Conducting Clinical Trials in the EU Agenda

Untitled Document

10:00 a.m. – 10:10 a.m.

Introduction and Explanation of How a Virtual Conference Works

10:10 a.m. – 10:55 a.m.

Understanding Regulations in Austria, Germany, Hungary, Poland
The complexity of running clinical trials in EU countries has increased substantially. Indeed, countries such as Austria, Germany, Hungary, Poland offer tremendous advantages yet each also has its country-specific advantages that can trip up even the savviest sponsor. The first and most important step to develop successful clinical trials in the EU is to understand how the EU differs from the FDA and to get on the ground experience to comply with each country’s unique requirements.

Attendees will learn:
  • Delve into the key clinical trial regulations in Austria, Germany, Hungary, Poland
  • Understand why variations in regulatory procedures within each of these countries should be monitored closely
  • Discover the characteristics of research and ethics committees including the role they play in their respective country and what it means for both sponsors and sites
  • Details of case study involving Polish submission

Mariusz Olejniczak, General Manager, Head of Clinical Project Management, Assign Clinical Research Poland; Niki Girsa, Head of Clinical Project Management, Assign Clinical Research GmbH

10:55 a.m. – 11:40 a.m.

Securing Insurance for Running Trials in EU Countries
To run a trial in the EU typically involves three basic types of insurance:  patient, error/omission and malpractice.  In response to the CTD, countries developed a confusing patchwork of local requirements.  Sponsors and researchers must be keenly aware of all the requirements to satisfy regulatory requirements and integrate insurance into their risk management programs. 

Attendees will learn:

  • How to address the variability of clinical trial insurance/indemnity requirements across Europe
  • Can a risk based approach address clinical trial insurance variability?
  • How the cost of clinical trial insurance impacts the costs and resources necessary for conducting for clinical trials
  • The latest steps Europe is taking to address clinical trial insurance variability

Dr. Denis Lacombe, Scientific Director, European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium

11:40 a.m. – 12:00 p.m.


12:00 p.m. – 12:45 p.m.

Protection and Transfer of Clinical Trial and Adverse Event Data within the Patchwork of EU Regulations
Drug and device companies face many data privacy and security challenges in conducting global clinical trials. The requirements differ from region to region, and also differ within the EU member states.  Enforcement can include fines of up to $1,000,000 per violation, as well as interruptions to clinical trials until the regulators are satisfied with compliance — and unannounced inspections. Knowing the privacy landscape and requirements in advance, and planning ahead, can help you keep your trial on track and avoid costly mistakes and delays.

Attendees will learn:

  • What the privacy and security laws require in terms of collecting, processing, transmitting and retaining clinical trial and adverse event data
  • The restrictions on transferring EU personal data to other countries—including the US
  • How to prioritize the compliance requirements and address them on a global level
  • Recommendations for compliance for your organization

Joan Antokol, Managing Partner, Park International, formerly Vice President and Global Head of Privacy, Novartis Pharmaceuticals and Head of Product Liability Litigation, Hoffmann-La Roche, Indianapolis, IN

12:45 p.m. – 1:30 p.m.

Managing Postmarket and Pharmacovigilance Related Trials in the EU
The advent of new regulations in the European Union for both clinical and post marketing safety has left both sponsors of clinical trials and license holders of marketed products in an increasingly difficult position. Understanding the various complexities that require different reporting strategies in order to be compliant for the European regulators can often be a burdensome task. The aim of this talk is to describe the key requirements for understanding pharmacovigilance activities to remain compliant.

Attendees will learn:

  • Clinical Safety Reporting in the EU
  • Post Marketing Safety rules for the EU
  • Compliance for Regulatory Inspections

Graeme Ladds, Director, PharSafer Associates Ltd

1:30 p.m. – 2:30 p.m.

Lunch Break

2:30 p.m. – 3:15 p.m. 

Case Study of Conducting EU Studies from a US Virtual Biotech Company
A common business model for small biotech and pharmaceutical companies is to outsource most clinical and regulatory activities. The selection of outsource suppliers needs to take into consideration the need to control cost, quality and time.  One-way to maintain this control is to establish different service organizations for different activities such as clinical activities, data management/statistics, and regulatory. Another is to select a company that can provide the level of competence and flexibility to provide the services to the virtual company.  Manufacture in the US for shipment to the EU requires knowledge and compliance withthe Clinical Trial Directives QP requirements.  A common problem that delays start-up is the interfaces with the CTA application and EC applications.

Attendees will learn:

  • Best practices for selecting CROs and tips for maintaining control
  • Avoiding the landmines of manufacturing and shipping issues
  • Navigating the differences in CTA and EC applications

Dr. Jack McLane, Vice President, Clinical and Regulatory Affairs and Chief Operating Officer, Clinquest, Boston, MA

3:15 p.m. – 4:00 p.m.

Results of the “Road Map Initiative For Clinical Research in Europe” Workshops — Where Does the Road Lead Us?
On March 17 in Brussels, all stakeholders in the clinical research  process came together to further optimize and prioritize various reform proposals with the aim to design a final proposal to the Commission for an overall new regulatory environment for clinical trials in Europe that attracts and encourages clinical research in Europe to the benefit of the patients.  This presentation will detail the final proposal and its chances at passage.

Attendees will learn:

  • The current regulatory environment issues for clinical trials in Europe and first attempts for improvement
  • The proposals made by the “Road Map Initiative for Clinical Research in Europe”
  • The current level of consensus on these proposals amongst the stakeholders in clinical research

Dr. Ingrid Klingmann, Chairman, European Forum for Good Clinical Practice, Brussels, Belgium

4:00 p.m. – 4:15 p.m.

Chairperson’s Closing Comments and Adjournment

How does this virtual conference work?

The Conducting Clinical Trials in the EU Secrets Revealed for Managing Speedy and Compliant Trials Virtual Conference takes all the best elements of the best live conference you’ve attended and avoids all the negatives. It delivers valuable clinical trial development intelligence using the internet for visual components and your speakerphone for the accompanying audio.

All you do is go to the specified website on the day of the event and dial the specified toll-free telephone number, both provided in your registration confirmation. That’s all there is to attending.

Then, relax at your desk or in your conference room, enjoying summit sessions featuring PowerPoint slide presentations, helpful handouts and Q&A opportunities where specific attendee questions will find direct answers from leading supply chain professionals.

What are the top benefits of a virtual conference?

Highly effective communication: This event uses internet and audioconferencing to create a seamless interface and deliver vital compliance and management advice using technology found in every workplace.

Great value: Select as many of your colleagues to attend as you wish and educate everyone for one low price, with no travel, lodging or per diem expenses.

Stress-free: No hotel or airport nightmares because you never have to leave your building. You’ll feel like you’re off-site at a top-flight conference, until you realize how easy it is to get things done during breaks.

Efficient: You can assign your staff to different sessions.  Staffers can go to the sessions that most pertain to their responsibilities.

Content-rich: This virtual conference addresses your most challenging, complex and frustrating supplier quality problems.

Interactive: No one-way street, you’ll have plenty of opportunities to ask questions and get involved.

Up to the minute: This program will be up to the minute with the latest changes initiated by the FDA and international regulatory bodies incorporated into the event.

Comprehensive: You’ll hear from six industry experts all in the course of one day.