Upcoming events
ADVANCED PHARMACOVIGILANCE – MASTERCLASS
27th-28th June 2013
Vienna, Austria
ABOUT THE EVENT
Pharmacovigilance is an arm of patient care. It aims at getting the best outcome of treatment with medicines. Good pharmacovigilance identifies the risks in the shortest possible time after the medicine has been marketed and will help to establish and identify risk factors.
This course is designed for those with at least 2 years experience in Drug Safety. You will be provided with a comprehensive, yet practical assessment of the main Regulations required to produce a compliant reporting Company. The course will also include a ‘whats new’ review for the July 2012 EMA radical change in pharmacovigilance legislation.
BENEFITS OF ATTENDING
By attending this masterclass you will:
- Understand the process of deal-making within the pharmaceutical and biotech industries
- Learn how to choose the right sales approach
- Identify the key elements of the proposition
- Grasp the principles of valuation and know what works best for which purpose
WHO SHOULD ATTEND?
This course is designed to be of maximum benefit to those safety professionals who are working both in the Clinical and Post- Marketing Safety arena. The course covers very diverse activities within the Safety Department and would be advantageous to those who have either multifunction responsibilities or Medical Directors who manage teams in the various disciplines.
ABOUT THE MASTERCLASS LEADER
Our course leader has dedicated more than 21 years of expertise to drug safety issues. As a visionary leader, he is the chief executive officer and director of pharmacovigilance for a leading specialist company providing global clinical and post-marketing drug safety. He is responsible for protecting patients, ensuring that processes are in place and data is documented properly. He reports to 80 countries around the world and addresses issues related to adverse reactions. Prior to his current position he was the head of global drug safety for a multinational pharmaceutical company. He has written a modular book on multinational pharmacovigilance, has written many articles on pharmacovigilance in peer-reviewed journals, and regularly shares his industry knowledge through conducting numerous speaking engagements.
He is affiliated with the Drug Information Association and Special Interest Group for Drug Safety.
For the detailed agenda of the event, participation and sponsorship opportunities please contact us at info@eiccrp.eu or send your request.
AUDIT AND INSPECTION MANAGEMENT – MASTERCLASS
- HOW TO PREPARE AND PASS GCP INSPECTIONS –
27th-28th June 2013
Vienna, Austria
ABOUT THE EVENT
Every trial is subject to audits as well as health authority inspections from time to time. GCP audits and inspections are fundamental elements of managing quality assurance in the pharmaceutical industry.
This course has been designed to provide you with the necessary skills and tools to prepare for audit and regulatory inspection and to facilitate the response and follow-up to the inspection findings.
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 course has been specifically designed to be able to prepare for EMA and FDA inspections. It has been designed to allow plenty of opportunity for discussion and share best practice.
SESSION TOPICS
- Regulatory and QA perspective GCP Inspections
- How to prepare for a GCP inspection? Panic/contingency planning
- How to conduct an internal inspection vs. the conduct of the regulatory inspection.
- The role of your SOP’s
- EMEA/FDA approach to GCP inspections
- The Inspector’s Perspective
- Outcomes of regulatory inspections
- How to respond to a regulatory finding
BENEFITS OF ATTENDING
By attending this 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 preventative action in response to inspection findings
WHO SHOULD ATTEND?
Professionals from pharmaceutical companies, CROs, SMOs and sites, dealing with Quality, GCP, Compliance, Data Management, clinical trial archiving, CRA group heads, line managers, monitors, heads of clinical operations units and anyone whose responsibility includes preparations for audits and inspections.
For the detailed agenda of the event, participation and sponsorship opportunities please contact us at info@eiccrp.eu or send your request.
Other events organized by EICCRP:
COMMERCIAL ASPECTS OF DRUG DEVELOPMENT - MASTERCLASS
19th-20th September 2013
venue t.b.c.
ABOUT THE EVENT
The course is an intense two day programme which includes practical tools and in-depth analysis skills for Business Development Executives coming from the Pharma, Biotech and Contract Reseach Organizations. It is more interactive and based around the in-depth analysis of various case studies. Unlike other courses that focus on a particular skill or aspect, this programme addresses all key steps in the pharma business development process, equipping you with powerful decision-support tools, expert insight into key success factors and time-saving advice.
BENEFITS OF ATTENDING
- Understand the process of deal-making within the pharmaceutical and biotech industries
- Learn how to choose the right sales approach
- Identify the key elements of the proposition
- Grasp the principles of valuation and know what works best for which purpose
- Get expert advice on negotiation strategy and tools, and on how to best conduct the interactions
- Know how to best manage the contract phase
- Avoid financial and legal pitfalls that can break a deal
- Increase your understanding of project management tools and techniques
WHO SHOULD ATTEND?
- Mid- to senior level executives in pharma, biotech CROs whose role increasingly involves business development activities
- Junior to mid-level managers contributing to the business development process. (e.g. technology assessment, business intelligence, etc.) who need a better understanding of the complete business development process
- Mid- to senior level executives in companies providing support or services to Pharmaceuticals.
For the detailed agenda of the event, participation and sponsorship opportunities please contact us at info@eiccrp.eu or send your request.
IMPLEMENTING THE EU PHARMACOVIGILANCE CHANGES - MASTERCLASS dates to be confirmed ABOUT THE EVENT Approximately 8 years in the making, the latest EU pharmacovigilance legislative changes are radical and thorough. Among other things they introduce some completely new elements to European pharmacovigilance practice. This necessitates changes in both procedures and training to implement the new requirements and maintain compliance. BENEFITS OF ATTENDING WHO SHOULD ATTEND? This workshop 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. 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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The legislation, introduced in July 2012, addresses the main regulatory steps of the product lifecycle, with an emphasis on risk management planning and benefit risk monitoring. The pharmaceutical industry, regulators as well as patients and professionals are key actors in this process.
This workshop has been designed to provide a comprehensive coverage of the changes, showing what these changes mean in daily practice. Due to the limited number of participants the discussions are interactive and you are also encouraged to submit any specific questions you may have, to the course Chair before the event.
EU CT DIRECTIVE, REGULATORY REQUIREMENTS – MASTERCLASS
Details of and upcoming changes to the Directive
dates to be confirmed
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.
PROJECT MANAGEMENT FOR PHARMA – MASTERCLASS
dates to be confirmed
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.
PREPARING FOR AUDITS AND INSPECTIONS – MASTERCLASS
dates to be confirmed
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.
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