The Management of Clinical Trials - GMP meets GCP

This seminar discusses a variety of topics related to IMP supplies and clinical trial management - always with a focus on the interface between GMP and GCP. Case studies and workshops make the seminar a hands-on experience for all participants.

Further details will become available at:
www.gmp-compliance.org

Qualitätssicherung in der klinischen Forschung / Quality Assurance in Clinical Research

Quality assurance (QA) activities in clinical research are indispensable. Key QA tasks and activities are presented during the seminar, trial-specific and systems audits are outlined and the scope of the most frequent audit types is detailed.

Further information will be made available at:
www.forum-institut.de

4th Annual Clinical Trial Logistics Conference

The conference addresses Investigational Medicinal Product (IMP) logistics from planning to destruction. Rita Hattemer-Apostel has been invited to host a workshop on GCP requirements related to IMPs and weaknesses and deficiencies observed at investigator sites with regard to IMP.

Further information will be available at:
www.smi-online.co.uk

SPAQA Annual Meeting 2010

Rita Hattemer-Apostel contributes to the meeting with a presentation on 'Experiences with GCP Mock Inspections' and will share observations made during preparation, conduct and follow-up of mock inspections at investigator sites and sponsors. Real-life experience - as close to a real inspection as it can get.

Further information will be available at:
www.spaqa.org

26th SQA Annual Meeting - Building Bridges to Compliance

The meeting will bring together GCP, GLP and GMP Quality Assurance experts from around the globe, providing an opportunity to hear about regulatory updates, new ideas and trends in QA and simply to network. We will contribute with a presentation titled "GCP Mock Inspections: Real Experiences of a Fake Inspector".

Further information is available at:
www.sqa.org

8. Symposium - GCP-konforme Archivierung von Unterlagen aus klinischen Prüfungen / 8th Symposium - GCP-compliant Archiving of Clinical Trial Documents

Essential documents (chapter 8 of ICH GCP) must be archived for a suffiently long period so that inspectors and auditors can access the data. Archiving requirements are stipulated in a variety of documents, international as well as domestic, for investigators, sponsors and existing/potential marketing application holders. The symposium sheds light on the requirements and provide practical insight into this matter.

Details will become available at:
www.centrial.de

2. Erlanger Fachtagung für Studienassistentinnen & Studienassistenten / 2nd Erlanger Seminar for Study Assistants

We have been invited to contribute presentations on 'GCP Inspections - An Auditor's Perspective' and 'FDA Requirements and Expectations'.

Further information will be made available at:
www.akademie.uk-erlangen.de

Quality Assurance in Clinical Research

Quality assurance (QA) activities in clinical research are indispensable. Key QA tasks and activities are presented during the seminar, trial-specific and systems audits are outlined and the scope of the most frequent audit types is detailed.

Information will become available at:
www.forum-institut.de

GCP Training: Update on Regulatory Requirements and Trends and Results from GCP Inspections

Course at Client Site

GCP Inspections by Regulatory Authorities

Course at Client Site

Trial Master File according EudraLex Vol. 10; Supply and Study Management; Suspected Misconduct and Fraud in Clinical Trials

Presentations at "The Management of Clinical Trials - GMP meets GCP", Education Course, organized by the European Compliance Academy

Qualitätssicherung in der klinischen Forschung / Quality Assurance in Clinical Research

Co-Chair and Presentations, Seminar, organized by Forum Institut für Management

3. KKSN-Symposium: Head-to-Head Studien

Session Chair at the Symposium

Regulatory Requirements for Data Management and Statistics; Quality Assurance Issues in Data Management and Statistics

Presentations at "Clinical Data Management und Auswertephase: valide Daten in klinischen Studien", Seminar, organized by BPI/Colloquium Pharmaceuticum

GCP Inspection by Regulatory Authorities

Course at Client Site

Clinical Trials Under Scrutiny: How to Improve Inspection Readiness

Presentation at the Clinical Trial Innovation Summit

SPAQA Annual Conference - 20th Anniversary: Looking Back and Forth

Chair of the Conference

Adaptive Auditing ... And More New Skills for Auditors

Presentation at the 25th SQA Annual Meeting

GCP Inspections by Regulatory Authorities: preparation, management, follow-úp, review of typical inspection findings and a program for inspection readiness

