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 indicates items that take place in your region |
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Annual Meeting
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Audio Conference
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eLearning
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Variations to Marketing Authorisation in Europe - (Feb 03, 2012) - Online
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Registration of Monoclonal Antibodies - (Feb 03, 2012) - Online
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The ANDA: Requirements for Obtaining FDA Approval for a Generic Product in the USA - (Feb 03, 2012) - Online
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Pharmacokinetics and Pharmacodynamics in Drug Registration - (Feb 03, 2012) - Online
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Introduction to the International Conference on Harmonization (ICH) - (Feb 03, 2012) - Online
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The Regulatory Development Cycle of a Drug - (Feb 03, 2012) - Online
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Basics of Pharmacovigilance - (Feb 03, 2012) - Online
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Basics of Clinical Trials - (Feb 03, 2012) - Online
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How to Register Medicinal Products through the Centralized Procedure - (Feb 03, 2012) - Online
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How to Register Medicinal Products through the Mutual Recognition Procedure - (Feb 03, 2012) - Online
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How to Maintain Marketing Approvals in Europe for Centrally Authorized Products - (Feb 03, 2012) - Online
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How to Register a New Drug in the USA - (Feb 03, 2012) - Online
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How to Register Medicinal Products through the Decentralized Procedure - (Feb 03, 2012) - Online
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Access to Unapproved Drugs through Compassionate Use - (Feb 03, 2012) - Online
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Regulatory Requirements for the Conduct of Clinical Trials in Europe - (Feb 03, 2012) - Online
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Orphan Drugs in the USA, European Union and Japan - (Feb 03, 2012) - Online
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Regulatory Requirements for the Submission of Investigational New Drug Applications in the USA (INDs) - (Feb 03, 2012) - Online
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Meeting Opportunities with Regulatory Agencies - (Feb 03, 2012) - Online
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Introduction to the European Union Institutions and Regulatory Authority - (Feb 03, 2012) - Online
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Introduction to US Institutions and Regulatory Authority (FDA) - (Feb 03, 2012) - Online
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Introduction to Japanese Institutions and Regulatory Authorities - (Feb 03, 2012) - Online
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Overview of the CTD and the eCTD - (Feb 03, 2012) - Online
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Crisis Management - (Feb 03, 2012) - Online
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Database Management - (Feb 03, 2012) - Online
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Literature Evaluation - (Feb 03, 2012) - Online
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Literature Searching - (Feb 03, 2012) - Online
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Medical Inquires - (Feb 03, 2012) - Online
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Medical Writing - (Feb 03, 2012) - Online
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Product Labeling - (Feb 03, 2012) - Online
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Regulatory Issues - (Feb 03, 2012) - Online
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Clinical Investigator: Module 1 - Study Preparation and Initiation - (Feb 03, 2012) - Online
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Clinical Investigator: Module 2 - Conducting The Study - (Feb 03, 2012) - Online
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Informed Consent - (Feb 03, 2012) - Online
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Statistics for Medical Communications Professionals - (Feb 03, 2012) - Online
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A Tour of FDA - (Feb 03, 2012) - Online
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A Tour of Health Canada - (Feb 03, 2012) - Online
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A Tour of Health Europe - (Feb 03, 2012) - Online
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Aspects of Regulatory History - (Feb 03, 2012) - Online
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Bioresearch Monitoring Program (BIMO): Introduction - (Feb 03, 2012) - Online
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The Clinical Development Process: Investigational Product, Plan, and Data Management - (Feb 03, 2012) - Online
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Drug Safety & Adverse Event Reporting - (Feb 03, 2012) - Online
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Ethical Review Boards - (Feb 03, 2012) - Online
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Ethics as the Foundation to Clinical Research - (Feb 03, 2012) - Online
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Awareness of FDA Inspections for Pharmaceutical Manufacturers - (Feb 03, 2012) - Online
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Biotechnology: An Overview of Compliance Considerations - (Feb 03, 2012) - Online
