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 indicates items that take place in your region |
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 Annual Meeting | |
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 eLearning | |
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Clinical Investigator: Module 1 - Study Preparation and Initiation - (Mar 21, 2010) - Online
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Clinical Investigator: Module 2 - Conducting The Study - (Mar 21, 2010) - Online
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Crisis Management - (Mar 21, 2010) - Online
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Database Management - (Mar 21, 2010) - Online
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Literature Evaluation - (Mar 21, 2010) - Online
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Literature Searching - (Mar 21, 2010) - Online
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Medical Inquires - (Mar 21, 2010) - Online
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Medical Writing - (Mar 21, 2010) - Online
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Product Labeling - (Mar 21, 2010) - Online
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Regulatory Issues - (Mar 21, 2010) - Online
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Informed Consent - (Mar 21, 2010) - Online
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Statistics for Medical Communications Professionals - (Mar 21, 2010) - Online
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 EudraVigilance | |
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Eudravigilance - Electronic Reporting of ICSRs in the EEA - (Mar 29, 2010) - Lisboa
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Eudravigilance - Electronic Reporting of ICSRs in the EEA - (Apr 12, 2010) - London
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EudraVigilance & Electronic Reporting of ICSRs in the EEA - (Apr 19, 2010) - Horsham
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Eudravigilance - Electronic Reporting of ICSRs in the EEA - (Apr 26, 2010) - London
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Eudravigilance - Electronic Reporting of ICSRs in the EEA - (May 03, 2010) - Madrid
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Eudravigilance - Electronic Reporting of ICSRs in the EEA - (May 17, 2010) - London
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EudraVigilance: Medicinal Product Dictionary - (May 25, 2010) - London
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Eudravigilance - Electronic Reporting of ICSRs in the EEA - (May 26, 2010) - London
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Eudravigilance - Electronic Reporting of ICSRs in the EEA - (Jun 09, 2010) - London
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Eudravigilance - Electronic Reporting of ICSRs in the EEA - (Jun 14, 2010) - London
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EudraVigilance Information Day - (Jun 22, 2010) - London
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Eudravigilance - Electronic Reporting of ICSRs in the EEA - (Jun 28, 2010) - San Marino
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Eudravigilance - Electronic Reporting of ICSRs in the EEA - (Jul 05, 2010) - London
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Eudravigilance - Electronic Reporting of ICSRs in the EEA - (Sep 01, 2010) - London
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EudraVigilance: Medicinal Product Dictionary - (Sep 14, 2010) - London
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Eudravigilance - Electronic Reporting of ICSRs in the EEA - (Sep 15, 2010) - London
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EudraVigilance: Electronic Reporting of ICSRs in the EEA - (Sep 20, 2010) - Paris
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EudraVigilance - Electronic Reporting of ICSRs in the EEA - (Sep 29, 2010) - Vienna
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Eudravigilance - Electronic Reporting of ICSRs in the EEA - (Oct 13, 2010) - London
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EudraVigilance Information Day - (Oct 19, 2010) - London
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Eudravigilance - Electronic Reporting of ICSRs in the EEA - (Oct 20, 2010) - London
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EudraVigilance & Electronic Reporting of ICSRs in the EEA - (Oct 25, 2010) - Horsham
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EudraVigilance: Medicinal Product Dictionary - (Nov 09, 2010) - London
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Eudravigilance - Electronic Reporting of ICSRs in the EEA - (Nov 10, 2010) - London
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Eudravigilance - Electronic Reporting of ICSRs in the EEA - (Nov 17, 2010) - London
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Eudravigilance - Electronic Reporting of ICSRs in the EEA - (Dec 15, 2010) - London
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 In-Company Training | |
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 Meeting | |
