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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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Computerized Systems Inspections in the Pharmaceutical Industry - (Jul 31, 2010) - Online
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A Tour of FDA - (Jul 31, 2010) - Online
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Good Laboratory Practices (GLPs) - (Jul 31, 2010) - Online
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GxPs - (Jul 31, 2010) - Online
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HIPAA - The Impact on Clinical Research - (Jul 31, 2010) - Online
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Introduction to GMPs - (Jul 31, 2010) - Online
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Investigational Product Development - (Jul 31, 2010) - Online
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ISO 14155: Obligations of Sponsors and Monitors for Medical Device Trials - (Jul 31, 2010) - Online
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Key Concepts of Process Validation - (Jul 31, 2010) - Online
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Laboratory Specimens for Clinical Research - (Jul 31, 2010) - Online
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Medical Device Safety Reporting - (Jul 31, 2010) - Online
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Orientation to GMP Compliance - (Jul 31, 2010) - Online
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Overview of the Clinical Research Process - (Jul 31, 2010) - Online
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Part 11: Electronic Records and Signatures - Application - (Jul 31, 2010) - Online
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Part 11: Electronic Records: Electronic Signatures - (Jul 31, 2010) - Online
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Principles of Good Documentation - (Jul 31, 2010) - Online
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Protection of Human Subjects in Clinical Trials - (Jul 31, 2010) - Online
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Selecting and Managing Clinical Contract Research Organizations (CROs) - Pulled from Roles Based Library - (Jul 31, 2010) - Online
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Understanding Post-Approval Changes - (Jul 31, 2010) - Online
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A Tour of Health Canada - (Jul 31, 2010) - Online
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A Tour of Health Europe - (Jul 31, 2010) - Online
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Aspects of Regulatory History - (Jul 31, 2010) - Online
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Bioresearch Monitoring Program (BIMO): Introduction - (Jul 31, 2010) - Online
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The Clinical Development Process: Investigational Product, Plan, and Data Management - (Jul 31, 2010) - Online
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Drug Safety & Adverse Event Reporting - (Jul 31, 2010) - Online
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Ethical Review Boards - (Jul 31, 2010) - Online
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Ethics as the Foundation to Clinical Research - (Jul 31, 2010) - Online
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Awareness of FDA Inspections for Pharmaceutical Manufacturers - (Jul 31, 2010) - Online
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Biotechnology: An Overview of Compliance Considerations - (Jul 31, 2010) - Online
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Change Control - (Jul 31, 2010) - Online
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Clinical Trial Audits and Consequences of Non-Compliance - (Jul 31, 2010) - Online
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Computerized Systems Inspections in the Medical Device Industry - (Jul 31, 2010) - Online
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European Union Clinical Trials Directive - (Jul 31, 2010) - Online
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GMP Principals of SOPs - (Jul 31, 2010) - Online
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GMP Updates - Enforcement Changes at the New FDA - (Jul 31, 2010) - Online
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GMPs for API Bulk Manufacturers - (Jul 31, 2010) - Online
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Good Clinical Practices (GCPs) for New Product Investigations - (Jul 31, 2010) - Online
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Crisis Management - (Jul 31, 2010) - Online
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Database Management - (Jul 31, 2010) - Online
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Literature Evaluation - (Jul 31, 2010) - Online
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Literature Searching - (Jul 31, 2010) - Online
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Medical Inquires - (Jul 31, 2010) - Online
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Medical Writing - (Jul 31, 2010) - Online
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Product Labeling - (Jul 31, 2010) - Online
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Regulatory Issues - (Jul 31, 2010) - Online
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Clinical Investigator: Module 1 - Study Preparation and Initiation - (Jul 31, 2010) - Online
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Clinical Investigator: Module 2 - Conducting The Study - (Jul 31, 2010) - Online
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Informed Consent - (Jul 31, 2010) - Online
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Statistics for Medical Communications Professionals - (Jul 31, 2010) - Online
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Euro Meeting
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EudraVigilance
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EudraVigilance & Electronic Reporting of ICSRs in the EEA - (Aug 09, 2010) - Horsham
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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 - Electronic Reporting of ICSRs in the EEA - (Nov 03, 2010) - Lisboa
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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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Pharmaceutical Quality Forum: CMC Compliance - (Aug 07, 2010) - Gujarat
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Quality of Active Pharmaceutical Ingredients - (Sep 17, 2010) - Mumbai
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1st Joint DIA/EMA Workshop on Statistical Methodology in Clinical R&D - (Sep 27, 2010) - Vienna
