM Points Learned From Aerosol and Droplet Transmissions, & How That…

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A Paperless Clinical Trial – How we did it – February 10, 2015

Posted on Feb 10th, 2015

Speaker Topic Date Location Lisa LaLuna and Brian Mundy A Paperless Clinical Trial - How we did it February 10, 2015 DPharm Europe-…

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SitePortal – Leveraging site portal technology to improve productivity and enrollment – January 27, 2015

Posted on Feb 26th, 2015

Speaker Topic Date Location Lisa LaLuna SitePortal - Leveraging site portal technology to improve productivity and enrollment January…

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Improving IRB Processes Through Value Stream Mapping and Kaizen Events: A Case Study – December 7, 2014

Posted on Feb 26th, 2015

Speaker Topic Date Location Michael Willis, CIP and Sherry Seabock Improving IRB Processes Through Value Stream Mapping and Kaizen…

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Designing and Implementing a Quality Management System – December 7, 2014

Posted on Feb 26th, 2015

Speaker Topic Date Location Dawn Pope, CIP Designing and Implementing a Quality Management System (Poster) December 7, 2014 Public…

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IRB Management: Innovative Ways to Foster Accountability and Integrity – December 7, 2014

Posted on Feb 26th, 2015

Speaker Topic Date Location Yvonne Higgins, CIP IRB Management: Innovative Ways to Foster Accountability and Integrity December 7,…

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Is Facebook Hurting Your Study? Ethical and Study Integrity Concerns when Participants Use Social Media – December 7, 2014

Posted on Feb 26th, 2015

Speaker Topic Date Location Lindsay McNair, MD, MPH, MSB Is Facebook Hurting Your Study? Ethical and Study Integrity Concerns when…

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“Lean” Thinking for IRB Process Improvement – December 7, 2014

Posted on Feb 26th, 2015

Speaker Topic Date Location Yvonne Higgins, CIP "Lean" Thinking for IRB Process Improvement December 7, 2014 Public Responsibility In…

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Scientific Aspects of Clinical Study Design: A Primer for Non-Scientists – December 7, 2014

Posted on Feb 26th, 2015

Speaker Topic Date Location Lindsay McNair, MD, MPH, MSB Scientific Aspects of Clinical Study Design: A Primer for…

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Institutional IRB Performance Benchmarking Metrics – December 7, 2014

Posted on Feb 26th, 2015

Speaker Topic Date Location Jeffrey A. Cooper, MD, MMM and Stuart Horowitz, PhD, MBA Institutional IRB Performance Benchmarking…

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A Dialogue with SACHRP – December 7, 2014

Posted on Feb 26th, 2015

Speaker Topic Date Location David Borasky, MPH, CIP and David Forster, JD, MA, CIP A Dialogue with SACHRP December 7, 2014 Public…

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Aligning Institutions and Research Sponsors for the Efficient Conduct of Clinical Trials – December 6, 2014

Posted on Feb 26th, 2015

Speaker Topic Date Location Stuart Horowitz, PhD, MBA and Nicholas Slack, MBE Aligning Institutions and Research Sponsors for the…

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Unanticipated Problems and Adverse Events: A Practical Approach for IRBs – December 6, 2014

Posted on Feb 26th, 2015

Speaker Topic Date Location Jeffrey A. Cooper, MD, MMM Unanticipated Problems and Adverse Events: A Practical Approach for…

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The Role of Study Partners in Dementia Research and Its Implications for IRBs – December 6, 2014

Posted on Feb 26th, 2015

Speaker Topic Date Location Yvonne Higgins, MS, CIP The Role of Study Partners in Dementia Research and Its Implications for…

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IRB Chairs Forum: A Structured Discussion for Experienced IRB Chairs – December 6, 2014

Posted on Feb 26th, 2015

Speaker Topic Date Location Glenn Veit, JD, CIP IRB Chairs Forum: A Structured Discussion for Experienced IRB Chairs December 6,…

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Aligning IRB Review with Community Cultural Ethics and Standards – December 5, 2014

Posted on Feb 26th, 2015

Speaker Topic Date Location David Borasky, MPH, CIP Aligning IRB Review with Community Cultural Ethics and Standards December 5,…

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You’ll Know It When You See It: Defining ‘Human Subjects Research’ – December 5, 2014

Posted on Feb 26th, 2015

Speaker Topic Date Location David Forster, JD, MA, CIP You'll Know It When You See It: Defining 'Human Subjects Research' December 5,…

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Fundamentals of Clinical Research and Study Design – December 4, 2014

Posted on Feb 26th, 2015

Speaker Topic Date Location Lindsay McNair, MD, MPH, MSB Fundamentals of Clinical Research and Study Design December 4, 2014 Public…

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Navigating the IRB Process – November 11, 2014

Posted on Feb 26th, 2015

Speaker Topic Date Location Jeffrey A. Cooper, MD, MMM Navigating the IRB Process November 11,…

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Emerging Issues in Human Subjects Protection – November 10, 2014