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Change Control - (Feb 03, 2012) - Online
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Clinical Trial Audits and Consequences of Non-Compliance - (Feb 03, 2012) - Online
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Computerized Systems Inspections in the Medical Device Industry - (Feb 03, 2012) - Online
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European Union Clinical Trials Directive - (Feb 03, 2012) - Online
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GMP Principals of SOPs - (Feb 03, 2012) - Online
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GMP Updates - Enforcement Changes at the New FDA - (Feb 03, 2012) - Online
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GMPs for API Bulk Manufacturers - (Feb 03, 2012) - Online
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Good Clinical Practices (GCPs) for New Product Investigations - (Feb 03, 2012) - Online
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Good Laboratory Practices (GLPs) - (Feb 03, 2012) - Online
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GxPs - (Feb 03, 2012) - Online
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HIPAA - The Impact on Clinical Research - (Feb 03, 2012) - Online
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Introduction to GMPs - (Feb 03, 2012) - Online
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Investigational Product Development - (Feb 03, 2012) - Online
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ISO 14155: Obligations of Sponsors and Monitors for Medical Device Trials - (Feb 03, 2012) - Online
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Key Concepts of Process Validation - (Feb 03, 2012) - Online
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Laboratory Specimens for Clinical Research - (Feb 03, 2012) - Online
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Medical Device Safety Reporting - (Feb 03, 2012) - Online
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Orientation to GMP Compliance - (Feb 03, 2012) - Online
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Overview of the Clinical Research Process - (Feb 03, 2012) - Online
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Part 11: Electronic Records and Signatures - Application - (Feb 03, 2012) - Online
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Part 11: Electronic Records: Electronic Signatures - (Feb 03, 2012) - Online
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Principles of Good Documentation - (Feb 03, 2012) - Online
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Protection of Human Subjects in Clinical Trials - (Feb 03, 2012) - Online
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Selecting and Managing Clinical Contract Research Organizations (CROs) - (Feb 03, 2012) - Online
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Understanding Post-Approval Changes - (Feb 03, 2012) - Online
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Computerized Systems Inspections in the Pharmaceutical Industry - (Feb 03, 2012) - Online
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Basics of AdvaMed Code - (Feb 03, 2012) - Online
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Eucomed Guidelines on Interactions with Healthcare Professionals - (Feb 03, 2012) - Online
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Introduction to Medical Devices - (Feb 03, 2012) - Online
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Foreign Corrupt Practices Act - (Feb 03, 2012) - Online
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Global Anti-bribery - (Feb 03, 2012) - Online
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Basics of the PhRMA Code - (Feb 03, 2012) - Online
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EudraVigilance
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EudraVigilance training - Electronic Reporting of ICSRs in the EEA - (Feb 06, 2012) - London
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Extended EudraVigilance Medicinal Product Dictionary training course - (Feb 09, 2012) - London
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Extended EudraVigilance Medicinal Product Dictionary training course - (Feb 14, 2012) - London
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Extended EudraVigilance Medicinal Product Dictionary training course - (Feb 16, 2012) - London
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EudraVigilance training - Electronic Reporting of ICSRs in the EEA - (Mar 05, 2012) - London
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Extended EudraVigilance Medicinal Product Dictionary training course - (Mar 08, 2012) - London
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Extended EudraVigilance Medicinal Product Dictionary training course - (Mar 20, 2012) - London
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Extended EudraVigilance Medicinal Product Dictionary training course - (Mar 22, 2012) - London
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Extended EudraVigilance Medicinal Product Dictionary training course - (Apr 11, 2012) - London
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Introduction to Pharmacovigilance and Electronic Transmission of Individual Case Safety Reports (ICSR) for the use of Eudravigilance - (Apr 17, 2012) - London
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EudraVigilance training - Electronic Reporting of ICSRs in the EEA - (Apr 18, 2012) - London
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Extended EudraVigilance Medicinal Product Dictionary training course - (May 02, 2012) - London
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Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) - (May 07, 2012) - Horsham
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Extended EudraVigilance Medicinal Product Dictionary training course - (May 14, 2012) - London
