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PleaseReview and Ideagen are delighted to partner with AMWA for this event to aim to make the life of the medical writer easier and more efficient. We are pleased to welcome thought leaders in the Life Sciences and Medical Writing fields who aim to provide an educational experience concentrating on best practices for review management, documentation, and interpersonal challenges within the context of Medical Writing.

Learning Objectives 

 After participating in this webinar, participants should be able to 

• implement best practices for review management that leverage technology, project management skills, and interpersonal savvy.

•apply documentation best practices to promote a proactive and transparent quality culture.

•hold individuals accountable and more effectively navigate interpersonal challenges within the context of reviews.

Target Audience

PleaseReview and Ideagen is relevant to all personas in Life Sciences, Pharmaceuticals, Clinical Research organizations, Aerospace and Defence and all those conducting general bid and proposal work. 

About the Presenters

Hugh Devine BSc Hons CDPSE at CompliancePath is trained in US & EU IT Regulatory requirements and has led pilot projects for key IT systems within the regulated space. He has significant experience in Product and IT Design Control Validation, Data Centre qualification, Product and IT Quality Strategies, System Implementation, Computer System Validation, commercialisation of Software as a Service applications all for the Life Science and Health IT Industries inclusive of HIPAA and GDPR compliance. Hugh has led high growth start-ups in both the US and EU and has extensive experience in strategic planning and partnerships to help develop and resource customer solutions. Hugh holds a Bachelor of Science Honours degree in Technology and Business from the University of Strathclyde in Glasgow.

Jason Webb is Head of Technology at Ideagen. Jason is an experienced software industry veteran who has worked on everything from satellite systems to large scale social media sites. He currently runs Ideagen’s cutting edge Research and Innovation departments that works on diverse topics such as machine learning, application architecture and ethics. Ideagen R&I is a pragmatic research department that delivers real value for both our customers and our business.

Kim Norris is Director of Medical Writing at uniQure, a Netherlands/US-based gene therapy company whose mission is to deliver curative gene therapies to transform the lives of patients. Kim has over 25 years of experience with clinical/regulatory writing as well as medical affairs writing. Her experience includes working at 2 CROs, large companies, and small start-up companies. She has developed in-house medical writing groups for several companies, building the infrastructure, identifying, and overseeing contract writers, acquiring technology to support medical writing deliverables, and developing and propagating a distinct company style that is fully compliant with regulatory requirements. Kim leads her department but also works in the trenches as a medical writer, editor, and QC specialist. Her experience ranges from pre-IND to post-marketing activities. submission. 

Abigail Shetler is a Senior Medical Writer at uniQure. Abigail entered the regulatory writing field over 6 years ago, bringing with her a wealth of technological expertise. She is a board-certified Editor in the Life Sciences (ELS), with an extensive understanding of multiple types of submissions, detailed knowledge of regulations and guidance documents, and expertise in technology and software. Abigail has led writing, editing, publishing, and submission activities for a variety of biotech companies and contract research organizations. She has expert knowledge of writing, review, and publishing software and tools and has acted as IT support for some organizations. in-depth quality control of data and written content, and alignment with best practices and standards

Stephen Ferrell is a recognized expert in regulatory compliance in the Pharmaceutical, Medical Device and Biotech space. Mr. Ferrell was co-founder of CompliancePath Ltd, a Scottish and US Compliance services company that support regulated clients all around the world. Mr. Ferrell has held executive and senior level management positions with a number of technology firms in the Life Sciences. Stephen has implemented Quality Management Systems at several companies at both the corporate and divisional level and has hosted and conducted countless audits across the GxP disciplines, ISO13485 (inclusive of IEC62304/ISO14971), ISO27001, SOC 1 & 2, EHNAC and FEDRAMP. Mr. Ferrell represents the Scottish Life Sciences Association in the USA and was a signatory on the historic ‘Turnpike agreement’ which created collaborative channels for US & Scottish Life Sciences companies to share knowledge and expertise. Mr. Ferrell is a member of the ISPE GAMP Steering committee, formerly chaired the Cloud Special Interest Group and was the project lead for the ISPE GAMP IT Infrastructure Control and Compliance Guide published in August of 2018. Mr. Ferrell is a trusted advisor to the US FDA, having provided CSV, Cloud and Data Integrity training directly to field consumer safety officers. Mr. Ferrell’s relationships with the US FDA led to the ISPE GAMP IT Infrastructure Control and Compliance Guide being endorsed by CBER, CDER and CDRH as well as the MHRA in the UK.