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CTD Dossier Requirements Focus on EU Module 1 and Quality Module 3 - (Mar 21, 2010) - Mumbia
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DIA/FDA CDER/CBER Computational Science Annual Meeting - (Mar 22, 2010) - North Bethesda
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3rd Oligonucleotides-based Therapeutics Conference - (Mar 23, 2010) - Bethesda
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Evidence-based Medicine & Health Technology Assessment: Moving From Separate Appraisals to Synergistic Communications - (Mar 23, 2010) - WASHINGTON
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CTD Dossier Requirements: Focus on EU Module 1 and Quality Module 3 - (Mar 24, 2010) - Hyderabad
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FDA Guidance on Adaptive Design for Clinical Trials - (Mar 26, 2010) - Silver Spring
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Cardiovascular Safety in Drug Development: QT, Arrhythmias, Thrombosis, and Bleeding - (Apr 11, 2010) - Arlington
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Clinical Development of Stem Cell Therapies: Scientific, Regulatory and Ethical Considerations - (Apr 12, 2010) - North Bethesda
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The 4th Annual Conference in Japan for Asian New Drug Development - (Apr 13, 2010) - Tokyo
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4th Annual FDA/DIA Statistics Forum - (Apr 18, 2010) - North Bethesda
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4th European Forum for Qualified Person for Pharmacovigilance (QPPV) - (Apr 21, 2010) - London
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DIA and FDA Office of Women’s Health (OWH): Strategies for Ensuring Representation of Patient Demographics in Clinical Research for Regulatory Review - (May 05, 2010)
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3rd Annual Regulatory Conference on “Global Regulatory Challenges: Quest for Optimization - (May 07, 2010) - Andheri East
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2nd DIA China Annual Meeting - (May 16, 2010)
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The 1st DIA Cardiac Safety Workshop in Japan - (May 25, 2010) - Tokyo
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DIA European Regulatory Affairs Forum 2010 - (Jun 01, 2010) - London
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Workshop on Statistical Methodology in Clinical R&D - (Sep 27, 2010) - Vienna
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4th Annual Clinical Forum 2010 - (Oct 11, 2010) - Lisboa
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Making the Right Investments in Biomedical Informatics for Drug Development and Healthcare - (Oct 13, 2010)
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4th European Cardiac Safety Conference - (Oct 25, 2010)
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7th DIA Japan Annual Meeting - (Oct 28, 2010) - Tokyo
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DIA’s 8th Annual Canadian Meeting: “Keeping Canada on the Map: Fostering Innovation and Access to Drugs in Canada” - (Nov 03, 2010)
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2nd Joint DIA/ European Medicines Agency Innovation Forum: Is the EU Regulatory Framework Ready? - (Nov 29, 2010) - London
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11th Conference on European Electronic Document Management - (Dec 01, 2010) - Nice
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 Training Course | |
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Utilizing Chemistry, Manufacturing & Control (CMC) in Drug Development - (Apr 08, 2010) - Horsham
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Overview of Drug Development - (Apr 12, 2010) - Horsham
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Development of a Clinical Study Report - (Apr 16, 2010) - Horsham
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Essentials of Project Management - (Apr 19, 2010) - Horsham
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Introduction to Portfolio Management and Performance Metrics - (Apr 20, 2010) - Horsham
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Project Information, Communication, and Knowledge Management - (Apr 22, 2010) - Horsham
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High Performance Biopharm Teams - (Apr 22, 2010) - Horsham
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An Introduction to Product Information Management (PIM) - (Apr 26, 2010) - Vienna
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CTD Dossier Requirements: Focus on EU Module 1 and Quality Module 3 - (Apr 26, 2010) - Vienna
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Good Management of Medical Devices - (Apr 26, 2010) - Paris
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Introduction to Signal Detection and Data Mining in Pharmacovigilance in Europe - (Apr 26, 2010) - Paris
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How to Prepare for Pharmacovigilance - Audits and Inspections in Europe - (Apr 27, 2010) - Paris
