Clinical Trials

Overview of the existing Clinical Trial Directive and an update on the future plans in the European Union
2^nd Annual Meeting of the Japanese Society of Clinical Trials and Research, Osaka, February 4-5, 2011

To what degree would improving the scope, conduct and/or efficiency of exploratory development have the potential to decrease failure rate of confirmatory studies, and potentially reduce regulatory requirements for confirmatory development?
MISG Forum on Clinical Trial Design, London, September 09, 2010

The EU Clinical Trial Directive – The Roadmap – The Way Forward
The EU Directive, 6 years on, practical implications on the set-up, conduct of trials, UCL London, November 26, 2007

Development and Implementation of Global Safety Strategies for Clinical Trials
ACT European Summit, Berlin, October 30- 31, 2007

How to handle Patient Information & Informed Consent in multinational Clinical Trials?
European Forum GCP Annual Conference, Brussels, January 31, 2007

Tutorial: Applied Pharmacoepidemiology for Investigating Safety Signals
Euro DIA Meeting, Paris, March 6-9, 2006

The Value of Active Pharmacovigilance Studies
Applied Clinical Trials European Summit 2005, Paris, October 4-6, 2005

Multicenter Trials Done in Phase I Clinical Research Units: Clinical program of a lipid lowering agent - The experience of the CRO
Annual DIA Meeting, Washington, June 26-30, 2005

Common Problems and Pitfalls and How to Avoid Them. Achieving Success in Phase III/IV Clinical Trials
ACT Winter Forum, London, November 21, 2003

 

Data Monitoring Committee

What do we need to consider for the Qualification of Data Safety Monitoring Board or Safety Advisory Board Members?
4^th Annual Clinical Forum, Lisbon, October 11-13, 2010

Data Monitoring Committees: Challenges and Recommendations
DIA Webinar, August 21, 2008

Meeting the Challenges for Data Monitoring Committees (Session Chair and Speaker) Professional Education for Clinical Researchers in Asia (Session Chair), Co-Track Chair for SIAC Professional Education & Training
Annual DIA Meeting, Atlanta, June 18-21, 2007

The Roles of Data Monitoring Committees in Safety Monitoring
2^nd Modern Drug Discovery and Development Summit, Philadelphia, December 2-4, 2006

Meeting the Challenges for Data Monitoring Committees
DIA Webinar, May 19, 2006

Meeting the Challenges for Data Monitoring Committees
Euro DIA Meeting, Paris, March 6-9, 2006

Critical Success Factors in Data Monitoring Committees (DMCs)
EUPhRMA Pharmacovigilance Working Group, London, March 3, 2005

 

Regulatory Aspects

Update on European Regulatory Trends
Pharmaceuticals and Medical Device Agency (PMDA) Japan & Tokyo University Medical Institute, October 31, 2011

Pharmacovigilance- Post-authorisation surveillance standards to meet regulatory requirements for product safety (Course Leader and Lecturer)
EUCRAF Seminar 6, Freiburg, May 19-20, 2011

How will the pharmaceutical package impact day-to-day pharmacovigilance operations?
23^rd Annual EuroMeeting, Geneva, March 28-30, 2011

Overview of the existing Clinical Trial Directive and an update on the future plans in the European Union
2^nd Annual Meeting of the Japanese Society of Clinical Trials and Research, Osaka, February 4-5, 2011

December 5, 2007 Proposal to re-design existing European drug safety rules (discussion), Track Co-Chair
Pharmaceutical regulatory and compliance congress and best practices forum, Paris, May 28-29, 2008

Public Consultation: Assessment of the Community System of Pharmacovigilance
EU Commission, Brussels, April 21 2006

Review of FDA Concept Papers on Risk Management
EU PhRMA PV Working Group, Amsterdam, August 29, 2003

Safety Relevant Legislation and Guidelines in Europe
ACRP Meeting, Prague 5-6 October, 2000

 

Risk Management

Cross Functional Working for better Results (Program Committee Member)
Drug Safety and Risk Management (Theme Co-Chair)
The Clinical Trial Approval Process (Session Chair)
How to manage Risks in Clinical Trials effectively? (Session Chair)
Risk Management in Clinical Trials – Approach and implication (Speaker)
5th Annual Clinical Forum, Basel, October 10-12, 2011

Methods for Risk Management with Examples of Risk Management Applications (Tutorial with Judith Jones)
ISOP Annual Meeting, Southampton, October 21-24, 2007

