|
Basics of the NDA
|
May 20, 2013
|
IACET
|
Online Instruction
|
Global
|
Online
|
|
14th Eudravigilance Information Day
|
May 23, 2013
|
|
In-Person Instruction
|
Europe
|
London, United Kingdom
|
|
6th Regulatory Conference
|
May 23, 2013
|
|
Meetings
|
India
|
Ahmedabad, India
|
|
Certificates of Pharmaceutical Products for Regulatory Submissions
|
May 23, 2013
|
IACET
|
Online Instruction
|
Global
|
Online
|
|
eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD)
|
May 27, 2013
|
|
In-Person Instruction
|
Europe
|
Athens, Greece
|
|
Electronic reporting of ICSRs in the EEA
|
May 27, 2013
|
|
In-Person Instruction
|
Europe
|
Athens, Greece
|
|
Good Clinical Practices for the Clinical Research Professional
|
May 29, 2013
|
ACPE, IACET
|
Online Instruction
|
Global
|
Online
|
|
FDA and the Freedom of Information Act: The Unredacted Story
|
May 30, 2013
|
IACET
|
Online Instruction
|
Global
|
Online
|
|
Electronic reporting of ICSRs in the EEA
|
Jun 03, 2013
|
|
In-Person Instruction
|
Europe
|
Berlin, Germany
|
|
Impact of the New Pharmacovigilance Legislation on Regulatory Affairs
|
Jun 04, 2013
|
|
Meetings
|
Europe
|
London, United Kingdom
|
|
Regulatory Aspects of Prescription Drug/Biologics Advertising and Promotional Labeling
|
Jun 04, 2013
|
IACET
|
Online Instruction
|
Global
|
Online
|
|
Essentials for Comparative Effectiveness Research for Medical Affairs and Health Care Professionals
|
Jun 05, 2013
|
ACPE, IACET
|
Online Instruction
|
Global
|
Online
|
|
Drug & Cosmetic Rule Amendments: Changes in Regulations Governing Clinical Trials in India
|
Jun 06, 2013
|
IACET
|
Online Instruction
|
Global
|
Online
|
|
European Regulatory Affairs: In-depth review of current registration procedures in the European Union
|
Jun 06, 2013
|
|
In-Person Instruction
|
Europe
|
Basel, Switzerland
|
|
Good Management of Medical Devices including In Vitro Diagnostics and Companion Diagnostics: Legal and practical aspects of devices
|
Jun 10, 2013
|
|
In-Person Instruction
|
Europe
|
Amsterdam, Netherlands
|
|
2nd CMC Forum in Japan
|
Jun 10, 2013
|
|
Meetings
|
Japan
|
Tokyo, Japan
|
|
Signal Management in Pharmacovigilance
|
Jun 10, 2013
|
|
In-Person Instruction
|
Europe
|
Nice, France
|
|
How to Prepare for Pharmacovigilance Audits and Inspections
|
Jun 11, 2013
|
|
In-Person Instruction
|
Europe
|
Nice, France
|
|
EudraVigilance - electronic reporting of ICSRs in the EEA
|
Jun 12, 2013
|
|
In-Person Instruction
|
Europe
|
Madrid, Spain
|
|
2nd FDA IND/NDA Training Course in Japan
|
Jun 12, 2013
|
|
In-Person Instruction
|
Japan
|
Tokyo, Japan
|
|
Assessing the Benefits and Risks of Medicines: Webinar Series- Part 7: A Structured, Quantitative Health Outcomes Approach to Drug Benefit-Risk Analysis
|
Jun 12, 2013
|
ACPE, IACET
|
Online Instruction
|
Global
|
Online
|
|
Supplements and Other Changes to an Approved Application
|
Jun 12, 2013
|
IACET
|
Online Instruction
|
Global
|
Online
|
|
Introduction to Pharmacovigilance and Electronic Transmission of Individual Case Safety Reports (ICSRs) for the Use of Eudravigilance
|
Jun 18, 2013
|
|
In-Person Instruction
|
Europe
|
London, United Kingdom
|
|
1st Information Day on Periodic Safety Update Reports -ICH E2C(R2) Periodic Benefit-Risk Evaluation Reports (PBRERs)
|
Jun 19, 2013
|
|
In-Person Instruction
|
Europe
|
London, United Kingdom
|
|
Electronic reporting of ICSRs in the EEA
|
Jun 19, 2013
|
|
In-Person Instruction
|
Europe
|
London, United Kingdom
|
|
DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science
|
Jun 23, 2013
|
ACPE, CME, IACET, RN, PMI
|
Meetings
|
North America
|
Boston, MA, United States
|
|
Electronic reporting of ICSRs in the EEA
|
Jun 26, 2013
|
|
In-Person Instruction
|
Europe
|
Zagreb, Croatia (Hrvatska)
|
|
4th Cardiac Safety Workshop in Japan
|
Jul 11, 2013
|
|
Meetings
|
Japan
|
Tokyo, Japan
|
|
Advanced Clinical Statistics for the Nonstatistician
|
Jul 16, 2013
|
ACPE, IACET
|
Online Instruction
|
Global
|
Online
|
|
New Good Pharmacovigilance Practice (GVP) documents in Canada
|
Jul 17, 2013
|
IACET
|
Online Instruction
|
Global
|
Online
|
|
Regulating a Social World
|
Jul 18, 2013
|
IACET
|
Online Instruction
|
Global
|
Online
|
|
Interactions with the FDA During the IND/NDA Phases
|
Jul 23, 2013
|
IACET
|
Online Instruction
|
Global
|
Online
|
|
Assessing the Benefits and Risks of Medicines: Webinar Series- Part 8: Visualization and Communication of Benefit-Risk
|
Jul 24, 2013
|
ACPE, IACET
|
Online Instruction
|
Global
|
Online
|
|
Adverse Event Reporting Requirements: IND and Postmarketing
|
Jul 30, 2013
|
IACET
|
Online Instruction
|
Global
|
Online
|
|
Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum
|
Aug 12, 2013
|
ACPE, IACET
|
In-Person Instruction
|
North America
|
Boston, MA, United States
|
|
Regulatory Affairs: The IND, NDA, and Postmarketing
|
Aug 12, 2013
|
IACET
|
In-Person Instruction
|
North America
|
Boston, MA, United States
|
|
Clinical Project Management
|
Aug 12, 2013
|
IACET, PMI
|
In-Person Instruction
|
North America
|
Boston, MA, United States
|
|
New Drug Product Development and Life Cycle Management
|
Aug 14, 2013
|
IACET, PMI
|
In-Person Instruction
|
North America
|
Boston, MA, United States
|
|
Overview of Drug Development in Japan
|
Aug 14, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Art of Writing a Clinical Overview
|
Sep 09, 2013
|
IACET
|
In-Person Instruction
|
North America
|
Horsham, PA, United States
|
|
Strategies for Good Clinical Practice Audits
|
Sep 09, 2013
|
IACET, RN
|
Online Instruction
|
Global
|
Online
|
|
Planning and Managing Your Project
|
Sep 10, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Quality by Design for Chemical and Biotech Products – A hands-on course for the pharmaceutical industry and regulators
|
Sep 11, 2013
|
|
In-Person Instruction
|
Europe
|
Vienna, Austria
|
|
Measurement in Clinical Trials: An Examination of the FDA Position on the Review of Clinical Outcome Assessments (COAs)
|
Sep 12, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Electronic reporting of ICSRs in the EEA
|
Sep 16, 2013
|
|
In-Person Instruction
|
Europe
|
London, United Kingdom
|
|
Introduction to Clinical Data Management
|
Sep 17, 2013
|
IACET
|
Online Instruction
|
Global
|
Online
|
|
Authorisation of Biopharmaceuticals, Biosimilars and Advanced Therapies in Europe
|
Sep 18, 2013
|
|
In-Person Instruction
|
Europe
|
Basel, Switzerland
|
|
Clinical Project Management - Part I
|
Sep 18, 2013
|
|
In-Person Instruction
|
Europe
|
Basel, Switzerland
|
|
Implication of Comparative Effectiveness Research for Clinical Research Organizations
|
Sep 18, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Change Management, Issues Management, Escalation Management
|
Sep 18, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Diagnosis and Management of Drug-Induced Liver Injury (DILI)
|
Sep 19, 2013
|
|
In-Person Instruction
|
Europe
|
Paris, France
|
|
Clinical Aspects of Quality Risk Management and Quality by Design
