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FDA Documentation

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Events

To add conferences, meetings or seminars to the list:  submit new events. 

Date

Event
Oct 03-05 Investment in Innovations (In3) East
The East Coast's largest Strategic Partnership and Investment Meeting for Medical Technology Companies
Medtech Insight/Windhover
Boston
MA
USA
Oct 05 3rd EudraVigilance Information Day
Drug Information Association
Canary Wharf
London
United Kingdom
Oct 08-12 Pharmacovigilance Training: Clinical Trials and Marketed Products
Drug Information Association
Nice
France
Oct 11-12 DIA's 4th Multitrack Workshop in Japan
Drug Information Association
Edogawa-ku
Tokyo
Japan
Oct 14-17 Successful Clinical Development From Effective Cross-Functional Teamwork-
Drug Information Association
Madrid
Spain
Oct 15-16 Advanced Clinical Statsistics for Non-Statisticians Training Course
Drug Information Association
Horsham
PA
USA
Oct 15-18 Special Training Course on US Regulatory Affairs
Drug Information Association
London
UK
Oct 15-17 Multi-Track Conference on: Successful Clinical Development from Cross-Functional Teamwork
Drug Information Association
Madrid
Spain
Oct 15-19 Computer Validation Accreditation -- Preparatory Week and Exam
CVI Accreditation answers a long-established need for a reliable method of qualifying/quantifying the experience and knowledge of Computer Validation Professionals within Pharma and related industries
Computer Validation Institute
Parsippany
NJ
USA
Oct 16-17 Medical Imaging Stakeholders Call for Action
Drug Information Association
Adelphi
MD
USA
Oct 16-17 Adverse Drug Events in Pre marketing Clinical Trials and Post marketing Pharmacovigilance
Drug Information Association
Philadelphia
PA
USA
Oct 16-17 Project Management: Team Building and Dynamics
Drug Information Association
Horsham
USA
Oct 17 Leveraging Knowledge Management
Drug Information Association
Madrid
Spain
Oct 17 Safety Data Management
Drug Information Association
Madrid
Spain
Oct 17 Operational Interfaces - From Study Planning to Report-
Drug Information Association
Madrid
Spain
Oct 17-19 International Workshop on Statistical Methodology in Clinical R&D
Drug Information Association
Madrid
Spain
Oct 17 Optimising Clinical Trial Design and Management
Drug Information Association
Madrid
Spain
Oct 18 Effective Project Management for Clinical Trials
Drug Information Association
Madrid
Spain
Oct 18-19 Medical Information & Communications
Drug Information Association
Madrid
Spain
Oct 18-19 Global Trends in Medical Writing and the Evolving Regulatory Environment
Drug Information Association
Madrid
Spain
Oct 18 Drugs in Pregnancy - From Data to Risk Communication
Drug Information Association
Madrid