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Joint EFGCP Children's Medicine Working Party 6th Annual Conference and DIA 4th Paediatric Forum - (Sep 28, 2010) -
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Global Approach to the Risk Management of Medicines - (Sep 30, 2010) - Washington
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Joint DIA/EFGCP Pharmacovigilance Audit and Inspection - Opportunities for Patient Safety - (Oct 01, 2010) - London
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Development of Type 2 Diabetes Mellitus Drugs: State of the Art Cardiovascular Safety Assessments - (Oct 05, 2010) - Washington
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4th Annual Clinical Forum 2010 - (Oct 11, 2010) - Lisboa
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Advancing Pediatric Research in the US - (Oct 12, 2010) - Bethesda
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Early Drug Development: Navigating the Treacherous Rapids - (Oct 13, 2010) - Bethesda
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Investing in Biomedical Informatics for Drug Development and Health Care - (Oct 13, 2010) - National Harbor
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Maternal and Pediatric Drug Safety Symposium - (Oct 13, 2010) - Bethesda
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Partnerships to Advance Patient Recruitment and Retention in Clinical Research - (Oct 14, 2010) - Rockville
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Joint DIA-ACT Study Director Workshop - (Oct 18, 2010) -
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5th Annual Conference on Drug Discovery and Clinical Development Meeting the Challenges of Next Generation R&D: Enhancing Efficiency, Effectiveness and Innovation - (Oct 23, 2010) - Bangalore
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4th European Cardiac Safety Conference - (Oct 25, 2010) - Nice
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Ensuring Quality and Balancing Risks for Multiregional Clinical Trials: Statistical, Clinical, Regulatory, and Ethical Factors - (Oct 26, 2010) - Bethesda
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Tomorrow's Project Manager: Evolving Competencies for Biopharmaceutical Professionals - (Oct 26, 2010) - Bethesda
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The 9th Annual Electronic Submissions Conference: Working Together Towards a Global Strategy - (Oct 28, 2010) - San Diego
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7th DIA Japan Annual Meeting - (Oct 28, 2010) - Tokyo
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Future Direction for Orphan Drugs in Europe - (Nov 03, 2010) - Paris
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2nd Health Technology Assessment (HTA) Conference - (Nov 04, 2010) - Paris
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DIA/FDA Orphan Drug Designation Workshop - (Nov 04, 2010) - Lansdowne
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Understanding the Statistical Thinking in Clinical Research for Drug Development - (Nov 04, 2010) - Beijing
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DIA’s 8th Annual Canadian Meeting: Fostering Innovation and Access to Drugs - (Nov 04, 2010) - Ottawa
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Combination Products - Finding the Right Regulatory Strategy - (Nov 09, 2010) - Glattbrugg - Zurich
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Sustaining Clinical Trial Disclosure: Going Green - (Nov 09, 2010) - Bethesda
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7th Latin American Congress of Clinical Research: Harmonization and the Future of Drug Development in Latin America - (Nov 10, 2010) - São Paulo
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2nd Joint DIA/EMA/CMD(h) Variations Conference - (Nov 23, 2010) - London
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European Medicines Agency - ENCePP Information Day - (Nov 26, 2010) - London
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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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US and International Prescription Drug Labeling Comparisons and Important Updates - (Dec 08, 2010) -
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Pharmacovigilance and Risk Management 2011 - (Jan 09, 2011) - Washington
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14th Annual Workshop in Japan for Clinical Data Management - (Jan 27, 2011) - Tokyo
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CMC Workshop: Translating Science into Successful Regulatory Submissions - (Feb 07, 2011) - Washington
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Electronic Document Management 2011: The Intersection of Data, Documents and Submissions - (Feb 15, 2011) - National Harbor
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Marketing Pharmaceuticals 2011 - (Feb 21, 2011) -
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22nd Annual Workshop on Medical Communications - (Mar 08, 2011) - Carlsbad
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FDA/DIA Statistics Forum 2011 - (Apr 10, 2011) -
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Training Course
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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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Practical Guide for Pharmacovigilance: Clinical Trials and Post Marketing - (Aug 11, 2010) - Pretoria
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Training course on Medical Approach in Diagnosis and Management of ADRs - (Sep 13, 2010) - Boulogne-Billancourt (Paris)
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Training course on Clinical Statistics for Nonstatisticians - (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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IDMP Information Day - (Sep 17, 2010) - London
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Drug Safety Surveillance and Epidemiology - (Sep 20, 2010) - Horsham
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Training course on Clinical Project Management in Europe - Part I - (Sep 22, 2010) - Basel
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Training course on 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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Training Course for eCTD Submissions in Switzerland - (Sep 30, 2010) - Basel
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Regulatory Affairs Part II: The NDA Phase - (Oct 04, 2010) - Horsham
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Training course on Practical GCP Compliance Auditing of Trials & Systems - (Oct 06, 2010) - London