|
Sep 19, 2013
|
|
In-Person Instruction
|
Europe
|
Basel, Switzerland
|
|
ICH Endorsed Pharmacovigilance
|
Sep 22, 2013
|
|
In-Person Instruction
|
Europe
|
Muscat, Oman
|
|
Regulatory Affairs for Biologics
|
Sep 23, 2013
|
IACET
|
In-Person Instruction
|
North America
|
Horsham, PA, United States
|
|
Electronic reporting of ICSRs in the EEA
|
Sep 23, 2013
|
|
In-Person Instruction
|
Europe
|
London, United Kingdom
|
|
10th Middle East Regulatory Conference (MERC) 2013
|
Sep 24, 2013
|
|
Meetings
|
Europe
|
Muscat, Oman
|
|
The Development of Live Biotherapeutics
|
Sep 24, 2013
|
|
Meetings
|
North America
|
Rockville, MD, United States
|
|
7th DIA / EFGCP / EMA Medicines for Children Conference
|
Sep 24, 2013
|
|
Meetings
|
Europe
|
London, United Kingdom
|
|
DIA/FDA Oligonucleotide-based Therapeutics Conference
|
Sep 25, 2013
|
|
Meetings
|
North America
|
Washington, DC, United States
|
|
Benefit/Risk Management
|
Sep 26, 2013
|
|
In-Person Instruction
|
Europe
|
Prague, Czech Republic
|
|
Optimizing Expectations and Success in Support of First-in-Human (FIH) Trials with Stem Cell Therapies
|
Sep 26, 2013
|
|
Meetings
|
North America
|
Washington, DC, United States
|
|
eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD)
|
Sep 26, 2013
|
|
In-Person Instruction
|
Europe
|
London, United Kingdom
|
|
Clinical Trial Disclosure: Towards a More Transparent World
|
Oct 01, 2013
|
IACET
|
Meetings
|
North America
|
Bethesda, MD, United States
|
|
Basics of the IND
|
Oct 01, 2013
|
IACET
|
Online Instruction
|
Global
|
Online
|
|
The Impact of Regulatory Affairs on Chemistry, Manufacturing & Controls (CMC)
|
Oct 02, 2013
|
|
In-Person Instruction
|
Europe
|
Basel, Switzerland
|
|
Joint MHRA/DIA Statistics Workshop
|
Oct 02, 2013
|
|
Meetings
|
Europe
|
|
|
Preparing a Clinical Trial Budget
|
Oct 02, 2013
|
IACET
|
Online Instruction
|
Global
|
Online
|
|
US Conference on Rare Diseases and Orphan Products: The New Era in Health Care
|
Oct 07, 2013
|
|
Meetings
|
North America
|
North Bethesda, MD, United States
|
|
Clinical Statistics for Nonstatisticians
|
Oct 07, 2013
|
ACPE, IACET
|
In-Person Instruction
|
North America
|
Horsham, PA, United States
|
|
7th Annual Clinical Forum - Rebooting Clinical Development
|
Oct 08, 2013
|
|
Meetings
|
Global
|
Dublin 1, Ireland
|
|
Introduction to Pharmacovigilance and Electronic Transmission of Individual Case Safety Reports (ICSRs) for the Use of Eudravigilance
|
Oct 08, 2013
|
|
In-Person Instruction
|
Europe
|
London, United Kingdom
|
|
Electronic reporting of ICSRs in the EEA
|
Oct 09, 2013
|
|
In-Person Instruction
|
Europe
|
London, United Kingdom
|
|
The Current State of Quality Oversight (QO) in the Pharmaceutical Industry
|
Oct 09, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Electronic reporting of ICSRs in the EEA
|
Oct 14, 2013
|
|
In-Person Instruction
|
Europe
|
London, United Kingdom
|
|
Drug-Induced Injury of Liver, Heart, Kidney, and Skin: Employing Recent Advances to Improve Patient Safety and Speed Up the Pipeline
|
Oct 15, 2013
|
|
Meetings
|
North America
|
North Bethesda, MD, United States
|
|
Health Authority Interactions - Preperation, consultation and implementation
|
Oct 15, 2013
|
|
In-Person Instruction
|
Europe
|
Vienna, Austria
|
|
EDM and ERS/eCTD: Impact of e-Initiatives on Content and Context
|
Oct 15, 2013
|
|
Meetings
|
North America
|
San Diego, CA, United States
|
|
Developing Global Animal Health Products to Support Food Security and Sustainability