The Future of Pharmacovigilance - Safe Drug in the 21st Century (Session Chair and Talk), Tutorial: Risk Management: Turn Plans into Practice (Chair and Talk)
Euro DIA Meeting, Vienna, March 26-28, 2007

Developing a Risk Management Plan for Late Phase III or Phase IV Trials (Session Chair) Talk: Principles of Risk Management Plans in Phases III/IV
14^th Annual CRO Partnership Conference, Dallas, Texas, April 4-6, 2005

Pertinent Examples of Risk Management Strategies
IQPC Conference on Pharmaceutical Risk Management, London, September 17-18, 2003

Communication and Consequences of Your Proposed Risk Management Actions
IIR Conference on Risk Management, London, December 4, 2002

 

Safety Planning

Safety Planning for Individual Studies and Long-Term Follow Up
3^rd Annual Clinical Forum, Nice, October 19-21, 2009

How to Manage Risks during Drug Development (Session Co Chair), Practical examples (Talk) Good Pharmacovigilance: What does it mean? (Session Chair) Co-Track Chair for SIAC Professional Education & Training
Annual DIA Meeting, Washington, June 19-22, 2006

Practical Tips on Life-Cycle Risk Management Part 1: Risk Management during the Pre-Market Period
4^th Annual Conference on Risk Management, Philadelphia, October 24-26, 2005

Session: Clinical Research and Development (Chairperson), Talk: How to design a Safety Development Plan Session: Risk management – Part 1 of 3: Theory and Practice (Chairperson), Talk: Metrics and Economics of Risk Management Programs
40^th Annual DIA Meeting, Washington, June 13-17, 2004

Pragmatic ideas in drug safety monitoring pre- and post approval
DIA Annual Conference, Boston, June 7-11, 1998

 

Safety Issues

NIS - Which Design for which Research Question?
53. Klinischer Studientag: „Non-interventional Studies“, CenTrial, Stuttgart, September 22, 2011

Safety Data - Risk Management Handling and Solutions
9^th Swiss Symposium on Pharmaceutical Medicine, Bern, November 30, 2005

Safety Data – Risk Management Handling and Solutions (Session Chair) Talk: Metrics and Economics of Risk Managements Programmes
Euro DIA Meeting, Lisbon, March 7-9, 2005

Communicating safety issues effectively. The industry view.
DIA Annual Conference, Montreal, June 22-26, 1997

 

Safety Organizational Aspects

QPPV Governance/Oversight: Local vs. EU QPPV, Affiliate oversight, Patient Support Programmes
5^th European Forum for Qualified Person for Pharmacovigilance (QPPV), London, May 10-12, 2011

Differences in Managing Drug Safety Projects
Annual DIA Meeting, Boston, June 22-26, 2008

Tutorial: Drug Safety Issues: How to Set Up a Drug Safety Department
39^th DIA Annual Meeting, San Antonio, TX, June 15-19, 2003

Use of IT as a Means of Managing Adverse Events
7^th Annual Clinical Trials European Conference, Geneva, 10 April, 2000

 

Satety Reporting

Safety Reporting
4^th Annual Clinical Forum, Lisbon, October 11-13, 2010

Critical Areas For Improvement Of Commercial Clinical Trials Management: Options to Facilitate SUSAR Reporting
Euro DIA Meeting, Barcelona March, 4, 2008

The Annual Safety Report – An Efficient Tool To Communicate Safety Aspects?
Workshop 2, The EFGCF Annual Conference on „Safety in Clinical Trials – Are we in Jeopardy?“, Brussels, January 29-20, 2008

The Future of Periodic Reports. PSURs – what do they contribute to public health?
DIA Euro Meeting, Vienna, March 26-28, 2007

Insights into Reporting of Serious Adverse Events
Applied Clinical Trials, European Summit 2004, Munich, May 14, 2004

 

Signal Detection

Tutorial: How to detect and investigate safety signals
Annual DIA Meeting, Washington, June 26-30, 2005

Signal Detection During Development
Takeda Summer Forum 2005, London, June 16, 2005

Pharmacoepidemiology’s crucial role in qualifying the level of risk and determining a risk management plan: Signal Detection practices within your Pharmacovigilance plan
IIR Meeting, London, June 29-30, 2004

Tutorial: Applied Pharmacoepidemiology for Investigations of Safety Signals (Chairperson) Talk: Data Sources for Investigations
16^th Annual DIA Euro Meeting, Prague, March 9-12, 2004