Course at Client Site

GCP Audits & Inspektionen / GCP Audits and Inspections

Co-Chair and Presentations, Seminar, organized by Forum Institut für Management

GCP Training

Course at Client Site

Trial Master File according EudraLex Vol. 10; Supply and Study Management; Suspected Misconduct and Fraud in Clinical Trials

Presentations at "The Management of Clinical Trials - GMP meets GCP", Education Course, organized by the European Compliance Academy

Beyond the Audit

Presentation and participation in the Senior Management Strategy Goup at the 2nd Global Quality Assurance Conference

GCP Training

Course at Client Site

CRF and Source Data; Data Validation and Quality Assurance

Presentations at "Clinical Data Management und Auswertephase: valide Daten in klinischen Studien", Seminar, organized by BPI/Colloquium Pharmaceuticum

Thoughts on the Future of QA

Presentation at the 13th DGGF Annual Meeting

Quality - At Any Cost?

Presentation at the 15th International Conference on Pharmaceutical Medicine (ICPM 2008)

GCP Training

Course at Client Site

GCP Training

Course at Client Site

Compliance Problems Identified In Ethical Review: An Analysis Of US FDA Warning Letters And Reflection On Audit Experiences In Europe

Presentation at the 24th SQA Annual Meeting

You Can’t Always Get What You Want – Some Critical Comments On Systems Audits

Presentation at the 24th SQA Annual Meeting

SPAQA Annual Conference: Quality Beyond Boundaries

Chair of the Conference

GCP Training

Course at Client Site

GCP Training

Course at Client Site

GCP Training

Course at Client Site

GCP Training

Course at Client Site

GCP Training

Course at Client Site

GCP-Inspektionen von FDA, EMEA und nationalen Inspektoraten / GCP Inspections by FDA, EMEA and Domestic Inspectorates

Co-Chair and Presentations, Seminar, organized by Forum Institut für Management

Trial Master File according EudraLex Vol. 10; Supply and Study Management; Suspected Misconduct and Fraud in Clinical Trials

Presentations at "The Management of Clinical Trials - GMP meets GCP", Education Course, organized by the European Compliance Academy

SPAQA Regulatory Round Table

Chair of the Regulatory RoundTable

Quality Management and Regulatory Requirements in Drug Development

Presentation at "Critical Steps in Drug Development Programs: From Lead Candidate Selection to Preclinical Studies and Successful Clinical Trials Phase II", seminar, organized by the Swiss Biotech Association

CRF and Source Data; Data Validation and Quality Assurance

Presentations at "Clinical Data Management und Auswertephase: valide Daten in klinischen Studien", Seminar, organized by BPI/Colloquium Pharmaceuticum

Monitoring von klinischen Versuchen bei Pharmazeutika / Monitoring of Clinical Trials in Pharmaceuticals

Co-Chair and Presentations, Seminar, organized by Forum Institut für Management

GCP Training Modules (Overview on Drug Development; Regulatory and Ethical Basis for Conducting Clinical Research; Pitfalls in Clinical Trials; Quality Principles in Reserach and Development)

Training at Client Site

Deficiencies in Ethics Committee Review in Clinical Research: An Analysis of FDA Warning Letters to Institutional Review Boards (IRBs)

Presentation at the 21st EACME (European Association of Centres of Medical Ethics) Annual Conference "Bioethics in the Real World"

GLP and GCP in the Laboratory - Regulatory Requirements and Practical Consequences

Course at Client Site (together with isomehr GmbH)

Quality of Pharmacokinetic Data - Learning from Experience

Presentation at the 23rd SQA Annual Meeting

The Role, Opportunities and Limitations of Auditing - A Critical Reflection in the Context of Quality Management, Risk Management and Knowledge Management

Presentation at the 23rd SQA Annual Meeting

Effective Technical Writing for Publications

Presentation at the pre-conference training on "Introduction to Effective Technical Communication Tools for the QA Profession" at the 23rd SQA Annual Meeting