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New Drug Product Development & Lifecycle Management - (Apr 29, 2010) - Horsham
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Drug Safety Surveillance and Epidemiology - (May 03, 2010) - Horsham
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Essentials of Clinical Study Management - (May 05, 2010) - Vienna
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Introduction to Signal Detection and Data Mining - (May 05, 2010) - Horsham
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How to Prepare for a Safety Inspection - (May 06, 2010) - Horsham
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Risk Management and Communication to Optimize Medicinal Product Safety - (May 06, 2010) - Horsham
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Practical Guide for Pharmacovigilance: Clinical Trials and Post Marketing - (Jun 02, 2010) - Prague
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Crisis Management - (Jun 03, 2010) - Basel
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European Regulatory Affairs - (Jun 03, 2010) - Prague
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Advanced GCP Study Monitoring - (Jun 04, 2010) - Prague
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European Medicines Agency Information Day: The New Individual Case Safety Report (ICSR) International Standard and ICH E2B/M2 - (Jun 25, 2010) - London
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Leadership Experience - (Aug 09, 2010) - Boston
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Regulatory Affairs Part I: The IND Phase and Part II: The NDA Phase - (Aug 09, 2010) - Boston
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European Regulatory Affairs - (Aug 09, 2010) - Horsham
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Clinical Statistics for Nonstatisticians - (Sep 13, 2010) - Paris
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Medical Approach in Diagnosis and Management of ADRs - (Sep 13, 2010) - Boulogne-Billancourt (Paris)
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Regulatory Affairs Part I: The IND Phase - (Sep 13, 2010) - Horsham
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Drug Safety Surveillance and Epidemiology - (Sep 20, 2010) - Horsham
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Clinical Project Management in Europe - Part I - (Sep 22, 2010) - Basel
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Building the eCTD: Practical Solutions to Compile Electronic Submissions - (Sep 23, 2010) - Basel
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Clinical Statistics for Nonstatisticians - (Sep 27, 2010) - Horsham
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Advanced Clinical Statistics for Non-Statisticians - (Sep 29, 2010) - Horsham
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Regulatory Affairs Part II: The NDA Phase - (Oct 04, 2010) - Horsham
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Practical GCP Compliance Auditing of Trials & Systems - (Oct 06, 2010) - London
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Utilizing Chemistry, Manufacturing & Control (CMC) in Drug Development - (Oct 07, 2010) - Horsham
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Introduction to Signal Detection and Data Mining in Pharmacovigilance - (Oct 07, 2010) - London
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Crisis Management - (Oct 14, 2010) - Boulogne-Billancourt (Paris)
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How to Prepare for a Safety Inspection - (Oct 15, 2010) - Horsham
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US Regulatory Affairs - (Oct 18, 2010) - Prague
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Leadership Experience - (Oct 18, 2010) - San Diego
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Essentials of Project Management - (Oct 18, 2010) - Horsham
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New Drug Product Development & Lifecycle Management - (Oct 19, 2010) - Horsham
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Executing and Controlling Projects - (Oct 21, 2010) - Horsham
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Enterprise Resource Planning - (Oct 21, 2010) - Horsham
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Excellence in Pharmacovigilance: Clinical Trials and Post Marketing - (Oct 25, 2010) - Vienna
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Good Management of Medical Devices - (Oct 27, 2010) - Geneva
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An Introduction to Product Information Management (PIM) - (Oct 28, 2010) - Geneva
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Pre-marketing Clinical Safety & Pharmacovigilance - (Nov 01, 2010) - Horsham
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Introduction to Signal Detection and Data Mining - (Nov 03, 2010) - Horsham
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Post-marketing Drug Safety & Pharmacovigilance - (Nov 04, 2010) - Horsham
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Introduction to Good Clinical Practices and Auditing - (Nov 08, 2010) - Horsham
