Transparency of clinical trial information is taking on new dimensions, resulting in trial sponsors and research organisations facing a host of new requirements in the EU. This 2017 Workshop leverages learnings from European and US experts as well as prior conference discussions, providing the opportunity to gain insights on how to meet new challenges. The programme is assembled around key themes:
- Impact of the EU Clinical Trial Regulation and EMA Policy 0070 on trial disclosure business processes
- Upcoming legal requirements related to disclosure of clinical research information for medicinal products and medical devices
- Real-world experiences on implementation of the regulations, including fine-tuning and optimising processes to meet the requirements for disclosure, data sharing and data transparency
- Approaches to navigating the patient and ethics committee interfaces, as well as interdepartmental discussions
Attendees will learn from case studies and experiences of experts and their peers.
SUBMIT AN ABSTRACT
DIA is seeking companies who specialize in software that allows anonymization of clinical documents with a focus on delivery to EMA Policy 0070 (Clinical Data Publications) and other similar needs. We would like to provide an opportunity to showcase available tools during our December 6-7 meeting in London. A key objective of this meeting is to help the industry be better prepared to deliver to this new policy. Tools are key to success and we want to have an opportunity to know what options exist in the market for our attendees. If you are interested in participating in this session, please submit an abstract with the following details:
- Product/software tool Name
- High level summary of product capabilities
- Is the tool available for purchase today? If not, when do you anticipate it to be available in the market?
- Do you also offer services along with the product?
- What is your overall experience with anonymizing Clinical Documents?
- What is your overall experience with anonymizing clinical data?
- What anonymization techniques does your tool utilize?
- Can you demonstrate your tool and will you be willing to do so at our meeting in a round robin forum that allows for any registrant to visit your session?
- Any additional information you would like to share with DIA
Developments in relation to implementation of Policy 0070:
- The newest on Implementation guidance from EMA
- Experience from industry on preparing documents for disclosure in relation to the policy
- Technical challenges in document handling
- Facing new challenges such as preparing Anonymisation reports and providing risk assessments
- Legal aspects to consider
- Thinking ahead when preparing documents ready for policy 0070 disclosure
Who should attend?
Who should attend:
- Professionals and experts from areas affected by public disclosure across drug and medical device development (regulatory affairs, scientific affairs, medical writing, clinical operations, medical communication, biostatisticians/biometrics, project management, medical affairs, legal, patent departments, etc)
- Consultants, CROs and companies that offer services for clinical registries, publication planning and medical writing.
- Patient organisations
- Regulatory agencies
- Academic Institutions
- Learn about the latest developments relating to the implementation of the EU policy 0070 from regulators as well as from industry.
- Benefit from the various perspectives on regulatory, legal aspects and practical challenges from large, mid-sized, and smaller sponsor organizations
- Leverage best practices on implementation of the practical implementation through case studies by exchanging views between regulators, industry, patients, academia and other stakeholders
Julie G. Holtzople • Clinical Trial Transparency Operations Director
AstraZeneca, United States
Robert Paarlberg, MS • Principal
Paarlberg & Associates LLC, United States
Merete Joergensen, MBA, MSc • Senior Trial Disclosure Director, Global Clinical Registry
Novo Nordisk A/S, Denmark
Matthias Zerm, PhD • Lead Expert Clinical Trial Disclosure and R&D Processes
Merz Pharmaceuticals GmbH, Germany