SPAQA Annual Conference: QA - Broadening the Quality Horizon

Chair of the Conference

Die Fachassistenz in der klinischen Forschung - Aufgaben und Verantwortung bei klinischen Versuchen / Assistants in Clinical Research - Tasks and Responsibilities in Clinical Trials

Seminar, organized by Forum Institut für Management

GCP-Inspektionen von FDA, EMEA und nationalen Inspektoraten / GCP Inspections by FDA, EMEA and Domestic Inspectorates

Co-Chair and Presentations, Seminar, organized by Forum Institut für Management

Core Documents in Clinical Trials - Purpose, Contents and Points to Consider: IB - Protocol - CRF - Informed Consent - Report

Presentation at the "Good Clinical Practice Workshop 2006", organized by the DC-THERA – Dendritic Cells & New Immunotherapies Network of Excellence

From Source Data to Clean Data - Managing Data in Clinical Trials: An Overview on GCP Requirements for Data Management and Statistics

Presentation at the "Good Clinical Practice Workshop 2006", organized by the DC-THERA – Dendritic Cells & New Immunotherapies Network of Excellence

What Does Go Wrong in Early Phase Clinical Trials? Audit Observations, Case Studies and Insights

Presentation at the "Good Clinical Practice Workshop 2006", organized by the DC-THERA – Dendritic Cells & New Immunotherapies Network of Excellence

SPAQA GLP Regulatory RoundTable

Chair of the Regulatory RoundTable

International Regulations and Standards in Clinical Research/GCP

Presentation at "Klinische Versuche in der Schweiz / Conducting Clinical Trials in Switzerland", organized by Forum Institut für Management

Conducting Clinical Trials: Practical Tips and Points to Ponder

Presentation at "Klinische Versuche in der Schweiz / Conducting Clinical Trials in Switzerland", organized by Forum Institut für Management

Monitoring von klinischen Versuchen bei Pharmazeutika / Monitoring of Clinical Trials in Pharmaceuticals

Co-Chair and Presentations, Seminar, organized by Forum Institut für Management

CRF and Source Data; Data Validation and Quality Assurance

Presentations at "Clinical Data Management und Auswertephase: valide Daten in klinischen Studien", Seminar, organized by BPI/Colloquium Pharmaceuticum

Set-Up of Clinical Trials - Documentation and Organizational Requirements

Course at Client Site

Good Clinical Practice - Overview on Regulatory Requirements, Responsibilities and Inspections

Presentation at the "Good Manufacturing Practice Workshop 2006", organized by the DC-THERA – Dendritic Cells & New Immunotherapies Network of Excellence

Comparison of Approaches to Quality in GCP, GLP and GMP

Invited presentation at the 15th Annual Meeting of the Japan Society of Quality Assurance (JSQA)

SPAQA Annual Conference: QA - Get Ready for the Future!

Chair of the Conference

Qualitätsmanagement in der Arzneimittelforschung: Prinzipien, Paradigmen und Perspektiven / Quality Management in Pharmaceutical Research: Principles, Paradigms and Perspectives

Lecture at the university course on "Collaboration in Healthcare", module "Quality Management and Quality Assurance in Healthcare, with emphasis on drug research", offered and organized by the University of Berne

Change of the European Regulatory Landscape: (How) Does it Affect QA?

Presentation and chair of session "Conducting Clinical Trials in the European Union: Regulatory Developments and Impact on Quality Assurance" at the 22nd SQA Annual Meeting

Conducting Phase I Trials: Specifics, Regulations and Audit Experiences

Presentation at "Discovery Summit 2006", organized by marcus evans summits

Ethical Basis and Regulatory Requirements for the Conduct of Clinical Trials

Course at Client Site

Qualitätssicherung in der klinischen Forschung / Quality Assurance in Clinical Trials

Co-Chair and Presentations, Seminar, organized by Forum Institut für Management

International Regulations and Standards in Clinical Research/GCP

Presentation at "Klinische Versuche in der Schweiz / Conducting Clinical Trials in Switzerland", organized by Forum Institut für Management