|
Oct 17, 2013
|
IACET
|
Meetings
|
North America
|
Arlington, VA, United States
|
|
Global Considerations for Regulatory Strategy Development
|
Oct 17, 2013
|
IACET
|
In-Person Instruction
|
North America
|
Horsham, PA, United States
|
|
eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD)
|
Oct 17, 2013
|
|
In-Person Instruction
|
Europe
|
London, United Kingdom
|
|
10th Latin American Conference of Clinical Research
|
Oct 20, 2013
|
|
Meetings
|
LATIN AMERICA
|
São Paulo, SP, Brazil
|
|
Postmarketing Drug Safety and Pharmacovigilance
|
Oct 21, 2013
|
ACPE, IACET
|
In-Person Instruction
|
North America
|
Horsham, PA, United States
|
|
Basics of the NDA
|
Oct 22, 2013
|
IACET
|
Online Instruction
|
Global
|
Online
|
|
Practical GCP Compliance Auditing of Trials and Systems
|
Oct 23, 2013
|
|
In-Person Instruction
|
Europe
|
London, United Kingdom
|
|
Clinical Statistics for Non-Statisticians
|
Oct 24, 2013
|
|
In-Person Instruction
|
Europe
|
London, United Kingdom
|
|
DIA's Annual Canadian Meeting: New Reality / New Frontiers
|
Oct 29, 2013
|
|
Meetings
|
North America
|
Ottawa, ON, Canada
|
|
Negotiation and Influence
|
Oct 30, 2013
|
IACET, PMI
|
Online Instruction
|
Global
|
Online
|
|
Navigating Chemistry, Manufacturing & Controls Through the Drug Development Process
|
Nov 04, 2013
|
|
In-Person Instruction
|
North America
|
Horsham, PA, United States
|
|
Risk Management and Safety Communications Strategies
|
Nov 04, 2013
|
ACPE, IACET
|
In-Person Instruction
|
North America
|
Horsham, PA, United States
|
|
US Regulatory Affairs: A Comprehensive Review of Regulatory Procedures for INDs and NDAs in the US
|
Nov 06, 2013
|
|
In-Person Instruction
|
Europe
|
Paris, France
|
|
Signal Management in Pharmacovigilance
|
Nov 06, 2013
|
|
In-Person Instruction
|
Europe
|
Paris, France
|
|
Team Building and Development
|
Nov 06, 2013
|
IACET
|
Online Instruction
|
Global
|
Online
|
|
Project Risk Management: Dealing with the Certainty of Uncertainty
|
Nov 07, 2013
|
IACET, PMI
|
Online Instruction
|
Global
|
Online
|
|
How to Prepare for Pharmacovigilance Audits and Inspections
|
Nov 07, 2013
|
|
In-Person Instruction
|
Europe
|
Paris, France
|
|
Preparing for a US FDA Advisory Committee Meeting
|
Nov 10, 2013
|
IACET
|
In-Person Instruction
|
North America
|
Philadelphia, PA, United States
|
|
Regulatory Affairs: The IND, NDA, and Postmarketing
|
Nov 11, 2013
|
IACET
|
In-Person Instruction
|
North America
|
Philadelphia, PA, United States
|
|
The Leadership Experience
|
Nov 11, 2013
|
IACET, PMI
|
In-Person Instruction
|
North America
|
Philadelphia, PA, United States
|
|
Introduction to Pharmacovigilance and Electronic Transmission of Individual Case Safety Reports (ICSRs) for the Use of Eudravigilance
|
Nov 12, 2013
|
|
In-Person Instruction
|
Europe
|
London, United Kingdom
|
|
DIA Biosimilars 2013
|
Nov 13, 2013
|
|
Meetings
|
North America
|
Bethesda, MD, United States
|
|
Electronic reporting of ICSRs in the EEA
|
Nov 13, 2013
|
|
In-Person Instruction
|
Europe
|
London, United Kingdom
|
|
EMA Excellence in Pharmacovigilance: Clinical trials and post-marketing
|
Nov 18, 2013
|
|
In-Person Instruction
|
Europe
|
London, United Kingdom
|
|
Essentials of Clinical Study Management
|
Nov 20, 2013
|
|
In-Person Instruction
|
Europe
|
Paris, France
|
|
14th DIA Conference on European Electronic Document Management
|
Nov 21, 2013
|
|
Meetings
|
Europe
|
Dublin 4, Ireland
|
|