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EudraVigilance training - Electronic Reporting of ICSRs in the EEA - (May 21, 2012) - London
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Extended EudraVigilance Medicinal Product Dictionary training course - (May 23, 2012) - London
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Extended EudraVigilance Medicinal Product Dictionary training course - (May 29, 2012) - London
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Extended EudraVigilance Medicinal Product Dictionary training course - (Aug 13, 2012) - London
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EudraVigilance - Electronic Reporting of ICSRs in the EEA - (Aug 20, 2012) - Horsham
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EudraVigilance training - Electronic Reporting of ICSRs in the EEA - (Sep 10, 2012) - London
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Extended EudraVigilance Medicinal Product Dictionary training course - (Sep 12, 2012) - London
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EudraVigilance training - Electronic Reporting of ICSRs in the EEA - (Sep 17, 2012) - London
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Extended EudraVigilance Medicinal Product Dictionary training course - (Sep 19, 2012) - London
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Extended EudraVigilance Medicinal Product Dictionary training course - (Oct 01, 2012) - London
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Introduction to Pharmacovigilance and Electronic Transmission of Individual Case Safety Reports (ICSR) for the use of Eudravigilance - (Oct 16, 2012) - London
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EudraVigilance training - Electronic Reporting of ICSRs in the EEA - (Oct 17, 2012) - London
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EudraVigilance training - Electronic Reporting of ICSRs in the EEA - (Oct 22, 2012) - London
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Extended EudraVigilance Medicinal Product Dictionary training course - (Oct 24, 2012) - London
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Extended EudraVigilance Medicinal Product Dictionary training course - (Oct 29, 2012) - London
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Extended EudraVigilance Medicinal Product Dictionary training course - (Nov 14, 2012) - London
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Introduction to Pharmacovigilance and Electronic Transmission of Individual Case Safety Reports (ICSR) for the use of Eudravigilance - (Nov 20, 2012) - London
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Extended EudraVigilance Medicinal Product Dictionary training course - (Nov 26, 2012) - London
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EudraVigilance training - Electronic Reporting of ICSRs in the EEA - (Dec 03, 2012) - London
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Extended EudraVigilance Medicinal Product Dictionary training course - (Dec 05, 2012) - London
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EudraVigilance training - Electronic Reporting of ICSRs in the EEA - (Dec 10, 2012) - London
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Extended EudraVigilance Medicinal Product Dictionary training course - (Dec 12, 2012) - London
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Extended EudraVigilance Medicinal Product Dictionary training course - (Dec 17, 2012) - London
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Euro Meeting
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In-Company Training
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Meeting
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CMC: Converting Science in to Regulatory Submission - (Feb 10, 2012) - Ahmedabad
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Marketing Pharmaceuticals 2012: Workshop for Regulatory/Legal/Communications Professionals and Promotional Review Teams - (Feb 16, 2012) - Washington
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Future Perspectives in Pharmacovigilance - (Mar 03, 2012) - Bangalore
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Medical Communications Workshop 2012 - (Mar 05, 2012) - Orlando
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FDA Information Day: Individual Case Safety Reports (ICSR) - (Mar 13, 2012) - Silver Spring
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FDA Information Day: Identification of Medicinal Products (IDMP) - (Mar 14, 2012) - Silver Spring
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Comparative Effectiveness: A Real-World User's Guide - (Mar 14, 2012) - Washington
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5th Regulatory Conference: Evolving Global Regulatory Requirements Environment - (Apr 13, 2012) - Mumbai
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DIA/FDA Oligonucleotide-based Therapeutics 2012: Leveraging Regulatory and Industry Knowledge for Future Advancements - (Apr 16, 2012) - Washington
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Cardiovascular Safety and State-of-the-art Development Issues: Type 2 Diabetes Mellitus Medications, QT, Benefit/Risk Assessment, Arrhythmias, Thrombosis, and Cardiotoxicity - (Apr 17, 2012) - Washington
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6th Annual FDA/DIA Statistics Forum - (Apr 23, 2012) - North Bethesda
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Clinical Data Quality Summit - (Apr 24, 2012) - Philadelphia
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Regulatory Information Management - (Apr 24, 2012) - Philadelphia
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6th European Forum for Qualified Person for Pharmacovigilance (QPPV) - (Apr 24, 2012) - London