Conducting Clinical Trials: Practical Tips and Points to Ponder

Presentation at "Klinische Versuche in der Schweiz / Conducting Clinical Trials in Switzerland", organized by Forum Institut für Management

GCP-Inspektionen von FDA, EMEA und nationalen Inspektoraten / GCP Inspections by FDA, EMEA and Domestic Inspectorates

Co-Chair and Presentations, Seminar, organized by Forum Institut für Management

Monitoring von klinischen Versuchen / Monitoring of Clinical Trials

Co-Chair and Presentations, Seminar, organized by Forum Institut für Management

SPAQA GLP Regulatory RoundTable

Chair of the Regulatory RoundTable

GCP in Clinical Drug Development: Quality & Ethics

Presentation at "Quality Management: Quicker Approvals Through Compliance", the first joint networking event organized by the Swiss Biotech Organization (SBA) and the Swiss Professional Association of Quality Assurance (SPAQA)

Approaches to Quality in R&D: Shifting Paradigms

Presentation at "Evolution Summit 2005 - Best Practices in European Drug Development", organized by marcus evans summits

CRF and Source Data; Data Validation and Quality Assurance

Presentations at "Clinical Data Management und Auswertephase: valide Daten in klinischen Studien", Seminar, organized by BPI/Colloquium Pharmaceuticum

Ethics in Biomedical Research

Course at Client Site

Quality Management/Quality Assurance in Clinical Trials

Course at Client Site

Qualitätssicherung im GCP-Bereich: "work smarter, not harder!"

Course with Workshops, organized by PFC Pharma Focus Ltd.

SPAQA Annual Conference: Quality in Motion

Chair of the Conference

GCP Compliance bei der Durchführung klinischer Studien - GCP für Fortgeschrittene / Conducting GCP-compliant Clinical Trials - Advanced GCP Course

Seminar, organized by IIR/Pharmaceutical Training Institute

GCP Training and Update on Inspections (FDA/EU) (tailored to the particular requirements of a complex, multinational trial)

Course at Client Site

From Mouse to Man: Problem Areas from Preclinical to Clinical Development

Presentation and chair of session "Challenges and Observations of Auditing Phase I/II Trials" at the 1st Global Quality Assurance Conference and 21st SQA Annual Meeting

Ideas on Auditing Data Management and Statistics

Presentation and chair of session "Conducting Audits in Data Management and Statistics - Beyond Looking at Databases" at the 1st Global Quality Assurance Conference and 21st SQA Annual Meeting

Leveraging the Value and Impact of Quality Assurance

Presentation in session "Is QA Being Taken Seriously? - Thoughts on How to Raise Respect for QA" at the 1st Global Quality Assurance Conference and 21st SQA Annual Meeting

Good Clinical Practice in Europe

Presentation at the Pre-Conference Training 'Advanced Topics in GCP: A Global GCP QA Workshop and Seminar' at the 1st Global Quality Assurance Conference and 21st SQA Annual Meeting

The Changing Role of Quality Management

Chair of the R&D Stream and Closing Keynote Presentation at "PHARMtechexpo", organized by marcus evans congresses

SOP Training

Course at Client Site

SOP Training

Course at Client Site

SOP Training

Course at Client Site

Monitoring von klinischen Versuchen / Monitoring of Clinical Trials

Co-Chair and Presentations, Seminar, organized by Forum Institut für Management

GCP Compliance bei der Durchführung klinischer Studien - GCP für Fortgeschrittene / Conducting GCP-compliant Clinical Trials - Advanced GCP Course

Seminar, organized by IIR/Pharmaceutical Training Institute

SPAQA GLP Regulatory RoundTable

Chair of the Regulatory RoundTable

Data Management, Data Validation und Abklärungsprozedur/DCF

Presentation at "Data Management und Auswertephase: valide Daten in klinischen Studien - die Schnittstelle zwischen Monitoring und Auswertung", Seminar, organized by BPI/Colloquium Pharmaceuticum

The Changing Role of Quality Management

Presentation at "Evolution Summit 2004 - Best Practices in Drug Development", organized by marcus evans summits