European Regulatory Affairs: In-depth review of current registration procedures in the European Union
|
Nov 21, 2013
|
|
In-Person Instruction
|
Europe
|
|
|
Clinical Project Management Part II
|
Nov 25, 2013
|
|
In-Person Instruction
|
Europe
|
Zurich, Switzerland
|
|
Electronic reporting of ICSRs in the EEA
|
Nov 25, 2013
|
|
In-Person Instruction
|
Europe
|
London, United Kingdom
|
|
Health Technology Assessment (HTA)
|
Nov 26, 2013
|
|
In-Person Instruction
|
Europe
|
Zurich, Switzerland
|
|
eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD)
|
Nov 28, 2013
|
|
In-Person Instruction
|
Europe
|
London, United Kingdom
|
|
Global CTD Dossier – Regulatory aspects and focus on quality documentation including concepts of Quality by Design
|
Dec 01, 2013
|
|
In-Person Instruction
|
Europe
|
Dubai, United Arab Emirates
|
|
Electronic reporting of ICSRs in the EEA
|
Dec 02, 2013
|
|
In-Person Instruction
|
Europe
|
London, United Kingdom
|
|
Pharmacovigilance and Risk Management Strategies 2014
|
Jan 13, 2014
|
|
Meetings
|
North America
|
Washington, DC, United States
|
|
#20: Japan's Regulatory Environment: Overview of the Organization, Processes, Systems and Changes Affecting Pharmaceutical Development
|
Jun 23, 2013
|
IACET
|
In-Person Instruction
|
North America
|
Boston, MA, United States
|
|
#21: FDA Enforcement: Understanding the Agency's Authority, How Violations Occur, How to Prevent Them and How to Respond if Violations Do Occur
|
Jun 23, 2013
|
IACET
|
In-Person Instruction
|
North America
|
Boston, MA, United States
|
|
#22: Global Reimbursement Systems: A Market Access Perspective
|
Jun 23, 2013
|
IACET
|
In-Person Instruction
|
North America
|
Boston, MA, United States
|
|
#23: A Device Primer: 510(k)s, PMAs, IDEs
|
Jun 23, 2013
|
CME, IACET
|
In-Person Instruction
|
North America
|
Boston, MA, United States
|
|
#25: Leadership: How to Organize and Lead People in Group Work
|
Jun 23, 2013
|
IACET, PMI
|
In-Person Instruction
|
North America
|
Boston, MA, United States
|
|
#50: Understanding and Navigating the Regulatory System in China
|
Jun 23, 2013
|
IACET
|
In-Person Instruction
|
North America
|
Boston, MA, United States
|
|
#51: Quality Oversight of CROs-Clinical Vendors
|
Jun 23, 2013
|
IACET
|
In-Person Instruction
|
North America
|
Boston, MA, United States
|
|
#52: Regulatory Affairs for Biologics
|
Jun 23, 2013
|
IACET
|
In-Person Instruction
|
North America
|
Boston, MA, United States
|
|
#53: Clinical Statistics for Nonstatisticians
|
Jun 23, 2013
|
ACPE, CME, IACET
|
In-Person Instruction
|
North America
|
Boston, MA, United States
|
|
#54: Art of Writing a Clinical Overview
|
Jun 23, 2013
|
IACET
|
In-Person Instruction
|
North America
|
Boston, MA, United States
|
|
#55: Overview of Drug Development
|
Jun 23, 2013
|
IACET, PMI
|
In-Person Instruction
|
North America
|
Boston, MA, United States
|
|
#56: Risk Communications
|
Jun 23, 2013
|
ACPE, CME, IACET, RN
|
In-Person Instruction
|
North America
|
Boston, MA, United States
|
|
#57: Preparing for a US FDA Advisory Committee Meeting
|
Jun 23, 2013
|
IACET
|
In-Person Instruction
|
North America
|
Boston, MA, United States
|
|
#30: Analysis of Safety Data from Clinical Trials
|
Jun 23, 2013
|
ACPE, CME, IACET
|
In-Person Instruction
|
North America
|
Boston, MA, United States
|
|
#31: Highlights of the New Pharmacovigilance Legislation in the EU: Key Points to be Taken into Account for Successful Implementation and Lessons Learned
|
Jun 23, 2013
|
CME, IACET
|
In-Person Instruction