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6th Annual Conference in Japan for Asian New Drug Development - (Apr 26, 2012) - Tokyo
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EudraVigilance Information Day - (Apr 27, 2012) - London
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3rd African Regulatory Conference (ARC) - Partnering for earlier access to good quality medicines in Africa - (May 03, 2012) - Accra
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The New Individual Case Safety Report (ICSR) International Standard and ICH E2B/M2 Information Day - (May 04, 2012) - London
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Latin American Regulatory Conference (LARC) 2012 - (May 15, 2012) -
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4th DIA China Annual Meeting: Collaboration & Innovation in China - (May 20, 2012) - Shanghai
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3rd DIA Cardiac Safety Workshop in Japan - (May 28, 2012) - Tokyo
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1st CMC Forum in Japan: Challenges for Quality Improvement in Asia - (Jun 11, 2012) - Tokyo
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Eudravigilance Information Day - (Sep 21, 2012) - London
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EDM / eSUBS - (Oct 08, 2012) - Baltimore
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6th Annual Clinical Forum - (Oct 08, 2012) - The Hague
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Satellite Conference
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Training Course
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EMA Excellence in Pharmacovigilance: Clinical Trials and Post-Marketing Training Course - (Feb 13, 2012) - London
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DIA European Regulatory Affairs Training Course - (Feb 16, 2012) - Vienna
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Information Day on the Implementation of Electronic Submission of Medicinal Product Information in the EU - (Feb 21, 2012) - London
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DIA Clinical Project Management Part II Training Course - (Feb 22, 2012) - Nice
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The 2nd Clinical Project Management Training Course - (Feb 23, 2012) - Shanghai
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The Leadership Experience - (Mar 05, 2012) - Orlando
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DIA Training Course on Building the eCTD: Practical Approaches to Compiling Electronic Submissions - (Mar 08, 2012) - Barcelona
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Regulatory Affairs Part I & II: The IND and NDA Phases - (Mar 11, 2012) - Irvine
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Premarketing Clinical Safety and Pharmacovigilance - (Mar 12, 2012) - Horsham
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Postmarketing Drug Safety and Pharmacovigilance - (Mar 14, 2012) - Horsham
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CTD Dossier - Global Quality, China and EU Module 1 Requirements - (Mar 14, 2012) - Beijing
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Regulatory Affairs for Biologics - (Mar 19, 2012) - Horsham
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Training course on Quality Risk Management (QRM) - (Mar 25, 2012) - Copenhagen S
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Development of a Clinical Study Report - (Mar 29, 2012) - Horsham
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Good Clinical Practices for Clinical Research Professionals - (Mar 30, 2012) - Horsham
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Risk Management and Safety Communications Strategies - (Apr 02, 2012) - Horsham
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Regulatory Affairs Part I: The IND Phase - (Apr 11, 2012) - Horsham
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Applying Pharmacokinetics and Pharmacodynamics for Regulatory Submissions - (Apr 16, 2012) - Bethesda
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Essentials of Project Management - (Apr 16, 2012) - Horsham
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Project Risk Management - (Apr 19, 2012) - Horsham
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Training Course on Paediatric Investigation Plans (PIP) - (Apr 23, 2012) - Amsterdam
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Introduction to Signal Detection and Data Mining - (Apr 23, 2012) - North Bethesda
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DIA Pre-Marketing Clinical Safety Training Course - (Apr 26, 2012) -
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Training Course on Chemistry, Manufacturing & Controls (CMC) - (May 08, 2012) - Vienna
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Training Course on Introduction to Signal Detection and Data Mining in Pharmacovigilance - (May 08, 2012) -
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Training Course on How to Prepare for Pharmacovigilance Audits and Inspections - (May 09, 2012) -
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DIA/EUCRAF Training Course on Authorisation of Biopharmaceuticals, Biosimilars and Advanced Therapies in Europe - (May 21, 2012) - Basel
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Practical Guide for Pharmacovigilance: Clinical Trials and Post-Marketing - (May 21, 2012) - Berlin
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Essentials of Clinical Study Management Training Course - (May 23, 2012) - Munich
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DIA Benefit/Risk Management Training Course - (May 24, 2012) - Munich
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DIA European Regulatory Affairs Training Course - (Jun 14, 2012) - Berlin
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#46: Fundamentals of Project Management for Non-project Managers - (Jun 24, 2012) - Philadelphia