Implementation of the EU Clinial Trials Directive - A European Dramedy

Course at Client Site

FDA IND Requirements for the Conduct of Clinical Trials

Course at Client Site

GCP und Qualitätssicherung

Presentation at "12. AMG-Novelle - Praktische Umsetzung der Anforderungen des novellierten Arzneimittelgesetzes", Symposium organized by PAED-Net/KKS Mainz/KKS Heidelberg

Set-Up of Clinical Trials - Documentation and Organizational Requirements

Course and Workshop at Client Site

ICH and GCP Requirements for Data Management/Biostatistics

Course at Client Site

Swiss Regulatory System: News from Switzerland and SPAQA

Presentation at BARQA International Meeting

Big Picture Auditing: Finding a Way Out of the Check Box and into Effective and Efficient Quality Management

Presentation and chair of session "It is Time to Rename QA - Novel Approaches to GCP QA" at the 20th SQA Annual Meeting

QA's New Role - Wish or Vision?

Presentation and chair of session "It is Time to Rename QA - Novel Approaches to GCP QA" at the 20th SQA Annual Meeting

SPAQA Annual Conference: SPass An QA - Enjoy QA

Chair of the Conference

FDA IND Requirements for the Conduct of Clinical Trials

Course at Client Site

SOP Training

Course at Client Site

Quality Management/Quality Assurance in Clinical Trials

Course at Client Site

SOP Training

Course at Client Site

GCP-Compliance bei der Durchführung klinischer Studien - GCP für Fortgeschrittene

Seminar, organized by IIR/Pharmaceutical Training Institute

Ethical Basis and Regulatory Requirements for the Conduct of Clinical Trials

Course and Workshop at Client Site

Quality Issues and Audit Findings in Phase I/II Studies

Presentation at "DC.N RoundTable: Von der Präklinik zur Phase II - Innovative Lösungen", organized by DrugConsult.Net

SOP Training

Course at Client Site

SOP Training

Course at Client Site

SOP Training

Course at Client Site

Data Management, Data Validation und Abklärungsprozedur

Presentation at "Data Management und Auswertephase valider Daten in klinischen Studien: die Schnittstelle zwischen Monitoring und Auswertung", Seminar, organized by BPI/Colloquium Pharmaceuticum

Monitoring von klinischen Versuchen/Monitoring of Clinical Trials

Co-Chair and Presentations, Seminar, organized by Forum Institut für Management

GCP-Compliance bei der Durchführung klinischer Studien - GCP für Fortgeschrittene

Seminar, organized by IIR/Pharmaceutical Training Institute

SPAQA GLP Regulatory RoundTable

Chair of the Regulatory RoundTable

Qualitätssicherung in der klinischen Forschung/Quality Assurance in Clinical Trials

Co-Chair and Presentations, Seminar, organized by Forum Institut für Management

SOP Training

Course at Client Site

European Clinical Studies - Logistics and Problems for the QA Professional

Presentation in session "An Overview of the International Clinical Trial Scene" at the 19th SQA Annual Meeting

SOP Training

Course at Client Site

SOP Training

Course at Client Site

GCP-Compliance bei der Durchführung klinischer Studien - GCP für Fortgeschrittene

Seminar, organized by IIR/Pharmaceutical Training Institute

Data Management, Data Validation und Abklärungsprozedur

Presentation at "Data Management und Auswertephase valider Daten in klinischen Studien: die Schnittstelle zwischen Monitoring und Auswertung", Seminar, organized by BPI/Colloquium Pharmaceuticum

GCP Non-Compliance - Benefits and Limits of Auditing

Presentation at SPAQA Annual Meeting

Good Practice in Drug Development

Co-Chair and Presentations, GCP/GLP/GMP-Seminar, organized by Verdandi AG and isomehr GmbH

GCP-gerechte Durchführung klinischer Studien

Couse and Workshop at Client Site

ICH Good Clinical Practice: Review of Key Aspects

Presentation at Client Site

Quality Management in Clinical Research: Quality Control, Quality Assurance and Standard Operating Procedures