|
North America
|
Boston, MA, United States
|
|
#32: Understanding Translational Medicine: Benefits and Innovative Approaches
|
Jun 23, 2013
|
CME, IACET
|
In-Person Instruction
|
North America
|
Boston, MA, United States
|
|
#34: Fourteen Steps from Research to Development
|
Jun 23, 2013
|
CME, IACET
|
In-Person Instruction
|
North America
|
Boston, MA, United States
|
|
#40: Investigative Site Boot Camp: Innovative Solutions to your Operational Challenges
|
Jun 23, 2013
|
CME, IACET
|
In-Person Instruction
|
North America
|
Boston, MA, United States
|
|
#41: The DIA - HBA Skill Building Series: A Custom-Fit Leadership Approach for Women in the Regulatory, Medical, Legal and Compliance Functions
|
Jun 23, 2013
|
IACET
|
In-Person Instruction
|
North America
|
Boston, MA, United States
|
|
#35: Successful Drug Development: Best Practices for Clinical Trial Design, Agency Interactions and Regulatory Document Writing
|
Jun 23, 2013
|
IACET
|
In-Person Instruction
|
North America
|
Boston, MA, United States
|
|
Clinical Trial Disclosure Tutorial 1: A Sane Approach to Entering Results in ClinicalTrials.gov
|
Sep 30, 2013
|
IACET
|
In-Person Instruction
|
North America
|
Bethesda, MD, United States
|
|
Clinical Trial Disclosure Tutorial 2: Is Your Protocol Ready to be Published on a Public Registry
|
Sep 30, 2013
|
IACET
|
In-Person Instruction
|
North America
|
Bethesda, MD, United States
|
|
Preparing for the Physician Payment Sunshine Implementation: Research, Marketing, & Education
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Off-label Marketing Regulation in the Wake of the U.S. v. Caronia Decision
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
The Biosimilar User Fee Act: A Closer Look at the Fee Structure, Applications, and Meetings
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May 23, 2013
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|
Online Instruction
|
Global
|
Online
|
|
A Closer Look at FDASIA Provisions to Promote Biomedical Innovation
|
May 23, 2013
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|
Online Instruction
|
Global
|
Online
|
|
Assessing the Benefits and Risks of Medicines: Webinar Series - Part 1: Introduction to the Benefit-Risk - Why is Everyone Talking about Benefit-Risk?
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Assessing the Benefits and Risks of Medicines: Webinar Series Part 2 - Benefit-Risk Assessment a Changing Regulatory Landscape
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Assessing the Benefits and Risks of Medicines: Webinar Series - Part 3: Framing for Benefit-Risk Assessment and Communication
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Assessing the Benefits and Risks of Medicines: Webinar Series - Part 4: Clinical Judgment and Pragmatic Considerations for Endpoint Selection and Display in Benefit-Risk
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Assessing the Benefits and Risks of Medicines: Webinar Series- Part 5: Stated Choice Methods for Valuing Benefits and Risks
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
2 Part Series: Drug Induced Liver Injury (DILI) In-depth Look into Causality and Biomarkers Puzzle Part 1: DILI Causality: Are Current Tools & Methods Adequate? The Future of Causality
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
2 Part Series: Drug Induced Liver Injury (DILI) In-depth Look into Causality and Biomarkers Puzzle - Part 2: DILI Biomarkers: Where Are We and Where do We Need to Go?
