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Drug Safety Webinars - Archived

Drug Safety, uses technologies developed to measure and minimize adverse drug reactions. Webinars currated under the term, drug safety on this page range from benefit-risk assessments and post-marketing studies, to product labeling and adverse event reporting. The drug safety webinars listed here are recordings of past events. Simply register, for free, for any webinar by clicking the download archive button on each webinar page. If drug safety is to broad a term, don’t forget, you can search our webinar catalog using the search bar, or, if you’re looking for something more specific browse through our other topics.

  Synopsis Webinar Title Date

LifeScience - This webinar will share both design and methodology guidance in Non-GLP Toxicology studies in both NHPs and rodent models
Speakers: Dr. Keefe Chng, Chief Scientific Officer and Site Head, Crown Bioscience Louisiana (CBLA, Inc.)
Dr. Judith Gorski, Global Director of Scientific Engagement, Crown Bioscience Inc.
How to Maximize Your Non-GLP Toxicology Studies: A Guide for Optimal Design and Methodology Jul 26, 2017

LifeScience -  This webinar will include case studies of how market authorization holders and CROs are becoming partners of choice in the ever changing world of pharmacovigilance outsourcing
Speakers: Sukrit Singh, Associate Director, CRM, Bioclinica, Inc.
Dr. Ayesha Hussain, Associate Director, CRM, Bioclinica, Inc.
Outsourcing Pharmacovigilance: Pros and Cons and Lessons Learned Jul 25, 2017

LifeScience - In this webinar, the speaker will present vascular and neural complications in rodent models of obesity and type 2 diabetes. Specifically, he will present the characterization of peripheral neuropathy in translational animal models such as the ZDSD rat
Speaker: Dr. Mark Yorek, Professor of Medicine, University of Iowa and Associate Chief of Staff, Iowa City VA
Vascular and Neural Complications in Rodent Models of Obesity and Type 2 Diabetes Jul 12, 2017

LifeScience - Find out how the use of information technology for drug safety has evolved over the last decade in line with changing demands from the business
Speakers Andrew Mitchell, Director of Life Sciences, Synchronoss
Kapil Kedia, Founder & CEO, SyNRG Solutions Technologies
Pharmacovigilance Oversight – Best Practices for Safety IT Jun 14, 2017

LifeSciences -  Extensive prior studies have shown strong positive effects for targets and negative effects for acquirers but, they’ve have focused on measuring value creation from individual deals, not a firm’s overall programs of activity and performance over longer time periods
Speaker: Guy Henninger, Senior Life Sciences Executive, Intralinks
Biopharma Deal Making: Lessons Learnt from Cass Business School’s Study of Strategic Deals and Corporate Portfolio Management Nov 15, 2016

LifeSciences -  This webinar will showcase the results of Comprehend’s 2016 ClinOps ICH E6(R2) survey and its impact on the CRO/Sponsor relationship
Speakers: Bruno Gagnon, B Pharm, MSc, Clinical Intelligence Expert
Matt McKinney, Clinical Intelligence Expert, Comprehend Systems
ICH E6(R2) Benchmark Survey: Essential Elements of Compliant CRO Oversight Oct 27, 2016

LifeSciences - The speaker will takes us along a journey with lessons learnt from both an organizational and personal perspective
Speaker: Ed Tucker, Senior Vice President for Medical Safety, Quality and Compliance, Acerta (a majority owned company of AstraZeneca)
Drug Safety in a Startup Biotech Sep 15, 2016

LifeSciences - In this webinar, the speaker will discuss upcoming changes in global drug safety regulatory requirements and will demonstrate how Bioclinica's drug safety regulatory intelligence tool, RITrace, can improve efficiencies and help you remain compliant
Speaker: Nicole Baker, EEA QPPV, Director Drug Safety, Bioclinica, Inc.
Using the Cloud to Meet Pharmacovigilance Requirements and Maintain Global Compliance Aug 10, 2016

LifeSciences - End-to-end safety solutions need to encompass the required service, product and technology components in order to stand up to the challenges
Speaker: Francois Audibert, Vice President, Global Consulting Practice, Bioclinica, Inc.
Finding the Right End-to-End Safety Solution for Your Needs Jul 21, 2016

LifeSciences - This case study details how one successful Clinical Operations team automated their next generation risk and centralized monitoring program
Speakers: Ken Wu, ClinOps Consultant and Expert
Matt McKinney, Continuous Quality Solution Expert, Comprehend Systems
How One Clinical Operations Team Returned 100% of Studies to Within Risk Threshold: A Next Generation Monitoring Case Study May 26, 2016