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Comprehensive Training on European Regulatory Affairs including Different Registration Procedures and Variations: Expert Overview - (Oct 06, 2010) - Prague 8
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Utilizing Chemistry, Manufacturing & Controls (CMC) in Drug Development - (Oct 07, 2010) - Horsham
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Training course on Introduction to Signal Detection and Data Mining in Pharmacovigilance - (Oct 07, 2010) - London
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Training course on how to Prepare for Pharmacovigilance Audits and Inspections - (Oct 08, 2010) - London
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Training course on Crisis Management: Focus on Pharmaceutical Product Crisis - (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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Training course on 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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Enterprise Resource Planning - (Oct 21, 2010) - Horsham
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Executing and Controlling Projects - (Oct 21, 2010) - Horsham
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Training course on Excellence in Pharmacovigilance: Clinical Trials and Post Marketing - (Oct 25, 2010) - Vienna
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Training course on: An Introduction to Product Information Management (PIM) - (Oct 28, 2010) - Geneva
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Training course on Quality by Design: A Hands-on Short Course for Pharma - (Nov 04, 2010) - Graz
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Introduction to Good Clinical Practices and Auditing - (Nov 08, 2010) - Horsham
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Training course on Essentials of Clinical Study Management - (Nov 10, 2010) - Lisbon
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Training course on Good Management of Medical Devices - (Nov 10, 2010) - Glattbrugg - Zurich
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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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Pre-marketing Clinical Safety & Pharmacovigilance - (Nov 15, 2010) - Horsham
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Clinical Project Management - (Nov 15, 2010) - Horsham
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Post-marketing Drug Safety & Pharmacovigilance - (Nov 17, 2010) - Horsham
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Project Risk Management - (Nov 18, 2010) - Horsham
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Training course on European Regulatory Affairs - (Nov 18, 2010) - Boulogne-Billancourt (Paris)
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Training course on Advanced GCP Study Monitoring - (Nov 19, 2010) - Boulogne-Billancourt (Paris)
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Introduction to Signal Detection and Data Mining - (Nov 19, 2010) - Horsham
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Training course on Non-Clinical Safety Sciences and Their Regulatory Aspects - (Nov 22, 2010) - Lisbon
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Training course on Practical Guide for Pharmacovigilance: Clinical Trials and Post Marketing - (Dec 01, 2010) - Paris
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Training course on CTD Dossier Requirements: Focus on EU Module 1 and Quality Module 3 - (Dec 05, 2010) - Dubai
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Overview of Drug Development - (Dec 08, 2010) - Horsham
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Training Course for eCTD Submissions in Switzerland - (Dec 09, 2010) - Zurich
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Tutorial
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HALF DAY TUTORIAL WORKSHOP I - WORKSHOP ON CEPS (CERTIFICATION PROCEDURES IN EUROPE) - (Sep 17, 2010) - Mumbai
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HALF DAY TUTORIAL WORKSHOP I - WORKSHOP ON WHO PREQUALIFICATION PROGRAMME FOR PRIORITY MEDICINES - (Sep 17, 2010) - Mumbai
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Tutorial #1 – Strategies on Developing and Deploying Semantic Linked Data to Biomedical Applications - (Oct 12, 2010) - National Harbor
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Tutorial #2 – Biomedical Informatics Tools for Preparing Observational Data for Active Surveillance and Outcomes Research - (Oct 12, 2010) - National Harbor
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Tutorial 1 - (Oct 23, 2010) - Bangalore
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Tutorial 2 - (Oct 23, 2010) - Bangalore
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Tutorial 3 - (Oct 23, 2010) - Bangalore
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Tutorial 4 - (Oct 23, 2010) - Bangalore
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Tutorial 5 - (Oct 23, 2010) - Bangalore
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Tutorial 6 - (Oct 23, 2010) - Bangalore
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An Overview of Signal Detection: See It, Analyze It, Deal with It - (Nov 03, 2010) - Ottawa
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Primer on Reimbursement - (Nov 03, 2010) - Ottawa
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Signal Detection, Case Assessment and Data Mining in Pharmacovigilance: Current State of the Art - (Jan 09, 2011) - Washington
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Periodic Safety Update Reports (PSURs): A Guide to the Construction and Analysis of PSURs, ASRs, and DSURs - (Jan 09, 2011) - Washington
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Roundtable 01: Inspection and Audit Findings (+7.6%) - (Mar 28, 2011) - Geneva
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Tutorial 02: The 'New' Variation Regulation in Practice – Advantages and pitfalls - (Mar 28, 2011) - Geneva
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Tutorial 03: Orphan Drugs in the EU; From Designation to Marketing Authorisation - (Mar 28, 2011) - Geneva
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Tutorial 04: Regulatory Requirements for the Development of Paediatric Medicinal Products - (Mar 28, 2011) - Geneva
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Tutorial 05: After the PIP Decision: Modification of the agreed PIP, validation and compliance check - (Mar 28, 2011) - Geneva
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Tutorial 06: Successful Outsourcing of Non Clinical Development Programmes - (Mar 28, 2011) - Geneva
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Webinar Archive