Posted on Feb 26th, 2015

Speaker Topic Date Location David Forster, JD, MA, CIP Emerging Issues in Human Subjects Protection November 10,…

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IRB Best Practices – November 9, 2014

Posted on Feb 26th, 2015

Speaker Topic Date Location Troy Brinkman, JD, MA, CIP and Rebecca Clark, BBA IRB Best Practices November 9,…

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Biosafety: Understanding and Maximizing the Institutional Biosafety Committee – October 21, 2014

Posted on Feb 26th, 2015

Speaker Topic Date Location Chris Jenkins, PhD, MPH, RBP, CHMM Biosafety: Understanding and Maximizing the Institutional Biosafety…

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Adult Learning Styles for Electronic Research Compliance Training – October 18, 2014

Posted on Feb 26th, 2015

Speaker Topic Date Location Jeffrey A. Cooper, MD, MMM Adult Learning Styles for Electronic Research Compliance Training October 18,…

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Biosafety Considerations with Human Gene Transfer – October 3, 2014

Posted on Feb 26th, 2015

Speaker Topic Date Location David Emery, PhD Biosafety Considerations with Human Gene Transfer October 3, 2014 57th Annual American…

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Key Considerations for Efficient Study Designs in Early Stage Development and Proof-of-Concept Studies – September 16, 2014

Posted on Feb 26th, 2015

Speaker Topic Date Location Kathy Chase, PharmD Key Considerations for Efficient Study Designs in Early Stage Development and…

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Engaging Patients Via Data Sharing – September 16, 2014

Posted on Feb 26th, 2015

Speaker Topic Date Location Lindsay McNair, MD, MPH, MSB Engaging Patients Via Data Sharing September 16, 2014 CenterWatch/iiBIG 2nd…

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Disrupting Trial Patient Compensation – September 12, 2014

Posted on Feb 26th, 2015

Speaker Topic Date Location Stuart Horowitz, PhD, MBA Disrupting Trial Patient Compensation September 12, 2014 Disruptive Innovations…

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2013 IBC Practices Survey Results and Conclusions – July 25, 2014

Posted on Jul 25th, 2014

Speaker Topic Date Location Chris Jenkins, PhD, MPH, RBP, CHMM 2013 IBC Practices Survey Results and Conclusions July 25, 2014 Campus…

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Human Gene Therapy: Biosafety to Bedside – June 15, 2014

Posted on Jan 22nd, 2014

Speaker Topic Date Location Chris Jenkins, PhD, MPH, RBP, CHMM Human Gene Therapy: Biosafety to Bedside June 15, 2014 Drug Information…

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Accelerating Research in a Large Health Care System: Streamlining Research Review and Study Initiation – June 15, 2014

Posted on Jan 22nd, 2014

Speaker Topic Date Location Stuart Horowitz, PhD, MBA Accelerating Research in a Large Health Care System: Streamlining Research Review…

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Improving Communication in the Informed Consent Process: The Advantages of eConsent – June 15, 2014

Posted on Jan 22nd, 2014

Speaker Topic Date Location Lindsay McNair, MD, MPH, MSB Improving Communication in the Informed Consent Process: The Advantages of…

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Human Gene Transfer, Institutional Biosafety Committees, and Biological Materials Oversight: Past, Present and Future for Clinical Research – June 4, 2014

Posted on Jan 9th, 2014

Speaker Topic Date Location Chris Jenkins, PhD, MPH, RBP, CHMM Human Gene Transfer, Institutional Biosafety Committees, and Biological…

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Human Research Protections 101 – June 1, 2014

Posted on Jan 9th, 2014

Speaker Topic Date Location Jeffrey A. Cooper, MD, MMM Human Research Protections 101 June 01, 2014 Health Care Compliance…

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Establishing Fair Patient Compensation – March 4, 2014

Posted on Jan 7th, 2014

Speaker Topic Date Location Stuart Horowitz, PhD, MBA Establishing Fair Patient Compensation March 04, 2014 Patients as Partners-…

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The Challenges of Review and Oversight of Multicenter Cancer Studies : Challenges and Successes in Using Central IRBs or Single IRBs of Record – February 24, 2014

Posted on Jan 7th, 2014

Speaker Topic Date Location David Forster, JD, MA, CIP The Challenges of Review and Oversight of Multicenter Cancer Studies :…

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IBC Trends and Human Gene Transfer Considerations – March 1, 2014

Posted on Jan 7th, 2014

Speaker Topic Date Location Chris Jenkins, PhD, MPH, RBP, CHMM IBC Trends and Human Gene Transfer Considerations March 01,…

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Mergers & Acquisitions in the Clinical Research Sector – January 27, 2014

Posted on Jan 6th, 2014

Speaker Topic Date Location Donald A. Deieso, PhD Mergers & Acquisitions in the Clinical Research Sector January 27,…

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Institutional Biosafety Committee Trends and Human Gene Transfer Considerations – January 24, 2014

Posted on Jan 6th, 2014

Speaker Topic Date Location Chris Jenkins, PhD, MPH, RBP, CHMM Institutional Biosafety Committee Trends and Human Gene Transfer…

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