Investigating Safety Signals, Tutorial; Pertinent Examples of Risk Management, Talk; Pharmacoepidemiology: An Integrative Approach to Drug Development and Life-Cycle Management” Session Chair
15^th Annual Euro DIA Meeting, Rome, March 5-7, 2003

Signal Assessment: Methodologies & Examples
ICB Conference, London, 23-24 June, 1999

Methods of Investigating Signals
DIA Seminar on Monitoring Drug Safety through the Life-Cycle of a Pharmaceutical Product, London, 15-17 February, 1999

Signals! Their identification & investigation. Methods of investigating
DIA Seminar on monitoring safety through the life-cycle of a pharmaceutical product, London, 24-28 February 1997, 23-27 February 1998, 15-17 February 1999

Quality Management

Good Clinical Practice (GCP) - Audits and Inspections
European Organisation for Research and Treatment of Cancer (EORTC) course “Organisation and Implementation of Cancer Clinical Trials”, Leuven, December 2, 2011

Quality Management for Non-interventional Studies
53. Klinischer Studientag: „Non-interventional Studies“, CenTrial, Stuttgart, September 22, 2011

Pharmacovigilance Audit and Inspection Workshop- Opportunities for Patient Safety
Joint DIA/ EFGCP Pharmacovigilance Audit and Inspection Workshop- Opportunities for Patient Safety, London, October 1, 2010

Good Pharmacovigilance Practices and their role in PV performance
15^th International Meeting of the German Society for Good Research Practice, Königswinter, September 23-24, 2010

Good Vigilance Practices- How do continuous improvement, audits and inspections contribute?
22^nd Annual EuroMeeting, Monaco, March 8-10, 2010

Drug Safety Training and Professional Education – A Perspective
Euro DIA Meeting, Berlin, March 25, 2009

How inspection ready are you? – Routine PV activities
EUPhRMA Pharmacovigilance Working Group, London, May 27, 2004

Examining Recent Introduction of Important Regulatory Guidelines and Implications They Will Have on Pharmacovigilance Work: EU Compliance Directive for Inspections, Volume 9 guidelines of Marketing Authorization Holders, Implementation of Data Privacy Act
IIR Conference on Electronic Safety Reporting, Munich, 27-28 June, 2002

Interfaces: Challenges for SOPs
Third Annual Henry Stewart Conference on “Optimizing the design and use of standard operating procedures in clinical research”. London, 7-8 December, 1998

Adverse Event SOPs
Second Annual Henry Stewart Conference on “Optimizing the design and use of standard operating procedures in clinical research”. Rockville, 8-9 October, 1998

New paths in drug safety: Global redesign
10^th International Conference on Pharmacoepidemiology, Stockholm, August 28-31, 1994

Outsourcing

Exploring the Benefits and Pitfalls of Outsourcing Pharmacovigilance Processes
SMI Conference, Reporting Adverse Events, London April 25, 2007

Risk Management Strategies from a CRO perspective
IIR Conference on Risk Management and PV strategies, London, October 19, 2004

 

Training

Drug Safety Training and Professional Education – A Perspective
21^st Annual EuroMeeting, Berlin, March 23-25, 2009

Pharmacoepidemiology
Lecturing medical students at the Mannheim Klinikum, University Heidelberg in 1999, 2000, 2001 and 2002

 

Others

Drug Safety Personnel- Qualifications? Further Education? What Are the Basic Requirements and What Is Nice to Have? Where Do Regulators and Industry Find Talent?
45^th DIA Annual Meeting, Better Medicines: Improving Safety with Every Step, San Diego, June 21-25, 2009

Pharmacovigilance: Interactive co-ordination & dissemination
16^th ESRA International Meeting on roles and responsibilities of registration groups in the future: local vs. headquarters. Brussels, February 23, 1995

Plasma fibrinogen: A predictor of coronary heart disease?
Epidemiology Workshop, Berlin, March 15-16, 1993

 

Pietrek M. & Bendall C. Pharmacovigilance Terminology and the new EU Pharmacovigilance Legislation. Global Forum. December 2011; 3 (6): 10-17.

Pietrek M. How to Train your Staff for Pharmacovigilance Inspection Readiness in the EU. Quasar. July 2011; 21-27.

Pietrek, M. Background on the Assessment of a Drug-event Relationship. Global Forum. 2010; 2 (6): 64-66.