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ARCHIVED WEBINAR: CDER CFR Part 11 - Inspection Assignments - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR: Role of Medical Communications in Promotional Review - (Jul 31, 2010) - Online
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46th DIA Annual Meeting Live Learning Center - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR: FDA Discusses Guidance For Industry on Drug-Induced Liver Injury - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR: Understanding The Development and Label Allowances for 505(B)(2) Abuse- Deterrent Products - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR: DIA Trial Master File Reference Model – Overview and Implementation - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR: Guidance for Industry on the Contents of a Complete Submission for the Evaluation of Proprietary Names - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR: FDA Discusses the Draft Guidance on Adaptive Design Clinical Trials for Drugs and Biologics - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR: How CDRH Is Advancing Public Health through Innovation - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR: FDA Discusses Signaling Using Data Mining Results - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR: Update on AMCP Format Version 3.0: Industry Perspective - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR: CDER Town Meeting: Current Hot Topics Regarding eSubmissions - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR: Global Perspective on What Sites Need from Sponsors and CRO's - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR: Post Approval Changes (Variations) in the European Union Focusing on CMC - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR: Statistical Methods for Interval Censored Data - (Jul 31, 2010) - Online
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ARCHIVED: FDA eDRL Process - (Jul 31, 2010) - Online
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ARCHIVED: A New Approach to Large Observational Studies: “Local Control” Approach to Analysis - (Jul 31, 2010) - Online
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ARCHIVED: Critical Path Webinar Series- Part 1 - Standards for Emerging Biomarkers - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR: Innovative Medicines Initiative - Better Tools for Better Medicines - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR: Safety and Ethical Emerging Issues Impacting Patient Recruitment and Retention - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR: New REMS Draft Guidance Issued by FDA - (Jul 31, 2010) - Online
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ARCHIVED - Cardiac Safety Issues in Early Drug Development - (Jul 31, 2010) - Online
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ARCHIVED - Choosing the Appropriate Electronic Data Capture Hosting Model - (Jul 31, 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) - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR: Do Subvisible Particles Contribute to the Immunogenicity of Therapeutic Proteins? - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR: CMC Issues and 505(b)(2) Submissions - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR: Ethical Considerations for Conducting Clinical Trials in the Emerging Markets - (Jul 31, 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 - (Jul 31, 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) - (Jul 31, 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 - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR: Pharmacovigilance from the Medical Writer Perspective - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR: Update on the Revised European Labeling Guideline – European Summary of Product Characteristics - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR: Patient-reported Outcome Measures: Announcing the Final FDA PRO Guidance - (Jul 31, 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 - (Jul 31, 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 - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR: Opioid Class REMS: What’s It All About? - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR: Expanding Clinical Research Beyond Borders: The Importance of Latin America - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR: Conducting Clinical Trials in India-Current Update on Opportunities and Challenges - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR: eCTD 101: An Overview and its Impact on the Regulatory Submissions Process - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR: Case Processing and Signal Detection: Business Process Optimization in Pharmacovigilance - (Jul 31, 2010) - Online
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WEBINAR ARCHIVE: FDA-CDER Discusses Activities to Reduce Preventable Medication Harm: REMS, Medication Errors, and Safe Use - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR - Medical Communications: A Focus on Quality and Compliance - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR - Communication Fundamentals for Clinical Trial Success: Mastering the DM Language - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR - Registries and Safety - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR - Clinical Trial Landscape in India Webinar Series – Part 1 -Worldwide Regulatory Landscape: Current Regulatory Initiatives in the US, Canada and EU - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR - How Strategic Partnerships Can Accelerate Pandemic Flu Vaccine Development - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR - Use of Foreign Trial Data for NDA Approval - (Jul 31, 2010) - Online
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ARCHIVED WEBINAR - Generic Biologics: Separating Science Fact from Science Fiction - (Jul 31, 2010) - Online
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Webinar
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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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WEBINAR: Structured Product Labeling – 2010 Update & Downstream Use of SPL Data - (Aug 12, 2010) - Online
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WEBINAR: CBER Town Meeting: Hot Topics in eSubmissions - (Aug 24, 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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Critical Chain in the Pharmaceutical Industry - (Sep 23, 2010) - Online
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WEBINAR: The Emergence of Digital Signatures in Clinical Operations - (Oct 05, 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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The 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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