Calendar of Events. 1 2 June 2006 RAPS 2006 European Conference: EU Regulatory Response to Innovation and Global Competitiveness

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1 Calendar of Events 31 May 2 June 2006 The Validation Manager Venue: Vienna, Austria. 1 2 June 2006 RAPS 2006 European Conference: EU Regulatory Response to Innovation and Global Competitiveness Venue: Lisbon, Portugal. 1 2 June 2006 Adverse Events: Managing and Reporting for Pharmaceuticals 1 2 June 2006 Clinical Trials for Pharmaceuticals: Design and Development 2 June 2006 JSQA Annual Meeting Venue: Tokyo, Japan. Please contact: JSQA, June 2006 Good Clinical Practices 5 June 2006 GLP for Facility Management 5 June 2006 Ethics and GCP Forum Venue: Marlow, UK. Please contact: Institute of Clinical Research, June 2006 Statistics 101: An Introduction to Statistical Principles and Thinking in Drug Development Please contact: PERI, June 2006 Statistical Concepts for Non-Statisticians 5 7 June 2006 The Auditing Course 6 9 June 2006 Training Course on Quality Management in Pharma and Biotech (Module 2/4) Venue: Halle-Zoersel, Belgium. Please contact: EUFEPS, 7 June 2006 RAPS Regulatory Update Webcast: Japan Drugs 7 9 June 2006 Essential Training Course for New Clinical Statisticians Please contact: PERI, June 2006 Adverse Events: Managing and Reporting for Medical Devices Global GCP Monitoring DOI: /qaj.367

2 148 Calendar of Events Conducting Clinical Trials under ICH GCP Conducting Clinical in Developing Regions Auditing Techniques for Clinical Research Professionals Writing for Clinical Research Validation of Analytical Test Procedures, Basic Seminar with Workshops Venue: Prague, Czech Republic June 2006 Computer Systems Validation Masterclass Venue: Barcelona, Spain June 2006 Regulatory Compliance and Computer Systems June 2006 Comprehensive Monitoring for Medical Devices June 2006 Promoting & Managing Change in a Regulated Environment Venue: Ipswich, UK June European Pharma IT Compliance Week Venue: Cork, Ireland. 13 June 2006 Interactive Web Seminar: Developing and Negotiating Study Budgets June 2006 Clinical Trials for Medical Devices: Design and Development 14 June 2006 RAPS Overview of Drugs & Biologics (US) Webcast June 2006 Fundamentals/1st Steps of Clinical Research Venue: Las Vegas, NV, USA. Monitoring Clinical Drug Studies: Intermediate Effective Clinical Report Writing

3 Calendar of Events 149 Introduction to Clinical Project Management Pharmacokinetics June nd DIA Annual Meeting Please contact: DIA, June 2006 Drug Development and FDA Regulations June 2006 Clinical Project Management: Intermediate June 2006 Process Mapping as a Management and Auditing Tool June 2006 Standard Operating Procedures (SOPs) in Clinical Research 21 June 2006 RAPS Overview of Medical Devices (US) Webcast June 2006 Monitoring Clinical Drug Studies: Beginner June 2006 International Congress on Analytical Sciences (ICAS-2006) Venue: Moscow, Russia. Please contact: CITAC, June 2006 Introduction to Clinical Data Management June 2006 GLP for Study Directors, Principal Investigators, Study Staff and Management 28 June 2006 RAPS Webcast: Overview of Labeling, Advertising/Promotion, Compliance & Enforcement (US) June 2006 The CRA Manager Course 30 June 2006 Interactive Web Seminar: Examine Approaches for Investigator Initiated Trials 4 July 2006 Introduction to Good Clinical Practice in Clinical Research Venue: Marlow, UK. Please contact: Institute of Clinical Research,

4 150 Calendar of Events 4 5 July th Annual Symposium Best Practice at the GMP/GCP Interface 5 July 2006 RAPS Regulatory Update Webcast: EU Medical Devices July 2006 Development Strategies and Clinical Trial Methods for Oncologic Products Please contact: PERI, 12 July 2006 RAPS Combination Products Webcast: FDA Regulation of Combination Products 17 July 2006 Achieving and Maintaining 21 CFR Part 11 Compliance July 2006 Computer System Validation in FDA-regulated Industries 19 July 2006 RAPS Combination Products Webcast: Key Issues for a Combination Product s Lifecycle 20 July 2006 Risk Management Applied to Computer System Validation July 2006 Standard Operating Procedures Workshop for Senior Site Managers Venue: Toronto, Ontario, Canada. 21 July 2006 Auditing Computer System Providers 2 August 2006 RAPS Regulatory Update Webcast: Clinical Trials 7 August 2006 Overview of Drug Development Venue: Princeton, NJ, USA. 7 9 August 2006 Fundamentals of Clinical Research Monitoring 17 August 2006 The Basics of Regulatory Affairs August 2006 Advanced Topics in Clinical Research/Drug Development August 2006 European Regulatory Affairs 3 6 September th International Conference on Pharmaceutical Medicine Venue: Seoul, South Korea. Please contact: IFAPP,