Pietrek M., Coulson R., Czarnecki A. Good Pharmacovigilance Practice – The Way Forward? Drug Information Journal. 2009; 43 (5): 623-632.

Pietrek M. How to become PV inspection ready? DIA Forum. March 2006.

Wood L. & Coulson R. Revitalizing the General Research Database: plans, challenges and opportunities. Pharmacoepidemiology and Drug Safety. 2001; 10: 379-383.

Pietrek M. The safety and tolerability of candesartan cilexetil in CHF. Journal of Renin-Angiotensin-Aldosterone System. 2000; 1 (Suppl. 1): 31-36.

Pietrek M. The cardiovascular mortality and morbidity of Candesartan in CHF. (abstract) Journal of Heart Failure. 2000; 6 (1): 8.

Grant E.M., Coulson R.A. & Wood S.M. ADROIT and AEGIS: An IT Solution to the Challenge of Drug Safety Monitoring. In: Electronic Communication Technologies – techniques and technologies for the 21st Century. Mitchard M. (Ed.) Buffalo Grove (IL): Interpharm Press Inc. 1998; 28: 551-574.

Montero D., De Abajo F., Coulson R., Biron A., Ceinos C., Zinnhobler K.H., & Moore N.  The EuroSCaPE Project. Electronic Communication Technologies - techniques and technologies for the 21st Century. Mitchard M. (Ed.) Buffalo Grove (IL): Interpharm Press Inc. 1998; 26: 517-526.

Waller P.C., Coulson R.A. & Wood S.M. Regulatory Pharmacovigilance in the United Kingdom: Current Principles and Practice. Pharmacoepidmiology and Drug Safety. 1996; Vol 5: 363-375.

Pietrek M. Pharmacovigilance: Interactive co-ordination & dissemination. ESRA Rapporteur. 1995; 2 (6): 13-15.

Wood K.L., Coulson R.A. & Wood S.M. MedDRA: the basis for the new international medical terminology for regulatory purposes. European Society of Regulatory Affairs Rapporteur. 1995; 2: 12-15.

Wood S.M., Coulson R. & Eccles S. Signal Generation in the UK. European Medicines Research, G.N. Fracchia (Ed.), IOS Press. 1994; 360-363.

Moore N., Montero D., Coulson R., De Abajo F., Kreft-Jais C., Biron A. & Palop R. Communication in Pharmacovigilance. Pharmacovigilance and Drug Safety. 1994; 3: 151-155.

Moore N., Montero D., Coulson R., De Abajo F., Kreft-Jais C., Biron A. & Monteagudo J.L. The Single Case Format: Proposal for a Structured Message for the Telematic Transmission of Information on Individual Case Reports. Pharmacovigilance and Drug Safety. 1994; 3: 157-162.

Montero D., Moore N., Coulson R., Zabala J.L., De Abajo F., Kreft-Jais C., Wigglesworth K., Biron A. & Monteagudo J.L. Electronic Transmission of Rapid Alerts in Pharmacovigilance: a Pilot EC Experiment. Pharmacoepidmiology and Drug Safety. 1994; 3: 163-167.

Binns A., Wood S. & Coulson R. Electronic Information Exchange between the Pharmaceutical Industry and a Regulatory Authority. Pharmacoepidemiology and Drug Safety. 1994; Vol 3. Supp 1. S67.

Pietrek M. Definitions of adverse drug reactions and minimum requirements for their use - cardio-vascular terms. Pharmacoepidemiology and Drug Safety. 1993; 2: 591-602.

Pietrek M. Basic requirements for the use of terms for reporting adverse drug reactions (V). Pharmacoepidemiology and Drug Safety. 1993; 2: 189-193.

Mouritzen C, Drömer M (née: Pietrek), Keinecke H O. The effect of fibrin glueing to seal bronchial and alveolar leakages after pulmonary resections and decortications. European Journal of Cardio-Thoracic Surgery. 1993; 7: 75-80.

Wood S.M. & Coulson R. Adverse Drug Reactions On-line Information Tracking (ADROIT). Pharmaceutical Medicine. 1993; 7: 203-213.

Bem J.L., Mann R.D. & Coulson R. Fatal Gastrointestinal Damage Associated with the Use of Osmotic Mini Pump Indomethacin (Osmosin). Pharmaceutical Medicine. 1988; 3(1): 35-43.