Presentation at Client Site

FDA IND Requirements for Clinical Trials

Presentation and Workshop, organized by Client

Big Q in Clinical Research: QM, QA, QC, SOPs and more

Presentation and Workshop, organized by Client

Qualitätssicherung in der klinischen Forschung/Quality Assurance in Clinical Trials

Co-Chair and Presentations, Seminar, organized by Forum Institut für Management

Set-Up of Clinical Trials - Documentation and Organizational Requirements

Course and Workshop at Client Site

Standard Operating Procedures - Regulatory Background & Key Aspects

Presentation and Workshop, organized by Client

European Union Data Protection Directive: Current Status and Impact on Data Transfers

Presentation in session "Clinical Research Considerations with 21 CFR Part 11 - Technology, Suppliers and Patient Privacy" at the 18th SQA Annual Meeting

Ethical Basis and Regulatory Requirements for the Conduct of Clinical Trials

Course and Workshop at Client Site

Fraud and Misconduct in Clinical Research

Presentation and Workshop, organized by Client

Dynamic Simulation Methodology as a Tool for Enhancing Process Management

Presentation in session "Fit for Future Challenges: Sustained GCP Compliance with Increased Flexibility" at the 38th DIA Annual Meeting

Sustained Compliance through (GCP)2: 'Generating Compliant Processes' Means 'Good Clinical Practice'

Presentation and chair of session "Fit for Future Challenges: Sustained GCP Compliance with Increased Flexibility" at the 38th DIA Annual Meeting

Practical Model for European Training

Presentation at 38th DIA Annual Meeting

Data Management, Data Validation und Abklärungsprozedur

Presentation at "Data Management und Auswertephase valider Daten in klinischen Studien: die Schnittstelle zwischen Monitoring und Auswertung", Seminar, organized by BPI/Colloquium Pharmaceuticum

Good Clinical Practice for Clinical Investigators

Presentation at Investigator Meeting, organized by Client

Good Clinical Practice für Prüfärzte

Presentation at Investigator Meeting, organized by Client

Beyond ICH GCP - The Hidden Requirements

Presentation and Workshop, organized by Client

FDA IND Requirements for Clinical Trials

Course and Workshop at Client Site

Data Management, Data Validation und Abklärungsprozedur

Presentation at "Data Management und Auswertephase valider Daten in klinischen Studien: die Schnittstelle zwischen Monitoring und Auswertung", Seminar, organized by BPI/Colloquium Pharmaceuticum

ICH GCP - Back to the Principles

Presentation and Workshop at Client Site

GCP Non-Compliance - A Critical Reflection of the Reasons and Possible Ways out of the Dilemma

Presentation in session "Reasons for Non-Compliance with GCP" at the 37th DIA Annual Meeting

ICH GCP für Prüfärzte

Presentation at "Prüfarzt in klinischen Studien" Development Program, organized by KKS Mainz

ICH GCP für Prüfärzte

Presentation at "Prüfarzt in klinischen Studien" Development Program, organized by KKS Mainz

Quality Management in Clinical Research and Data Management

Course at Client Site

Phasen der klinischen Prüfung und ihr Beitrag zur Markteinführung

Presentation at "Inhalte und Fachtermini der pharmazeutischen Industrie", Conference organized by Vision in Business

Data Management, Data Validation und Abklärungsprozedur

Presentation at "Data Management und Auswertephase valider Daten in klinischen Studien: die Schnittstelle zwischen Monitoring und Auswertung", Seminar, organized by BPI/Colloquium Pharmaceuticum

Case Study: Undergoing an FDA Clinical Trial Inspection

Presentation at "Regulatory Challenges of Conducting Clinical Trials in Europe", Conference organized by IIR

Data Management, Data Validation und Abklärungsprozedur

Presentation at "Data Management und Auswertephase valider Daten in klinischen Studien: die Schnittstelle zwischen Monitoring und Auswertung", Seminar, organized by BPI/Colloquium Pharmaceuticum

TQM in der klinischen Arzneimittelentwicklung

Presentation at VDI Quality Working Group

Phasen der klinischen Prüfung und ihr Beitrag zur Markteinführung

Presentation at "Inhalte und Fachtermini der pharmazeutischen Industrie", Conference organized by Vision in Business