5 Calendar of Events September 2006 RAPS Regulatory Update Webcast: US Biologics 8 9 September 2006 Fundamentals/1st Steps of Clinical Research 9 September 2006 SOPs for Investigator Sites September 2006 Pre-conference GCP Training Day & ACRP European Conference Venue: Brussels, Belgium September 2006 TOPRA CRED Workshop: European Regulatory Procedures Venue: Amsterdam, Netherlands. 15 September 2006 Developing Standard Operating Procedures September th World Congress of Biomedical Laboratory Science (2006 IFBLS World Congress) Venue: Seoul, South Korea. Please contact: IFBLS, September 2006 Clinical Statistics for Non-Statisticians Venue: Baltimore, MD, USA September 2006 Drug Safety Surveillance and Epidemiology September 2006 SoCRA Annual Conference September 2006 Introduction to Good Clinical Practices and Auditing September 2006 Training Course on Quality Management in Pharma and Biotech (Module 3/4) Venue: Nijmegen/Berg en Dal, Netherlands. Please contact: EUFEPS, September 2006 SQA 2006 Fall Training Please contact: SQA, September European Pharma IT Compliance Week 26 September 2006 Computer System Validation Venue: Feasterville, PA, USA September th International Workshop on Pediatric Clinical Trials Venue: Toronto, Ontario, Canada September 2006 DGGF Annual Meeting Venue: Darmstadt, Germany. Please contact: DGGF, October 2006 TOPRA 3rd Annual Symposium Venue: Amsterdam, Netherlands.

6 152 Calendar of Events 4 October 2006 RAPS Regulatory Update Webcast: EU Medicinal Products 4 5 October rd Joint SARQA/DKG Conference: Current Status and Quality in Research and Development Venue: Copenhagen, Denmark. Please contact: SARQA, or DKG, October 2006 Statistical Methodology in Clinical R&D Venue: Heidelberg, Germany. 4 6 October 2006 Practical GCP Compliance Auditing of Trials & Systems 12 October 2006 The Basics of Regulatory Affairs October 2006 Clinical Research Monitoring Workshop Venue: Denver, CO, USA October 2006 RAPS 2006 Annual Conference & Exhibition Venue: Baltimore, MD, USA. 17 October 2006 Successful Strategies for Medical Device Trials Venue: Minneapolis, MN, USA. 18 October 2006 FDA and the Clinical Investigator October 2006 Microbiology for Non-Microbiologists, Understanding the True Meaning of Microbiological Finding Venue: Berlin, Germany October 2006 Fundamentals/1st Steps of Clinical Research Venue: Houston, TX, USA October 2006 Project Management Venue: Alexandria, VA, USA October 2006 Advanced Clinical Statistics for Nonstatisticians October 2006 Training Course on Quality Management in Pharma and Biotech (Module 4/4) Venue: Delft, Netherlands. Please contact: EUFEPS, October 2006 Special Training Course on US Regulatory Affairs Venue: Amsterdam, Netherlands October 2006 Essential SOPs, Required Documentation and Regulatory Requirements for Clinical Research 30 October 2006 Development of a Clinical Study Report

7 Calendar of Events November 2006 RAPS Regulatory Update Webcast: Device Postmarket Issues Medical November 2006 FDA Clinical Trial Requirements Regulations, Compliance and GCP Venue: Indianapolis, IN, USA. 3 4 November 2006 Good Clinical Practices Venue: Alexandria, VA, USA. 6 November 2006 Performing Pediatric Trials Venue: Atlanta, GA, USA November 2006 FDA and GMP Compliance in Quality Assurance Units Venue: Prague, Czech Republic. 9 November 2006 TOPRA CRED Workshop: Clinical Trials Outside Europe November 2006 DIA 7th Middle East Regulatory Conference (MERC) Venue: Dubai, United Arab Emirates. 15 November 2006 RAPS Good Laboratory Practices (GLP) Webcast: Module 1 22 November 2006 RAPS Good Laboratory Practices (GLP) Webcast: Module 2 30 November 1 December European Software Validation Workshop 6 December 2006 RAPS Regulatory Update Webcast: Drug Postmarket Issues 13 December 2006 RAPS Risk Management Webcast 29 April-3 May rd SQA Annual Meeting Venue: Austin, TX, USA. Please contact: SQA, Prepared by Katy Sotirov