LifeSciences - This webinar looks to highlight some of the major challenges of PV in early phase clinical trials and what can be done to overcome them
Speaker: Tom Nichols, Senior Director, Pharmacovigilance, Quanticate
The Challenges of Pharmacovigilance in Early Phase Clinical Trials

Apr 27, 2016

LifeSciences - This webinar will outline some of the 2015 Avoca Quality Consortium research around sponsor and CRO perceptions of quality in protocol design, effectiveness in identifying concerns from the patient perspective, and share some key factors identified that impede quality in protocols
Speakers: Jennifer Byrne, CEO, PMG Research, Inc.
JoAnn Muir, Head of Clinical QA Vendor Oversight, Novartis Pharmaceutical
Kenneth Getz, Director and Associate Professor, Tufts CSDD
Tomasz Sablinski, M.D., Ph.D., Founder, Transparency Life Sciences
Jeremy Gilbert, VP, Life Science Ventures, Patients Like Me
Moderator: Denise Calaprice-Whitty, Ph.D., Senior Consultant, The Avoca Group, Inc.
Protocol Quality: Challenges and Opportunities for Patient Centricity in Protocol Design and Execution Feb 11, 2016

LifeSciences - In order to generate reliable immune monitoring data that will help us determine the safety and efficacy of the therapeutic intervention approach from a global study, highly standardized methods to collect, process and prepare patient samples need to be implemented
Speaker: Sinnathamby Gomathinayagam, PhD, Senior Scientist, Translational Biomarkers Solutions, Covance
Recent Advances in Immune Monitoring Nov 5, 2015

LifeSciences - This presentation is designed to detail the similarities and differences between GMP controls for Rx and OTC products
Speaker: Eileen C. Nieto, CQA, Compliance Specialist, Compliance Insight, Inc.
Prescription and Over-the-Counter GMPs: Avoiding FDA Form 483 and Making the Best Decisions Oct 14, 2015