Spain
Oct 18-19 Project Management: New Drug Product Development and Lifecycle Management
Drug Information Association
Horsham
PA
USA
Oct 19 INFORMATION TECHNOLOGY STRATEGIC PLANNING; PUBLIC MEETING
October 19, 2007, 9:00 a.m.
LOCATION: Advisors and Consultants Staff Conference Room, FDA, 5630 Fishers Lane, Rockville, MD 20857
CONTACT: Carolyn Yancey, Office of Chief Information Officer (HFA-80), Food and Drug Administration, 301-827-4302. The Food and Drug Administration is announcing a public meeting to solicit views and information from interested persons on issues concerning how the agency can best plan and apply information technology (IT) resources to support the process for the review of human drug applications.
Oct 22-24 Electronic Reporting of ICSRs & EudraVigilance
Drug Information Association
Horsham
PA
USA
Oct 22-24 Regulatory II: The CTD/NDA Phase Training Course
Drug Information Association
Philadelphia
PA
USA
Oct 23-25 IVT's 13th Annual International Validation Week
Achieve Validation Excellence at All Levels through More Than 30 Beginner to Advanced Presentations and Case Studies. Featuring FDA Keynote on the Risk-Based Inspection Model.
Advanstar Communications/Institute of Validation Technology
Philadelphia
PA
USA
Oct 24-26 Therapeutic Alliances
The Most Efficient Therapeutic Specific Partnering Conference for Business Development and Researchers
Windhover Information
Philadelphia
PA
USA
Oct 26 Signal Investigation: Taking Pharmacovigilance Data Mining Beyond Signal Detection
Drug Information Association
Online
USA
Oct 28-30 5th Canadian Annual Meeting: Blueprint for an Evolving Regulatory Environment
Drug Information Association
Ottawa
ON
Canada
Oct 29-30 Applied Epidemiology and Risk Management
Drug Information Association
Horsham
PA
USA
Oct 29-30 Building the eCTD
Drug Information Association
Prague
Czech Republic
Oct 29-30 GxP Computer Systems and Software Management
Auditing and Validation Strategies to meet Regulatory Compliance
IPA
Montreal
QC
Canada
Oct 30 SCIENCE BOARD TO THE FOOD AND DRUG ADMINISTRATION
October 30, 2007, 8:00 a.m.
LOCATION: Washington DC North/Gaithersburg Hilton, 620 Perry Pkwy., Gaithersburg, MD 20877, Salons A, B, and C
CONTACT: Carlos Pena, Office of the Commissioner, 301-827-6687.
The Science Board will hear about and discuss the agency's critical path program. The Science Board will hear about and discuss updates on the National Antimicrobial Resistance Monitoring System (NARMS) Program and activities related to melamine from the March 31, 2006, and June 14, 2007, Science Board meetings. The Science Board will then hear about and discuss the subcommittee review of the agency's science programs. The Science Board will also hear about and discuss the agency's updates on drug safety.
Oct 30 Part 11 & Regulatory Aspects of Computer Systems Validation (CSV)
Current FDA regulations regarding changes/FDA guidance regarding changes/FDA’s new change control concept/Elements of an effective quality system/Incorporating risk analysis into change control system
Benastrum Inc.
Online
USA-Canada
Oct 30 Using Dynamic Enrollment Management to Reduce Enrollment Cycle Time Variance
Drug Information Association
Online
USA
Nov 1-2 PDA/FDA CO-SPONSORED CONFERENCE SERIES ON QUALITY SYSTEMS
Bethesda, Maryland
CONTACT: Wanda Neal-Ballard, 301-656-5900, ext. 111, Fax: 301-962-0296.
The first conference series of its kind to focus on practical solutions for the pharmaceutical industry, the PDA/FDA Co-Sponsored Conference Series on Quality Systems will provide in depth information regarding global regulatory expectations for the management of modern quality systems, as well as strategies to prepare for related inspections. The conference will focus on the challenges faced by large, small, and virtual companies in developing and implementing robust quality systems.
Nov 02-16 Who's Monitoring the Monitor? Webinar Series
Drug Information Association
Online
USA
Nov 05 Regulatory Affairs: Part I : The IND Phase & Part II: The CTD/NDA Phase
Drug Information Association
Philadelphia
PA
USA
Nov 05-06 Clinical Statistics for NonStatisticians
Drug Information Association
Dublin
Ireland
Nov 06-08 Microbiology Event of the Year
A comprehensive, back-to-basics approach created especially for quality and microbiology professionals.
Institute of Validation Technology, a division of Advanstar Communications
San Diego
CA
USA
Nov 07-13 2007 IDDST’s Summit of Advances and Challenges towards Major Diseases
ANTI-MAJOR DISEASE IS THE RESPONSIBILITY OF ALL THE PEOPLE IN THE WORLD
Biteomics
Xi' an
Shanxi
China
Nov 12 Fundamentals of Project Management
Drug Information Association
Weston
FL
USA
Nov 12 Developing Standard Operating Procedures (SOPs)
Drug Information Association
Weston
FL
USA
Nov 12-13 Statistical Tools for GMP Compliance
Strategies and techniques on how to conduct effective statistical analysis and reporting
IPA
Toronto
ON
Canada
Nov 12-14 The Future of Pharmaceutical Project Management - Is a Paradigm Shift Needed?
Drug Information Association
Weston
FL
USA
Nov 12-15 The Leadership Experience
Drug Information Association
Phoenix
AZ
USA
Nov 13-14 DIA Outsourcing Summit
Drug Information Association
Weston
FL
USA
Nov 13-14 Publication Writing and Building Partnerships
Drug Information Association
FL
USA
Nov 13-14 Winning Strategies for Achieving a Quality EDC Clinical Trial Process
Drug Information Association
Weston
FL
USA
Nov 13-14 Clinical Trial Disclosure learning the landscape and reading the roadmap
Drug Information Association
Weston
FL
USA
Nov 13-14 The Future of Pharmaceutical Project Management: Is a Paradigm Shift
Drug Information Association
Weston
FL
USA
Nov 14 Companion to the FDA Pharmacogenomics Guidance
Drug Information Association
Online
USA
Nov 15 DIA Workshop on Paediatric Oncology
Drug Information Association
London
United Kingdom
Nov 15-16 The 6th Annual Electronic Submissions Conference eCTD: The Future Is Now
Drug Information Association
San Diego
CA
USA
Nov 18-21 DIA, ICRI, AND BCI 2nd Annual Conference on Drug Discovery and Clinical Development in India-
Drug Information Association
Powai Mumbai
India
Nov 21-22 Biomarkers in the Drug Development Process
Drug Information Association
Amsterdam
Netherlands
Nov 21-22 Photosafety Evaluation of Drugs
Drug Information Association
Amsterdam
Netherlands
Nov 26-27 European Regulatory Affairs
Drug Information Association
Paris la Defence Cedex
France
Dec 02-04 8th European Electronic Document Management Conference
Drug Information Association
Prague
Czech Republic
Dec 03-05 Pathology Visions
The premier conference on digital pathology and full slide scanning. Pathology Visions brings together experts from around the world to share best practices in digital pathology
Aperio Technologies
Amersterdam
Netherlands
Dec 03-04 2nd Cardiac Safety Conference
Drug Information Association
Prague
Czech Republic
Dec 03-04 Basics of Applied Epidemiology
Drug Information Association
Vienna
Austria
Dec 05-07 Cleanroom & Contamination Control
A Two and Half Day Course & Case Study
IPA
Toronto
ON
Canada
Dec 06-07 Future Regulatory Challenges in the Quality Area
Drug Information Association
Amsterdam
Netherlands
 
