Announcing two new EMWA Special Interest Groups
EMWA launched the Pharmacovigilance Special Interest Group (PV SIG) at The Hague conference in November 2015. PV SIG is a talking shop for the fast developing area of pharmacovigilance (PV) and PV writing. PV SIG delves into issues that impact the PV documents that we write, and with the direct involvement of regulators planned for forthcoming PV SIG meetings at EMWA conferences, you can ask the regulators the questions that matter to you.
EMWA members can access a growing resource of PV-related materials, including the PV SIG launch video, at the dedicated PV SIG area on the EMWA website (under members only/special interest groups).
Regulatory Public Disclosure SIG
As EMWA and AMWA (American Medical Writers Association) publish the open-access resource CORE (Clarity and Openness in Reporting: E3-based) Reference in May 2016, EMWA plans to launch the Regulatory Public Disclosure SIG (RPD SIG), as a natural follow-up to CORE Reference at the EMWA conference in Munich in May 2016.
The concept of public disclosure is of special interest to the RPD SIG because of (i) its impact on the content and structure of standard regulatory documents, (ii) the expectation that the range of regulatory documents impacted will burgeon in the coming years, and (iii) that public disclosure will create the need for new documents which the medical writer will support.
Why is Public Disclosure of ‘Special Interest’ to Regulatory Medical Writers?
‘Public disclosure’ has different meanings for different groups of medical writing professionals:
- Publication professionals understand it to mean the publication of all research findings whether the outcomes are negative or positive; the disclosure of funding; disclosure of involvement of medical writers in publication development; conflict of interest etc.
- Regulatory professionals understand it to mean the:
- Registration, status reporting, and results posting of clinical studies in publically accessible internet registries
- Upon-request or proactive sharing of clinical regulatory documents (e.g. synopses, clinical study reports, clinical overviews, clinical summaries) and/or individual patient data
- Publishing of clinical trial results in journals.
The concept of public disclosure is of special interest to the RPD SIG because of (i) its impact on the content and structure of standard regulatory documents, (ii) the expectation that the range of regulatory documents impacted will burgeon in the coming years, and (iii) that public disclosure will create the need for new documents which the medical writer will support. Europe is leading the world in regulatory public disclosure regulation and legislation, and EMWA must be involved in this important ‘conversation’.
Public Disclosure of Clinical Regulatory Documents: A Fast-developing Area
Your Executive Committee are launching the RPD SIG because medical writers need to understand how developments in this area affect the clinical regulatory documents that they write.
The RPD SIG Chairs – Dr Christopher Marshallsay and Ms Tracy Farrow – are assembling a team to survey this fast-developing area, with the aim of sharing information and best practices with EMWA members.
Join the Debate
The EMWA SIGs allow EMWA and its members to contribute to important conversations around topics that we know will impact our industry in the coming years. You may have colleagues interested in joining the EMWA SIGs to debate, and share best practice and resources.
Please tell them about the EMWA SIGs. Those with an interest should email firstname.lastname@example.org to join EMWA.
Are you unable to attend the SIG meetings in person? EMWA members can benefit from archival recordings of all SIG meetings posted on the EMWA website.