LifeSciences - Examples of signal detection through a multi-tiered approach will be provided, the roles of key players in the process will be introduced and the speaker will explore how the outcomes of signal detection and tending influence Benefit Risk assessments
Speaker: Robin Williams, B.S., CMC, Senior Safety Scientist, Drug Safety Alliance / Ashfield Pharmacovigilance
Insight into Detection & Management of Safety Signals Oct 9, 2015
LifeSciences - This webinar will discuss the rationale for including functional assessments in repeat-dose toxicology studies, how the data can be used for more impactful risk assessments, and the potential for more relevant clinical biomarker strategies
Speakers: Brian R. Berridge, DVM, PhD, DACVP, Director and Head of WW Animal Research Strategy in the Office of Animal Welfare, Ethics and Strategy, GlaxoSmithKline
Jonathan Heyen, M.S., D.A.B.T., Senior Principal Scientist - Safety Pharmacology Department, Pfizer La Jolla
Structural and Functional Endpoints in Repeat-Dose Toxicity Cardiovascular Risk Assessments and the Use of In Vivo Physiologic Monitoring May 20, 2015
The speakers will discuss strategies for maximizing the value vigilance of your established product
Speakers: Matthew McKeever, M.D., FAAP, VP and Global Head, Safety Knowledge and Reporting, Medical Safety, Aggregate Reporting, Benefit Risk Management and Regulatory Reporting, Quintiles
James C. Walker, CEO and Founder, Octagon Research Solutions, Inc.
Value Vigilance: A Transformative Approach to Managing Safety and Regulatory for Established Products Apr 2, 2015
This webinar will discuss new Biologics, Biosimilars, and Biobetters programs using case studies to illustrate strategy choices and the similarities and differences between each program
Speakers: Judith Newmark, PhD, Program Manager, Pharmacology/Toxicology/Ocular, Toxikon Corporation
Franck Grall, PharmD, PhD, Director, Cellular and Molecular Toxicology, Toxikon Corporation
Biologics, Biosimilars and Biobetters: Strategies for Nonclinical Safety Testing Mar 12, 2015
As biopharmaceutical companies increasingly seek to achieve global patient access, there is a need to develop PV procedures and systems that go beyond the strict confines of safety signal detection to provide for proactive benefit/risk management and optimized oversight
Speakers: Brian Guza , VP of Infosario Safety, Quintiles
Annette Williams , Senior Director, Pharmacovigilance Services, Lifecycle Safety , Quintiles
Patient-Centric Pharmacovigilance: Building Better Outcomes through Integrated Technology Oct 29/14
The process of signal detection (Signal Generation, Signal Strengthening, Signal Assessment and Signal Follow-Up) can generate more signals than true signals. Consequently, methods for ranking signals for further evaluation are required.
Speaker: Declan O’Rourke, MVB DipM MBA FRCVS, Ortec Consultancy, UK
Signal Detection & Trending in Veterinary Pharmacovigilance Sep 15/14
Now that both regulators and the industry alike have had almost two years of experience evolving the expectations of how PBRERs should be written and assessed, biopharmaceutical companies must create streamlined processes that will allow them to develop consistent standards for meaningful benefit-risk assessments
Speakers: Dominique Coleman, Director, Safety Aggregate Reporting and Analytics (SARA), Quintiles
Carrie Messina, Safety Aggregate Reporting Manager for the SARA group, Quintiles
Top Five Best Practices for Developing Your Periodic Benefit Risk Evaluation Report (PBRER) Sep 11/14
This presentation will address regulatory trends and how to design a phase-appropriate E&L program
Speaker: Wayland Rushing, Ph.D., Senior Scientific Advisor, ABC Laboratories
Are Extractable and Leachables Going Phase-Appropriate? Sep 4/14
This webinar will focus on translating current business drivers and challenges within the global drug product labeling domain into a set of opportunities and next-generation operating models that support scale, efficiency, quality and compliance
Speakers: Bindu Narang, Director of Scientific Writing and Regulatory Affairs, Sciformix
Boris Jankowski, Director of Solutions Architecture, Sciformix
Craig Trautman, CEO, Intagras
Trends & Best Practices in Global Drug Product Labeling Management: Taking Control of the End-to-End Labeling Process June 24/14
This webinar focuses on tips and best practices for navigating through the complex regulatory landscape of cosmetic adverse event reporting
Speaker: Sharon Donatucci, Vice President of Pharmacovigilance Operations, Drug Safety Alliance, Inc.
Cosmetovigilance – Vignette for the First Regulatory Year of EU Regulations – Impact on North America and Europe Jun 5/14
Life Sciences - This 3-part series examines the global pharmacovigilance and drug safety landscape and outlook for future years
Speaker: Marie-Ange Noue, Local Medical Information Officer & Deputy Local Drug Safety Officer, EMD Serono
Pharmacovigilance Global Landscape, 2014
Part 3: Medical Information Then and Now: Leveraging Technology to Enhance Customer Experience
May 29/14
Life Sciences - This 3-part series examines the global pharmacovigilance and drug safety landscape and outlook for future years
Speaker: Fernando Pereira, Pharmacovigilance Manager, Merck Sharp & Dohme
Pharmacovigilance Global Landscape, 2014
Part 2: Pharmacovigilance and Best Practices in Latin America: An Overview on Safety Reporting, ADR Management & Scope of ANVISA
May 21/14
This webinar focuses on the importance of consistent quality practices for management of veterinary pharmacovigilance, particularly, adverse event data
Speaker: Renee Helms, DVM, Director, PV Operations, Drug Safety Alliance, Inc.
Minimizing Negative Impact of Dirty Data in Veterinary Pharmacovigilance May 15/14
Life Sciences - This 3-part series examines the global pharmacovigilance and drug safety landscape and outlook for future years
Speaker: Marcin Marciniak, Director Drug Safety & Pharmacovigilance / Deputy EU QPPV, PregLem SA
Pharmacovigilance Global Landscape, 2014
Part 1: ADR Management and Reporting to EudraVigilance
May 14/14
This presentation reviews some of the elements that go into decision making for outsourcing pharmacovigilance work especially for off shore projects
Speaker: Angela Pitwood, Vice President, IPM Safety Services
Cracking the Code…
To Successfully Outsourcing Pharmacovigilance Activites
Apr 30/14
This webinar will focus on APAC, including a review of the new GVP guideline by EMA & its impact, the challenges of complying with changing country regulations for patient data collection, and an overview of the major achievements of PvPI
Speaker: Michal Borawski, International Pharmacovigilance Officer for the Asia-Pacific Region Affairs, Sanofi Pasteur
Pharmacovigilance in APAC: An Update and Focus on India (PvPI)

Mar 13/14

This webinar will outline the methodology and conduct of safety benefit-risk assessments for post-marketed products
Speaker: Mary Mease, RPH, MPH, Senior Director, Risk Management, Quintiles
Pharmacovigilance Benefit-Risk Assessments: Requirements, Transparency, and Implications Dec 6/13
A discussion of current trends and insights by the presenters
Speakers: Dr. Marcin Marciniak, Director Drug Safety & Pharmacovigilance, PregLem SA, and member of Gedeon Richter Group
Dr. Philip Jones, BMBS, MA, MSc, PhD, Associate Director & Deputy QPPV, Symogen Limited