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Regulatory Affairs in Biologics - (Nov 11, 2010) - Horsham
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Regulatory Affairs Part I: The IND Phase and Part II: The NDA Phase - (Nov 15, 2010) - Baltimore
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Clinical Project Management - (Nov 15, 2010) - Horsham
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Project Risk Management - (Nov 18, 2010) - Horsham
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European Regulatory Affairs - (Nov 18, 2010) - Boulogne-Billancourt (Paris)
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Advanced GCP Study Monitoring - (Nov 19, 2010) - Boulogne-Billancourt (Paris)
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Non-Clinical Safety Sciences and Their Regulatory Aspects - (Nov 22, 2010) - Lisbon
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Practical Guide for Pharmacovigilance: Clinical Trials and Post Marketing - (Dec 01, 2010) - Paris
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CTD Dossier Requirements: Focus on EU Module 1 and Quality Module 3 - (Dec 05, 2010)
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Overview of Drug Development - (Dec 08, 2010) - Horsham
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 Webinar | |
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WEBINAR: eCTD 101: An Overview and its Impact on the Regulatory Submissions Process - (Mar 30, 2010) - Online
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WEBINAR: Case Processing and Signal Detection: Business Process Optimization in Pharmacovigilance - (Mar 31, 2010) - Online
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WEBINAR: FDAAA and REMS: Two Years and Counting - (Apr 08, 2010) - Online
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WEBINAR: Safety Reporting Requirement in Clinical Trials: Indian and European Perspective - (Apr 20, 2010) - Online
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WEBINAR: Update on AMCP Format Version 3.0: Industry Perspective - (Apr 22, 2010) - Online
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WEBINAR: CDER Town Meeting: Current Hot Topics Regarding eSubmissions - (Apr 29, 2010) - Online
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Basics of an IND - 6 Part Online Training Series - (May 03, 2010) - Online
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Overview of Drug Development from Discovery through Marketing Application - 3-Part Online Training Series - (May 11, 2010) - Online
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Basics of the NDA - Six-Part Online Training Series - (May 17, 2010) - Online
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WEBINAR: FDA Discusses Signaling Using Data Mining Results - (May 20, 2010) - Online
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Basics of Interactions with FDA during the IND/NDA Phases - Two-Part Online Series - (Jun 02, 2010) - Online
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Regulatory Aspects of Prescription Drug/Biologics Advertising and Promotional Labeling Online Training Course - (Jun 04, 2010) - Online
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Clinical Statistics for Nonstatisticians - 5-Part Online Training Series - (Jul 12, 2010) - Online
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Computer Systems Validation for the Non-computer Professional Online Training Series - (Jul 19, 2010) - Online
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Introduction to Signal Detection and Data Mining - 4 Part Online Training Series - (Jul 21, 2010) - Online
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Fundamentals of Project Management for the Non-project Manager - 4-Part Online Training Series - (Aug 09, 2010) - Online
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Development of a Clinical Study Report - 3-Part Online Training Series - (Sep 16, 2010) - Online
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Good Clinical Practices for the Clinical Research Professional - 4 Part Online Training Series - (Oct 12, 2010) - Online
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An Art of Writing a Clinical Overview - 3-part Online Training Series - (Oct 19, 2010) - Online
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Contributing to High-performance Biopharm Teams - 6 Part Online Training Series - (Oct 28, 2010) - Online
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Who's Monitoring the Monitor - 3-Part Online training Series - (Nov 05, 2010) - Online
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 Webinar Archive | |
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ARCHIVED WEBINAR: New REMS Draft Guidance Issued by FDA - (Mar 21, 2010) - Online
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ARCHIVED WEBINAR: Safety and Ethical Emerging Issues Impacting Patient Recruitment and Retention - (Mar 21, 2010) - Online
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ARCHIVED WEBINAR: Innovative Medicines Initiative - Better Tools for Better Medicines - (Mar 21, 2010) - Online
