Upcoming events
PREPARING FOR AUDITS AND INSPECTIONS – MASTERCLASS
16th-17th February 2012
REGISTRATION CLOSED
31st May-1st June 2012
REGISTER AND SAVE 25% BEFORE MARCH 15TH
ABOUT THE WORKSHOP
What do you do when the EMA or the FDA comes knocking? Are you absolutely confident that everyone is fully prepared? Every clinical trial is subject to audits as well as health authority inspections from time to time, verifying compliance with rigorous requirements that have in fact changed significantly over the last few years. In this masterclass you will learn, develop and practice what you need, to be ready when the call comes, taking you through from the announcement to the end of the process.
WHY ATTEND?
GCP regulations and standards apply to clinical trials of investigational pharmaceuticals, biologics and medical devices. Failure to conform to these requirements may result in concerns about data quality and integrity. This intensive course provides a comprehensive overview of how to prepare for audits and regulatory inspection for clinical research activities. It has been specifically designed to be able to prepare for EMA and FDA inspections. The course will allow plenty of opportunity for discussion and share best practice.
BENEFITS OF ATTENDING
By attending the masterclass you will:
- Understand how to prepare for EMA and FDA audits
- Learn how to plan for an audit or inspection including the use of appropriate checklists/EMEA inspection guidelines
- Know how to prepare for audit / inspection interviews
- Acquire a greater understanding of responding to the audit / inspection findings
- Improve your ability to carry out corrective and prevenative action in response to inspection findings
WHO SHOULD ATTEND?
Professionals from pharmaceutical companies, CROs and SMOs and sites, dealing with Quality, GCP, Compliance, CRA group heads, line managers, heads of clinical operations units and anyone whose responsibility includes preparations for audits and inspections.
THE COURSE LEADER
The course leader has almost 20 years of experience in running clinical trials and clinical quality assurance in the pharmaceutical industry, and has held a number of international and senior management QA positions in the pharmaceutical industry. Being an acknowledged author and co-author of several training materials, books and guides focusing on QA, GCP, Laboratory, Manufacturing Practices and Project Management in the Pharmaceutical industry, our course leader is a regular lecturer on conferences and trainings on QA and GCP issues.
For the detailed programme of the masterclass, participation and sponsorship opportunities please contact us at info@eiccrp.eu or send your request.
22nd-23rd March 2012 ABOUT THE EVENT This course is designed for those with at least 2 years’ worth of knowledge in drug safety, and will provide a comprehensive, yet practical assessment of the main regulations required to produce a compliant reporting company. The course will also include a ‘what’s new’ review for the July 2012 EMA radical change in pharmacovigilance legislation. BENEFITS OF ATTENDING WHO SHOULD ATTEND? This course is designed to the maximum benefit of those professionals who work both in the Clinical and Post- Marketing Safety arena. We will cover a wide range of activities within the Safety Department and this course will be be advantageous to those who have either multifunction responsibilities or are Medical Directors who manage teams in the various disciplines. COURSE LEADER The course leader has over 15 years experience working in the pharmaceutical industry followed by several years in a consultancy company. During this time the responsibilities included involvement in establishing pharmacovigilance in companies, performing audits across the globe and helping with regulatory inspections. For the detailed agenda of the event, participation and sponsorship opportunities please contact us at info@eiccrp.eu or send your request.
ADVANCED PHARMACOVIGILANCE – MASTERCLASS
REGISTRATION CLOSED
PROJECT MANAGEMENT FOR PHARMA – MASTERCLASS
26th-27th April 2012
REGISTER AND SAVE 25% BEFORE FEBRUARY 15TH
ABOUT THE EVENT
This Project Management course designed specifically for the pharmaceutical industry (including professionals working in Regulatory Affairs and Clinical Research) – also applicable to those in Medical Device and Animal Health Industries. This course has been designed to provide you with understanding of project management skills, including both technical and interpersonal skills. The course will show you how to use these project management skills to gain the most benefit trough interactive sessions.
BENEFITS OF ATTENDING
- Increase your understanding of project management tools and techniques
- Learn to apply the project management processes to your everyday working practices
- Understand how to blend technical aspects and interpersonal skills
- Examine the competencies for an effective project manager
- Discuss how to get the best results in a team environment
WHO SHOULD ATTEND?
This course has been specifically designed to address the needs of professionals who are – or will be – involved in pharmaceutical, medical device and animal health projects. The programme will be of benefit for project team members, newly appointed leaders, managers. In addition it will be useful for team leaders who want to improve their project management skills.
COURSE LEADER
The course leader has more than 15 years experience in the Pharmaceutical Industry, has worked as a Clinical Research Manager, Audit Director and as Head of a Training Department. The trainer is an internationally recognized expert on regulatory requirements in Clinical Research.
For the detailed agenda of the event, participation and sponsorship opportunities please contact us at info@eiccrp.eu or send your request.
REGULATORY REQUIREMENTS – MASTERCLASS
Proposed Changes to the EU CLINICAL TRIAL Directive Requirements
17th-18th May 2012
REGISTER AND SAVE 25% BEFORE MARCH 1ST
ABOUT THE EVENT
This masterclass will take you through the regulatory guideline requirements for clinical research in Europe, including the proposed changes to the CT Directive and the key requirements, which impact the trials carried out in Europe. Attending this event will help ensure that you are familiar with the regulations for running clinical trials and with the changing requirements. The course will highlight the most important of these key requirements and changes and how these are likely to impact trials now and in the future for both pharmaceutical companies and study sites.
BENEFITS OF ATTENDING
- Discuss the Clinical Trial Directive process for overcoming the problems of the Directive
- Gain an overview of the EU Clinical Trial Directive and GCP Directive
- Understand Clinical Trials Authorisations
- Understand the legal aspects of clinical trials
- Ensure you comply with Pharmacovigilance & Adverse Event Reporting
- Discuss clinical trial data management including EDC and e-source
- Understand FDA requirements including recent developments
WHO SHOULD ATTEND?
Professionals in pharmaceutical, biotechnology CRO and SMO companies, or study sites including investigator initiated studies. It is also relevant to those who liaise / support clinical trial personnel (such as regulatory affairs, clinical trial supply, drug safety quality assurance, document management, legal, regulatory authorities and all other professionals who want to know more about regulations and guidelines covering clinical trials.)
COURSE LEADER
The course leader has more than 15 years experience in the Pharmaceutical Industry, has worked as a Clinical Research Manager, Audit Director and as Head of a Training Department. The trainer is an internationally recognized expert on regulatory requirements in Clinical Research.
For the detailed agenda of the event, participation and sponsorship opportunities please contact us at info@eiccrp.eu or send your request.
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