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#47: Overview of Drug Development - (Jun 24, 2012) - Philadelphia
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#45: Preparing for a US FDA Advisory Committee Meeting - (Jun 24, 2012) - Philadelphia
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#48: The Art of Writing a Clinical Overview - (Jun 24, 2012) - Philadelphia
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New Drug Product Development and Life Cycle Management - (Aug 06, 2012) - Horsham
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Clinical Project Management - (Aug 08, 2012) - Horsham
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Regulatory Affairs Part I & II: The IND and NDA Phases - (Aug 13, 2012) - Boston
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Navigating Chemistry, Manufacturing & Controls through the Drug Development Process - (Sep 10, 2012) - Horsham
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Regulatory Affairs Part I: The IND Phase - (Sep 12, 2012) - Horsham
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Risk Management and Safety Communications Strategies - (Oct 01, 2012) - Horsham
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Introduction to Good Clinical Practices and Auditing - (Oct 01, 2012) - Horsham
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Regulatory Affairs Part II: The NDA Phase - (Oct 15, 2012) - Horsham
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Premarketing Clinical Safety and Pharmacovigilance - (Oct 15, 2012) - Boston
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Postmarketing Drug Safety and Pharmacovigilance - (Oct 17, 2012) - Boston
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DIA Practical GCP Compliance Auditing of Trials and Systems Training Course - (Oct 17, 2012) - London
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Preparing for a US FDA Advisory Committee Meeting - (Oct 18, 2012) - Horsham
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The Leadership Experience - (Oct 22, 2012) - San Diego
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European Regulatory Affairs - (Oct 22, 2012) - San Diego
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Clinical Statistics for Nonstatisticians - (Oct 29, 2012) - Horsham
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Regulatory Affairs Part I & II: The IND and NDA Phases - (Nov 12, 2012) - Philadelphia
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DIA European Regulatory Affairs Training Course - (Nov 15, 2012) - Paris
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DIA Non-Clinical Safety Sciences and Their Regulatory Aspects Training Course - (Nov 19, 2012) - Lisbon
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Applying Pharmacokinetics and Pharmacodynamics for Regulatory Submissions - (Nov 29, 2012) - Crystal City
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Tutorial
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Tutorial: OPDP/APLB and Compliance 101: A Primer - (Feb 15, 2012) - Washington
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Core Curriculum - (Mar 04, 2012) - Orlando
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Tutorial 2 - Compliance - (Mar 05, 2012) - Orlando
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Tutorial 3 - Statistics for Medical Communications - (Mar 05, 2012) - Orlando
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Tutorial 1 - Principles of Promotional Review - (Mar 05, 2012) - Orlando
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Tutorial #1 - Multiplicity Issues in Clinical Trials - (Apr 22, 2012) - North Bethesda
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Tutorial #2 - Data Monitoring Committee Concepts and Practices - (Apr 22, 2012) - North Bethesda
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Tutorial - 6th Annual Conference - (Apr 27, 2012) - Tokyo
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#25: Benefit and Harm: A Process to Express This Ratio Determined by Consensus Driven Evidence - (Jun 24, 2012) - Philadelphia
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#23: Global Market Access: Essential Knowledge for Clinical Trial Design - (Jun 24, 2012) - Philadelphia
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#24: A Device Primer: 510(k)s, PMAs, IDEs - (Jun 24, 2012) - Philadelphia
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#20: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical Development - (Jun 24, 2012) - Philadelphia
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#21: FDA Enforcement: Understanding the Agency's Authority, How Violations Occur, How to Prevent Them, and How to Respond If Violations Do Occur - (Jun 24, 2012) - Philadelphia
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#22: Utilizing Chemistry Manufacturing and Controls in Drug Development - (Jun 24, 2012) - Philadelphia
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#41: Quality Oversight of CROs - Clinical Vendors - (Jun 24, 2012) - Philadelphia
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#42: Regulatory Affairs for Biologics - (Jun 24, 2012) - Philadelphia
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#40: Understanding and Navigating the Regulatory System in China - (Jun 24, 2012) - Philadelphia
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#43: Clinical Statistics for Nonstatisticians - (Jun 24, 2012) - Philadelphia
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#44: Early Phase Research: Navigating the 21st Century Landscape for Phase I Trials - (Jun 24, 2012) - Philadelphia
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#33: Understanding Comparative Effectiveness Research (CER) in the Biopharmaceutical Industry - (Jun 24, 2012) - Philadelphia