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ARCHIVED WEBINAR: Global Perspective on What Sites Need from Sponsors and CRO's - (Mar 21, 2010) - Online
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ARCHIVED WEBINAR: Post Approval Changes (Variations) in the European Union Focusing on CMC - (Mar 21, 2010) - Online
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ARCHIVED WEBINAR: Statistical Methods for Interval Censored Data - (Mar 21, 2010) - Online
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ARCHIVED WEBINAR: C-Path’s Predictive Safety Testing Consortium Status: Updates on Novel Kidney, Liver, and Skeletal Muscle Safety Biomarkers - (Mar 21, 2010) - Online
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ARCHIVED - Core Safety Profile and Labeling Harmonization in the European Union - (Mar 21, 2010) - Online
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ARCHIVED - Clinical Trial Landscape in India Webinar Series – Part 3 -Ethical Issues in Clinical Trials in Individuals with Reduced Autonomy - (Mar 21, 2010) - Online
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ARCHIVED - Key Components of the EU Risk Management Plan (RMP) and US Risk Evaluation and Mitigation Strategy (REMS) - (Mar 21, 2010) - Online
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ARCHIVED - Medical Communications: A Focus on Quality and Compliance - (Mar 21, 2010) - Online
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ARCHIVED - Pharmacovigilance for Generics: Challenges and Strategies - (Mar 21, 2010) - Online
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ARCHIVED - How to Ensure Legally Admissible and Compliant Digital Signatures and Identities - (Mar 21, 2010) - Online
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ARCHIVED - Why You Need to Know About the EDM Reference Model - (Mar 21, 2010) - Online
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ARCHIVED - Communication Fundamentals for Clinical Trial Success: Mastering the DM Language - (Mar 21, 2010) - Online
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ARCHIVED - Generic Biologics: Separating Science Fact from Science Fiction - (Mar 21, 2010) - Online
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ARCHIVED: The New Look at eCTD Lifecycle Management: How Mapping from NDA to IND can Streamline Submission Lifecycle Chores - (Mar 21, 2010) - Online
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ARCHIVED - Wyeth v. Levine: Understanding the U.S. Supreme Court's Recent Failure-to-Warn Preemption Case - (Mar 21, 2010) - Online
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ARCHIVED - FDA Discusses Sentinel Initiative - (Mar 21, 2010) - Online
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Archived - Electronic Submission Gateway Update - (Mar 21, 2010) - Online
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ARCHIVED - Overview of Meta-Analysis Including Analysis of Rare Adverse Event Data - META-ANALYSIS WEBINAR SERIES (Part 1) - (Mar 21, 2010) - Online
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ARCHIVED - Part 2 -META-Analysis of Observational Data - META-ANALYSIS WEBINAR SERIES (Part 2) - (Mar 21, 2010) - Online
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ARCHIVED - Part 3 - Role of Meta-Analysis in Regulatory Decision Making - META-ANALYSIS WEBINAR SERIES (Part 3) - (Mar 21, 2010) - Online
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ARCHIVED - Use of Foreign Trial Data for NDA Approval - (Mar 21, 2010) - Online
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ARCHIVED - How Strategic Partnerships Can Accelerate Pandemic Flu Vaccine Development - (Mar 21, 2010) - Online
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ARCHIVED - Regulated Product Submissions (RPS) Promise and Progress - (Mar 21, 2010) - Online
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ARCHIVED - European Guidance on Risk Management of Human Pharmaceuticals in Pregnancy and Lactation - (Mar 21, 2010) - Online
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Novel Approaches for Using Electronic Health Records for Pharmacovigilance - (Mar 21, 2010) - Online
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Archived - Pharmacovigilance Regulations in India - (Mar 21, 2010) - Online
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Archived - Regulatory Strategies for Ensuring Compliance in Global Clinical Trials - (Mar 21, 2010) - Online
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Archived - Update on FDA's Good Importer Practices and Pharnaceutical Secure Supply-chain Pilot Program - (Mar 21, 2010) - Online
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ARCHIVED - FDA and Industry Perspectives on Signal Detection and Data Mining - (Mar 21, 2010) - Online
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Archived - Proven Strategies for Global Recruitment - (Mar 21, 2010) - Online
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ARCHIVE - Cost-Effective Adverse Event Case Processing - (Mar 21, 2010) - Online
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ARCHIVED - Electronic Data Capture: Strategies to Enhance Data Capture, Site Satisfaction and Study Participation - (Mar 21, 2010) - Online