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Taking the “Risk” Out of Risk-based Monitoring
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
DIA/FDA PDUFA V Conference - Session 7: Ensuring the Success of PDUFA V – FDA, Industry, and Stakeholder Perspectives
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Two-part Series: Impact of the New European Pharmacovigilance Legislation on International Companies
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Clinical Investigator: Module 2 - Conducting The Study
|
May 23, 2013
|
ACPE, CME
|
Online Instruction
|
North America
|
Online
|
|
Clinical Investigator: Module 1 - Study Preparation and Initiation
|
May 23, 2013
|
ACPE, CME
|
Online Instruction
|
North America
|
Online
|
|
Informed Consent
|
May 23, 2013
|
ACPE
|
Online Instruction
|
North America
|
Online
|
|
Unwrapping FDA’s UFA Package: What’s Inside the Statute – What’s Next? - Session 4 Track A: Enhanced Drug Development: Accelerated Approval, Greater Access to Experts, Pediatrics,Breakthrough Therapies, GAIN/Antibacterials
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Unwrapping FDA’s UFA Package: What’s Inside the Statute – What’s Next? - Session 3: Beyond Review Management: Additional Provisions for Regulatory Science, Enhanced Communications and Transparency
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Unwrapping FDA’s UFA Package: What’s Inside the Statute – What’s Next? - Session 5 Track B: Other Device Reforms
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Unwrapping FDA’s UFA Package: What’s Inside the Statute – What’s Next? - Session 1: PDUFA, GDUFA, and BsUFA Highlights
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Unwrapping FDA’s UFA Package: What’s Inside the Statute – What’s Next? - Session 2: MDUFA Highlights
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Unwrapping FDA’s UFA Package: What’s Inside the Statute – What’s Next? - Session 5 Track A: FDASIA Provisions to Enhance Drug Development: Drug Shortage and Supply Chain
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
DIA/FDA PDUFA V Conference - Session 3: Structured Benefit-Risk Assessment in Regulatory Decision Making, Patient-Focused Drug Development, and Advancing the Use of Patient Reported Outcome (PRO) Measures
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
DIA/FDA PDUFA V Conference - Session 4: Efficiency of Human Drug Review through Required Electronic Submissions
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
DIA/FDA PDUFA V Conference - Session 5: Regulatory Science Enhancements: Meta-Analysis, Pharmacogenomics and Biomarkers, and Rare Diseases
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
DIA/FDA PDUFA V Conference - Session 6: Standardization of Electronic Drug Application Data: A Critical Factor in Improving the Effectiveness and Efficiency of the Regulatory Review Process
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
DIA/FDA PDUFA V Conference - Session 1 - New Review Program for NME NDAs/Original BLAs and Enhanced Communication between FDA and Sponsors During Drug Development
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
DIA/FDA PDUFA V Conference - Session 2: Enhancement and Modernization of the FDA Drug Safety System in PDUFA V
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Oncology Clinical Trial Endpoints - Keys to Maximizing Success in Your Development Programs
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
BRIDG: An Information Model for Biomedical Research
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Crisis Management
|
May 23, 2013
|
ACPE, IACET
|
Online Instruction
|
North America
|
Online
|
|
Database Management
|
May 23, 2013
|
ACPE, IACET
|
Online Instruction
|
North America
|
Online
|
|
Literature Evaluation
|
May 23, 2013
|
ACPE, IACET
|
Online Instruction
|
North America
|
Online
|
|
Literature Searching
|
May 23, 2013
|
ACPE, IACET
|
Online Instruction
|
North America
|
Online
|
|
Medical Inquiries
|
May 23, 2013
|
ACPE, IACET
|
Online Instruction
|
North America
|
Online
|
|
Medical Writing
|
May 23, 2013
|
IACET
|
Online Instruction
|
North America
|
Online
|
|
Product Labeling
|
May 23, 2013
|
ACPE, IACET
|
Online Instruction
|
North America
|
Online
|
|
Regulatory Issues
|
May 23, 2013
|
ACPE, IACET
|
Online Instruction
|
North America
|
Online
|
|
Statistics for Medical Communications Professionals
|
May 23, 2013
|
ACPE, IACET
|
Online Instruction
|
North America
|
Online
|
|
Embracing Globalization within Medical Information
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Shining the Light on the Value of Customer Insights - The Unique Role of Medical Communications
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Series: The Impact of Drug Shortages on the Pharmaceutical Industry Part 1: FDA Discusses Drug Shortages: Causes, Trends, Impact and Prevention
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
The Impact of Drug Shortages on the Pharmaceutical Industry Part 4: Potential Policy Solutions to Solve Drug Shortage Problem
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
The Impact of Drug Shortages on the Pharmaceutical Industry Part 3: Coordination and Communication with FDA and Worldwide Regulatory Authorities Regarding Manufacturing and Drug Shortage Issues
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
A Tour of FDA
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
A Tour of Health Canada
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
A Tour of Health Europe
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Aspects of Regulatory History
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Bioresearch Monitoring Program (BIMO): Introduction
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
The Clinical Development Process: Investigational Product, Plan, and Data Management
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Drug Safety & Adverse Event Reporting
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Ethical Review Boards
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Ethics as the Foundation to Clinical Research
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Awareness of FDA Inspections for Pharmaceutical Manufacturers
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Biotechnology: An Overview of Compliance Considerations