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#30: Regulatory Affairs in the European Union: An Overview of Registration Procedures for Medicinal Products in the EU - (Jun 24, 2012) - Philadelphia
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#31: Leadership: How to Organize and Lead People in Group Work - (Jun 24, 2012) - Philadelphia
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#32: Designing, Operating and Evaluating Patient Registries - (Jun 24, 2012) - Philadelphia
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#34: Fourteen Steps from Research to Development - (Jun 24, 2012) - Philadelphia
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Webinar
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WEBINAR: CDER-CBER Town Meeting: FDA Discusses the US Module 1 Update - (Feb 09, 2012) - Online
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The Art of Writing a Clinical Overview - (Feb 13, 2012) - Online
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WEBINAR: The Future of SPL: What’s Next? Part 3 - The Present and Future of SPL: Uses of SPL by the Drug Compendia - (Feb 14, 2012) - Online
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Webinar: How to Lead and Deliver Value as a Medical Science Liaison: The $64,000 Question - (Feb 16, 2012) - Online
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WEBINAR: The Future of SPL: What’s Next? Part 4 - SPL Use in the Life Sciences Industry - (Feb 21, 2012) - Online
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WEBINAR: The Patient-Centered Outcomes Research Institute’s National Priorities and Research Agenda - (Feb 23, 2012) - Online
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Clinical Statistics for Nonstatisticians - (Feb 27, 2012) - Online
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WEBINAR: CDER Town Meeting: Safety Hot Topics - (Mar 08, 2012) - Online
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Fundamentals of Clinical Research Monitoring - (Mar 19, 2012) - Online
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WEBINAR: Meeting Global Patient Demand for Access to Medicines Prior to Approval and Launch - (Mar 20, 2012) - Online
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How to Prepare for a Safety Inspection - (Apr 10, 2012) - Online
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Proven Strategies for Creating an Effective Clinical Research Program - (Apr 16, 2012) - Online
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European Regulatory Affairs - (Apr 20, 2012) - Online
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Enterprise Resource Management - (Apr 23, 2012) - Online
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Introduction to Computer Systems Validation - (Apr 30, 2012) - Online
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Basics of the IND - (Apr 30, 2012) - Online
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Who's Monitoring the Monitor? - (May 04, 2012) - Online
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Overview of Drug Development in Japan - (May 08, 2012) - Online
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Developing Standard Operating Procedures - (May 09, 2012) - Online
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Basics of the NDA - (May 14, 2012) - Online
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Interactions with the FDA During the IND/NDA Phases - (Jun 04, 2012) - Online
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Regulatory Aspects of Prescription Drug/Biologics Advertising & Promotional Labeling - (Jun 07, 2012) - Online
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Regulatory Considerations for Clinical Development Programs - (Jun 11, 2012) - Online
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Adverse Event Reporting Requirements: IND and Post-marketing - (Jul 09, 2012) - Online
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Executing and Controlling Biopharmaceutical Projects - (Jul 10, 2012) - Online
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Advanced Clinical Statistics for Nonstatisticians - (Jul 16, 2012) - Online
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Supplements and Other Changes to an Approved Application - (Jul 30, 2012) - Online
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Introduction to Portfolio Management and Performance Metrics - (Aug 02, 2012) - Online
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Good Clinical Practices for the Clinical Research Professional - (Sep 11, 2012) - Online
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Introduction to Clinical Data Management - (Sep 12, 2012) - Online
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Project Information, Communication and Knowledge Management - (Sep 27, 2012) - Online
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Introduction to Signal Detection and Data Mining - (Oct 01, 2012) - Online
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Development of a Clinical Study Report - (Oct 29, 2012) - Online
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Overview of Drug Development - (Nov 05, 2012) - Online
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Webinar Archive
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ARCHIVED WEBINAR: Using Patient-reported Outcomes to Assess Comparative Safety and Tolerability: Methodological and Regulatory Considerations - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: Steps to Preparing for a Successful FDA Advisory Committee Meeting - (Feb 03, 2012) - Online
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Investigator Responsibilities: The Good, The Bad, and the Ugly - (Feb 03, 2012) - Online
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Navigating the Regulatory Landscape - Setting Your GPS to Avoid Compliance Pitfalls - (Feb 03, 2012) - Online