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Archived - The Evolving role of Project and Alliance Managers at Each Stage of Product Development - (Mar 21, 2010) - Online
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Archived - Defining and Managing Protocol Deviation/Violation/Exception - (Mar 21, 2010) - Online
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ARCHIVED - Regulatory Requirements for Conducting Clinical Trials in India - (Mar 21, 2010) - Online
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ARCHIVED - Recruitment Budget Planning - (Mar 21, 2010) - Online
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ARCHIVED - Risk Management Strategies and Pharmacovigilance of Opioids and Other Controlled Substances - (Mar 21, 2010) - Online
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ARCHIVED WEBINAR: Using eClinical Tools to Improve Data Quality - (Mar 21, 2010) - Online
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ARCHIVED: FDA eDRL Process - (Mar 21, 2010) - Online
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ARCHIVED: A New Approach to Large Observational Studies: “Local Control” Approach to Analysis - (Mar 21, 2010) - Online
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ARCHIVED: Critical Path Webinar Series- Part 1 - Standards for Emerging Biomarkers - (Mar 21, 2010) - Online
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ARCHIVED - Choosing the Appropriate Electronic Data Capture Hosting Model - (Mar 21, 2010) - Online
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ARCHIVED - Cardiac Safety Issues in Early Drug Development - (Mar 21, 2010) - Online
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ARCHIVED - Clinical Trial Landscape in India Webinar Series – Part 1 -Worldwide Regulatory Landscape: Current Regulatory Initiatives in the US, Canada and EU - (Mar 21, 2010) - Online
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ARCHIVED - Pre-marketing Strategies for Central Nervous System (CNS) Drugs - (Mar 21, 2010) - Online
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ARCHIVED - Registries and Safety - (Mar 21, 2010) - Online
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ARCHIVED WEBINAR: Patient-reported Outcome Measures: Announcing the Final FDA PRO Guidance - (Mar 21, 2010) - Online
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ARCHIVED WEBINAR: Pharmacovigilance Guidance in Relation to Social Web-Based Media - (Mar 21, 2010) - Online
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ARCHIVED WEBINAR: Pharmacovigilance from the Medical Writer Perspective - (Mar 21, 2010) - Online
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ARCHIVED WEBINAR: Update on the Revised European Labeling Guideline – European Summary of Product Characteristics - (Mar 21, 2010) - Online
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ARCHIVED WEBIAR: Progression-Free Survival Oncology Webinar 4-Part Series – Part 3: Handling Missing/Censored Observations and Statistical Evaluation of PFS (Analysis of PFS) - (Mar 21, 2010) - Online
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ARCHIVED WEBINAR: Do Subvisible Particles Contribute to the Immunogenicity of Therapeutic Proteins? - (Mar 21, 2010) - Online
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ARCHIVED WEBINAR: Regulatory Strategies in Latin America: New Conquest for Pharmaceutical Companies for Timely Submissions and Project Start-Ups - (Mar 21, 2010) - Online
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ARCHIVED WEBINAR: Opioid Class REMS: What’s It All About? - (Mar 21, 2010) - Online
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ARCHIVED WEBINAR: Expanding Clinical Research Beyond Borders: The Importance of Latin America - (Mar 21, 2010) - Online
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ARCHIVED WEBINAR: FDA Strategic Plan for Risk Communication - (Mar 21, 2010) - Online
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ARCHIVED WEBINAR: Progression-Free Survival Oncology Webinar 4-Part Series - Part 1: Clinical Assessment and Radiological Evaluation of Progression-Free Survival (PFS) - (Mar 21, 2010) - Online
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ARCHIVED WEBINAR: Progression-Free Survival Oncology Webinar 4-Part Series – Part 2: Criteria for Determination of Progression and Statistical Evaluation of PFS: Role and Design of Independent Review - (Mar 21, 2010) - Online
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ARCHIVED WEBINAR: CMC Issues and 505(b)(2) Submissions - (Mar 21, 2010) - Online
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ARCHIVED WEBINAR: Ethical Considerations for Conducting Clinical Trials in the Emerging Markets - (Mar 21, 2010) - Online
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ARCHIVED WEBINAR: Progression-Free Survival Oncology Webinar 4-Part Series - Part 4: Regulatory Considerations: Lessons Learned and Path Forward - (Mar 21, 2010) - Online
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ARCHIVED WEBINAR: Conducting Clinical Trials in India-Current Update on Opportunities and Challenges - (Mar 21, 2010) - Online
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