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Change Control
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Clinical Trial Audits and Consequences of Non-Compliance
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Computerized Systems Inspections in the Medical Device Industry
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
European Union Clinical Trials Directive
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
GMP Principals of SOPs
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
GMP Updates - Enforcement Changes at the New FDA
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
GMPs for API Bulk Manufacturers
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Good Clinical Practices (GCPs) for New Product Investigations
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Good Laboratory Practices (GLPs)
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
GxPs
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
HIPAA - The Impact on Clinical Research
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Introduction to GMPs
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Investigational Product Development
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
ISO 14155: Obligations of Sponsors and Monitors for Medical Device Trials
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Key Concepts of Process Validation
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Laboratory Specimens for Clinical Research
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Medical Device Safety Reporting
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Orientation to GMP Compliance
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Overview of the Clinical Research Process
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Part 11: Electronic Records and Signatures - Application
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Part 11: Electronic Records; Electronic Signatures
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Principles of Good Documentation
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Protection of Human Subjects in Clinical Trials
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Selecting and Managing Clinical Contract Research Organizations (CROs)
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Understanding Post-Approval Changes
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Computerized Systems Inspections in the Pharmaceutical Industry
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Basics of the PhRMA Code
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Basics of AdvaMed Code
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Eucomed Guidelines on Interactions with Healthcare Professionals
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Introduction to Medical Device Health Care Compliance
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Foreign Corrupt Practices Act
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Global Anti-bribery
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Variations to Marketing Authorisation in Europe
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Registration of Monoclonal Antibodies
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
The ANDA: Requirements for Obtaining FDA Approval for a Generic Product in the USA
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Pharmacokinetics and Pharmacodynamics in Drug Registration
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Series: The Impact of Drug Shortages on the Pharmaceutical Industry Part 2: Drug Shortages within the Pharmaceutical Supply Chain: Impact on Patient Safety and Gray Market Control
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
CDER - Data Submission 101
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Current Initiatives in the Area of Active Pharmaceutical Ingredients (API)
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Introduction to the European Union Institutions and Regulatory Authority
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Introduction to US Institutions and Regulatory Authority (FDA)
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Introduction to Japanese Institutions and Regulatory Authorities
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Overview of the CTD and eCTD
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Introduction to the International Conference on Harmonisation (ICH)
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
The Regulatory Development of a Drug
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Basics of Pharmacovigilance
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Basics of Clinical Trials
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
How to Register Medicinal Products through the Centralized Procedure
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
How to Register Medicinal Products through the Mutual Recognition Procedure
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
How to Maintain Marketing Approvals in Europe for Centrally Authorised Products
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
How to Register a New Drug in the USA
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
How to Register Medicinal Products through the Decentralized Procedure
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Access to Unapproved Drugs through Compassionate Use
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Regulatory Requirements for the Conduct of Clinical Trials in Europe
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Orphan Drugs in the USA, European Union, and Japan
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Regulatory Requirements for the Submission of Investigational New Drug Applications in the USA (INDs)
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Meeting Opportunities with Regulatory Agencies
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Adult Oncology: Clinical Outcome Assessments (COAs) & Patient-Reported Outcomes (PROs)
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Two-part Webinar Series: Impact of the New European Pharmacovigilance Legislation and Important Updates
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|
|
Utilizing the 505(b)(2) Pathway to Streamline and Accelerate a Drug Development Plan
|
May 23, 2013
|
|
Online Instruction
|
Global
|
Online
|