Dec 06-07 6th European Validation Workshop
Drug Information Association
Amsterdam
Netherlands
Dec 06-07 Documentation Management Strategies for GLP Compliance
Good Documentation Practices for Pharmaceutical, Biopharmaceutical Industries Ensuring Regulatory Compliance & Best Practices in GLP Operations
IPA
Toronto
Canada
Dec 10-11 PDA/FDA CO-SPONSORED CONFERENCE SERIES ON QUALITY SYSTEMS
Bethesda, Maryland
Dublin, Ireland
Beijing
Shanghai, China
CONTACT: Wanda Neal-Ballard, 301-656-5900, ext. 111, Fax: 301-962-0296.
The first conference series of its kind to focus on practical solutions for the pharmaceutical industry, the PDA/FDA Co-Sponsored Conference Series on Quality Systems will provide in depth information regarding global regulatory expectations for the management of modern quality systems, as well as strategies to prepare for related inspections. The conference will focus on the challenges faced by large, small, and virtual companies in developing and implementing robust quality systems.
Dec 10-11 Meeting the Quality Standards Bar Natural Health Products
Strategies and Updates for NHP Submissions and GMP Compliance
IPA
Toronto
ON
Canada

 

2008

Date

Event
Jan 31-
Feb 01		 11th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT
Drug Information Association
Edogawa-ku
Tokyo
Japan
Feb 05-08 21st Annual DIA Conference for Electronic Document Management
Drug Information Association
Philadelphia
PA
USA
May 26-28 Bio Venture Capital Forum
Bio Venture Capital Forum will be held at Furama Hotel Dalian China, on May 26-28, 2008. The forum is entitled as “a global platform for exploring the best bio-venture opportunities".
BITEOMICS INC
Dalian
LN
China
Apr 21-22 PDA/FDA CO-SPONSORED CONFERENCE SERIES ON QUALITY SYSTEMS
Beijing
CONTACT: Wanda Neal-Ballard, 301-656-5900, ext. 111, Fax: 301-962-0296.
The first conference series of its kind to focus on practical solutions for the pharmaceutical industry, the PDA/FDA Co-Sponsored Conference Series on Quality Systems will provide in depth information regarding global regulatory expectations for the management of modern quality systems, as well as strategies to prepare for related inspections. The conference will focus on the challenges faced by large, small, and virtual companies in developing and implementing robust quality systems.
Apr 24-25 PDA/FDA CO-SPONSORED CONFERENCE SERIES ON QUALITY SYSTEMS
Shanghai, China
CONTACT: Wanda Neal-Ballard, 301-656-5900, ext. 111, Fax: 301-962-0296.
The first conference series of its kind to focus on practical solutions for the pharmaceutical industry, the PDA/FDA Co-Sponsored Conference Series on Quality Systems will provide in depth information regarding global regulatory expectations for the management of modern quality systems, as well as strategies to prepare for related inspections. The conference will focus on the challenges faced by large, small, and virtual companies in developing and implementing robust quality systems.

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