5th EMWA Symposium
Transparency and Disclosure of Clinical Regulatory Documentation
Thursday 4 May 2017
International Convention Centre, Birmingham, UK
The fifth EMWA one-day symposium will focus on the rapidly changing field of regulatory public disclosure requirements and how these changes impact the consumers, the writers, and how information is disclosed. Through the onset of regulatory public disclosure, the importance of “smart writing” – and thus of the medical writer role - has become paramount. Regulatory public disclosure imposes new demands on information presentation in documents, terminologies, document structure, and consistency. There are also overlaps with disclosure aspects in pharmacovigilance.
In this symposium, speakers and panelists will present and discuss approaches, with reference to:
- Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) and the WebRADR (Recognising Adverse Drug Reactions) Project
- The importance of social media in pharmacovigilance
- EMA Policy 0070
- Public disclosure regulations/requirements in the US and the EU
- The German Institute for Quality and Efficiency in Healthcare (IQWIG) perspective as a “user” of publically disclosed clinical documentation/information (with emphasis on the consumer part)
- The medical writer’s perspective on the public disclosure of clinical documents/information (with emphasis on the writing part)
- The company perspective on the public disclosure of clinical documents/information (with emphasis on how documentation/information is disclosed)
The symposium will have a well-paced mix of presentations and panel discussions after the morning and afternoon sessions to ensure free flowing dialogue between speakers and panellists and ample opportunity for the audience to raise questions.
ContentThe Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action was aimed to help medicine regulators operate pharmacovigilance systems to the EU legislative requirements. Regulators have worked together, and delivered recommendations, guidance, learning materials and other tools to improve the skills and capability in the PV network.
Launched in September 2014, WEB-RADR: Recognising Adverse Drug Reactions is a three –year initiative funded by the IMI to utilise the powers of social media and new technologies for pharmacovigilance purposes. WEB-RADR is developing a mobile app for patients and healthcare professionals to report suspected adverse drug reactions to national EU regulators, and investigating the potential for publicly available social media data for identifying drug safety issues.
ContentFirst experience with completing the EMA Policy 0070 process for Zurampic will be shared. This will include pitfalls, best practices, and evolving expectations.
ContentThe regulations governing the disclosure of regulatory documentation are rapidly developing, e.g., the EMA Policy 0070 updated, clarification webinars on the EMA Policy 0070 were held, the US FDA Final Rule became effective, and EU Guidelines on Summaries of Clinical Trial Results for Laypersons pending issue. This session will highlight the key changes to regulations and guidance since May 2016.
ContentIQWiG, Germany’s Health Technology Assessment (HTA) Agency, examines the benefits and harms of medical interventions for patients. IQWiG’s assessments provide evidence-based information to decision makers in the German health care system. In addition, the outcomes of IQWiG’s assessments are presented as easily understandable health information for the general public.
To fulfill its responsibilities, IQWiG requires complete information on the methods and results of all relevant clinical studies of an intervention under assessment. The session discusses the use of clinical regulatory documentation within IQWiG’s assessment procedures.
ContentThe European Medicines Agency Policy on publication of Clinical Data for medicinal products for human use (policy 0070) and the new EU Clinical Trial Regulation, specifically Annex IV and V, are both initiatives to increase transparency of information on medical products and data on which regulatory decisions are based. The overall ambition is to support patients and society. These new requirements will have impact on document structure, the working procedure, and the role of the Medical Writer. This session will elaborate on the challenges but also give guidance on potential solutions and future ways of working.
ContentEMA Policy 0070 and the challenges facing the pharmaceutical industry
This session will provide insights into sponsor-internal processes to ensure compliance with EMA Policy 70. For a sponsor, the challenge is to satisfy the regulatory needs whilst protecting both personal data and commercially confidential information in addition to maintaining fast and efficient processes. During the talk, we will address the key processes for provision of transparency-ready clinical documents. Other topics are the information and training of the relevant departments and the need to consider the general public as a secondary audience.
ContentClarity and Openness in Reporting: E3-based (CORE) Reference was developed in part to facilitate preparation of disclosure-ready clinical study reports mandated by the EMA in a timely and cost-effective manner, and without risking inadvertent disclosure of sensitive information. This short session will explain how CORE Reference can be used to enhance clinical data transparency in the real world. The results of the CORE Reference Utility Survey, conducted one year after the launch of CORE Reference, will also be presented