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Identifying the Best Early Phase Site for the Study.... Are You That Site? - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: Three-part Series - Drug-Induced Liver Injury (DILI) Across Rx – OTC – NHP: Part 3 - NHP Session: Risks and Benefits of Natural Health Products (NHP) in DILI - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: Part 2 of 3 - Drug-Induced Liver Injury (DILI) Across Rx – OTC – NHP: Post-approval Surveillance: DILI Risk Management Post Marketing - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: 510(k) Device Modifications – Deciding When to Submit a 510(k) for a Change to an Existing Device - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: Three-part Series - Drug-Induced Liver Injury (DILI) Across Rx – OTC – NHP: Part 1 - Rx Session DILI: Challenges in DILI Management with Pre-approved or Post Approved Products - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: Medical Information Responses: What’s Everyone Saying? - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: Pharmacovigilance Series - Part 2: Pharmacovigilance for Co-marketed Products: Identifying and Overcoming Potential Obstacles - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: Pharmacovigilance Series Part 3 - Closing the Gap between Safety Signaling and Confirmatory Studies - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: Overview of FDA Guidance for Industry on Submission of Summary Bioequivalence Data for ANDAs - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: Pharmacovigilance Series - Part 1: Out with the Old, In with the New: Operational Implications for the New European Pharmacovigilance Legislation - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: Electronic Submission Basics 3-part Series: Part 1: eSubs 101: The Transition from Paper - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: Trial Master File Webinar Series Part 1: The Trial Master File—What’s In It and How Is It Managed? - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: Electronic Submission Basics: 3-part Webinar Series: Part 2-eCTD 101: Concepts of the eCTD Standard - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: Electronic Submission Basics Webinar Part 3: RPS 101: Introduction to the RPS (Regulated Product Submissions) Standard - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: Trial Master File Webinar Series Part 2: TMF Process Quality Improvements—A Sponsor Case Study and the DIA TMF Reference Model - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: Trial Master File Webinar Series Part 3: Moving from a Paper to an Electronic Process for Management of TMF Content - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: Trial Master File Webinar Series Part 4: Management and Maintenance of eTMF Content - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: REMS and Scheduled Opioid Medications: A Review and Critique - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: Two-part Series: What You Need to Know about FDA’s Drug Listing and Import Process: Part 1- Drug Listing/Regulatory Perspective - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: Two-part Series: What You Need to Know about FDA’s Drug Listing and Import Process-Part 2 Importation Perspective - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: CDER Data Standards Common Issues Document - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: The “Nuts and Bolts” of Preparing a New Drug Application (NDA): Industry and FDA Perspectives - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: Bridging the Gap Between Images and Data Management for Clinical Trials - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: Pharmaceuticals and Companion Diagnostics: Regulation and Reimbursement - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: Source Documentation, Audit Trails and EDC, How Do They Fit Together? - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: CDER Town Meeting: Safety Hot Topics - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: Recent Trends in Drug and Device Approvals and Clearance, and the Potential Impact of FDA/CMS Parallel Review - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: FDA's Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: Multiregional Clinical Trials Series-Part 1: Regulatory and Industry Perspectives on MRCTs - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: Five-part Labeling Series - Part 1: Safety Information in the Canadian Product Monograph: Writing the Adverse Reactions, Warnings and Precautions, Contraindications and Drug Interaction Information - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: Five-Part Labeling Series - Part 2: Safety Information in the EU: Summary of Product Characteristics - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: The Clinical Study Budget Secret - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: Five-part Labeling Series - Part 3: US Prescribing Information - Writing the Highlights - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: Evaluating IRBs: Finding an IRB that is Compliant, Provides High Quality and Customer Service - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: Five-part Labeling Series - Part 4: Safety Information in the US Prescribing Information: Writing the Adverse Reactions, Warnings and Precautions, Contraindications and Boxed Warnings Sections - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: Five-part Labeling Series - Part 5: Safety Information in Japanese Prescription Drug Labeling - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: Multiregional Clinical Trials (MRCT) Webinar Series - Part 2: Special Presentation: Quality by Design (QbD) for MRCTs - (Feb 03, 2012) - Online
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ARCHIVED WEBINAR: 2011 Guidance for Industry Process Validation: General Principles and Practices - (Feb 03, 2012) - Online
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