Pharmacovigilance: ADR Management and Reporting & Outsourcing Trends

Dec 4/13

This presentation reviews the background and drivers for making the decision - when to outsource pharmacovigilance work. There are several schools of thought on how best to handle safety data as well
Speaker: Angela Pitwood, Vice President, IPM Safety Services, a division of IndiPharm, Inc.
Outsourcing in Pharmacovigilance Nov 5/13
The webinar will examine the objectives of PMOS and Phase IV studies, possible designs, benefits, disadvantages and challenges
Speaker: John S. Sampalis, B.Sc., B.A. (Hon.), M.Sc., Ph.D., F.A.C.E., Founder, CEO and Chief Scientific Officer, JSS Medical Research Inc.
Post-Marketing Observation Studies (PMOS) and Phase IV Studies Jun 5/13
Join our speaker from Bristol-Myers Squibb, one of the first companies to understand the multiple benefits of item level serialization, as he examines serialization and its use in fighting counterfeit drugs
Speaker: Daljeet Sahni, AD EDO Engineering, Global Supply Chain, Bristol-Myers Squibb

Serialization in Pharmaceuticals

Feb 27/13

This webinar will focus on ensuring compliance with international and local country specific PV Requirements from an Asia-Pacific perspective
Speaker: Michal Borawski, International Pharmacovigilance Officer for the Asia-Pacific Region Affairs, Sanofi Pasteur

How to Ensure Pharmacovigilance Practices are Compliant with Global Safety Requirements: Challenges in Asia-Pacific

Jan 30/13

LifeSciences The webinar will examine operational and analytical considerations for early detection of potential organ toxicity
Speakers from ACM Global Central Laboratory:
Mark Engelhart, Chief Commercial Officer
Andrew Botham, PhD, Research & Development Manager
Maria-Magdalena Patru, MD, PhD, Scientific Affairs Medical Liaison
Drug-Induced Organ Toxicity (DIOT): The Early Detection and Management of Elevated Biomarkers to Ensure Patient Safety Oct 17/12
LifeSciences This webinar will examine the new EU legislation and its impact on the pharmacovigilance practice of regulators and the pharmaceutical industry in years 2012-2016
Speaker: Jan Petracek, MD, MSc, DIC, Partner, CEO, PharmInvent
EU Pharmacovigilance Change Readiness 2012 Apr 4/12
LifeSciences The purpose of this presentation is to discuss how DART capabilities have been introduced into an established toxicology laboratory at Southern Research, in compliance with Good Laboratory Practices (GLP)
Speakers: Stephen B. Harris, Ph.D., Fellow, ATS, President, Stephen B. Harris Group
Eve Mylchreest, Ph.D., Program Leader, Developmental and Reproductive Toxicology (DART), Southern Research
Kellye K. Daniels, Ph.D., D.A.B.T., Director, Toxicology and Pathology Services Department, Southern Research
Successful Introduction of GLP-compliant Reproductive Toxicology Programs Feb 28/12
LifeSciences This webinar will discuss the new US REMS guidance and EU-RMP legislation, and what companies need to do in order to prepare for submissions
Speakers: Dr. William Maier, Vice-President, Epidemiology, Drug Safety and Risk Management, Registrat-Mapi
Dr. Carl de Moor, Vice President Epidemiology, North America, Registrat-Mapi
Dr. Paula Thompson, Senior Epidemiologist, Registrat-Mapi
Risk Management of Drug Safety: Pre-Approval Planning and Research will Ensure Success Sep 23/11
LifeSciences The webinar will focus on improving preclinical studies by combining MDS Pharma Services' 40 years of experience and insight in safety pharmacology and toxicology, with innovative technology and processes that improve study data and provide greater animal welfare. Presentations will highlight key challenges, best practices and methodologies.
Speakers: Dr. Stéphane Milano, Vice President, Drug Safety Assessment, MDS Pharma Services
Paul Barrow, Director of Toxicology, MDS Pharma Services
Sarah Merrett, Lean Sigma Black Belt, MDS Pharma Services
Advances Insight and Innovation: Novel Approaches to Safety Pharmacology and Toxicology in the 21st Century June 23/09
LifeSciences Anti- Counterfeiting Drug Strategies
Speakers: Mr. Eshetu Wondemagegnehu Technical Officer & Focal Person for Counterfeit Drugs, Quality Assurance & Safety Medicines Essential Drugs and Medicines Policy World Health Organization
Dr. Peter Rost, VP, Marketing, Endocrine Care, Pfizer. (Dr. Rost speaks as a private citizen and does not represent Pfizer in his talk.)
Anti-Counterfeiting Drug Strategies Dec 10/04

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