Translating Documentation and Communication in Clinical Research - Virtual Conference 2020

Biography: Project Financial & Planning Governance, Contractual Liabilities, Meeting and Program Governance, Knowledge Management

Session Details: What Do You Need To Know When Translating Your Regulatory Document 24-11-2020, 4:00 pm View In Agenda

Biography: Mrs. Erlich is a senior regulatory, clinical trials, and compliance expert for the health-care and medical device industry. She has served as a senior management member and held VP positions in national startups and international health-care companies since 2003. As part of her job, she managed large company teams, delineated the regulatory and compliance strategy and led its implementation, leading to multinational market clearance, including the EU, USA, South America and the Japanese market. She also designed and managed multinational multisets clinical trials and submissions. In addition, since 2001, she also served as a senior consultant in the PushMed group and N.G.I.T, for more than 70 medical device companies in miscellanies clinical fields. As a consultant she established quality systems, lead the design control process to support successful regulatory submissions, supported the company during CE audits and FDA inspections, and tailored regulatory and clinical strategy. She also held meetings with regulatory bodies, including notified bodies and FDA, and managed clearance file submissions, such as a Technical File, 510(k) notices and post market activities. Tsvia Erlich joined ConTIPI Medical, as Regulatory and Clinical Affairs officer in 2007. She holds a BSc. degree (cum laude) in Biochemistry and Food Engineering from the Hebrew University in Jerusalem. Later, she graduated the Technion Institute of Technology, Haifa and received her M.Sc. degree (cum laude) in Biotechnology and Food Engineering, in 1993.  During that time she completed her research in the field of protein engineering at the laboratory of Professor Yuval Shoham, at Technion Institute. She holds CQE and CQM certificates since 1999 and is an active member of RAPS and she lectures at national and international conferences.

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Biography: Ensures that processes related to clinical documentation and training, meet quality/regulatory standards. Develops proactive strategies to implement GCPcompliant processes. Monitors and assesses clinical trial disclosure requirements, to ensure that the department is covered by adequate procedures and systems for training and that training is delivered in accordance with Department needs, Company’s policies and SOPs; support during Inspection/Audit; to support the Study Team to ensure a complete and accurate TMF through documentation quality and consistency; to develop TMF culture through all the clinical process and ensure the implementation of the eTMF.

Session Details: Case Study: In-House Language In the Correspondence of a Clinical Trial 24-11-2020, 10:00 am View In Agenda

Biography: his position participates in tactical & strategic planning to develop a state-of-the-art labeling design organization. Lead initiatives related to development and implementation of design systems in preparation for upcoming product launches and ongoing commercial operations. Work with functional groups including Regulatory Affairs, Quality Assurance, Commercial, Legal, Packaging Engineering, and Manufacturing to further refine the process for design & development of clinical and commercial labeling. Work with Commercial and Regulatory to develop and finalize graphic elements and product branding elements of labeling for EU, US and ROW. Develop estimates for labeling component printing quantity and cost requirements to support needed clinical and commercial activities. Review and approve packaging artwork for accuracy, regulatory requirements and production requirements. Lead drafting, review, update (as needed) and approval of function SOPs. Identify, develop and lead opportunities for continuous improvement for deliverables and processes. Lead sub-groups and teams as required to assist in product launches. Evaluate capabilities and capacities of current or proposed suppliers. Work with bluebird bio’s Supplier Relationship Management & Quality teams to qualify and on-board labeling/packaging suppliers. Participate in technical supplier audits. Be single point of contact for suppliers and coordinate with cross functional team to review and resolve supplier service performance expectations to ensure bluebird bio requirements are being met. Work with Finance team to create/maintain label design budget, PO creation and invoice payments. Lead design activities for creating labeling/packaging artwork, preparing associated specifications, managing related electronic labeling systems and quality systems and coordinating printing for both clinical and commercial labeling.

Session Details: Translation Error Equals Artwork Error – Getting It Right The First Time 24-11-2020, 5:00 pm View In Agenda

Biography: Responsible for developing EU MDR localization strategies across Medtronic businesses and functions. Engaged in development of industry guidance related to interpretation of EU MDR requirements. Focused on implementing efficient localization strategies that result in high quality, consistent localized content that meets the requirements of notified bodies and provides clear information to all end users including healthcare providers and patients.

Session Details: Post Marketing Translation Considerations You Need To Know 24-11-2020, 5:30 pm View In Agenda

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Session Details: Challenges In The Translation of Clinical and Regulatory Documents of Medical Devices 24-11-2020, 12:10 pm View In Agenda

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Session Details: 5 Translation Considerations You Need To Know When Developing a Patient Consent Form 24-11-2020, 2:50 pm View In Agenda

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Session Details: Language Considerations For Patient Consent Forms For The Pharma Industry 24-11-2020, 1:20 pm View In Agenda

Biography: Theo Raynor researches how patients can be supported to make good decisions about their medicines and their health - notably through the provision of consumer medicines information - the written and spoken information available to people about their medicines. He spent 20 years practising as a hospital pharmacist, combining practice with research and teaching, before moving into academia in 1996. He became the inaugural Professor of Pharmacy Practice at the University of Leeds in 2000, where he led a highly active practice research programme. This work was complemented by the company which he co-founded, Luto Research, which spun out of the University in 2009. Theo remains an academic adviser to the company - see below. Theo was appointed in 2010 to the Royal Pharmaceutical Society ‘Expert Advisory Panel on Pharmaceutical Science’ - now reformed as the RPS 'Science & Research Board'. In a video commissioned by the Royal Pharmaceutical Society, Theo describes his research and its focus on making an impact on helping people take their medicines safely and effectively. He was awarded the title of Emeritus Professor in 2017, and now works part-time, continuing his work at research, practice and policy level in the UK, US and Australia.

Session Details: Excellence in Communication: How combining good practice in information writing and design with User Testing can transform your patient information sheets 24-11-2020, 2:20 pm View In Agenda

Biography: I have experience writing regulatory documents, including clinical study reports, protocols, and investigator's brochures, in a variety of therapeutic areas. I also lead and am committed to the development process of patient-forward summaries that communicate clinical trial results in a non-promotional, unbiased, and easy-to-understand manner for both the patient community and the general public.

Session Details: Keeping the End In Mind: Patient-Forward Techniques To Foster Clear Communication For Disclosures and Lay Summaries 24-11-2020, 4:30 pm View In Agenda

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Session Details: Keeping the End In Mind: Patient-Forward Techniques To Foster Clear Communication For Disclosures and Lay Summaries 24-11-2020, 4:30 pm View In Agenda

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Session Details: Case Study: Sanofi's In-House Translation Services 24-11-2020, 3:20 pm View In Agenda

Biography: Stephane Millet is General Manager of Operations for North America at Acolad USA. In this role, he is responsible for developing strategic processes that will drive operational excellence within the Acolad Group. Mr. Millet also serves as Co-Lead of Life Sciences Operations, ensuring the optimization of workflows and localized content for a highly regulated industry. Prior to joining Acolad and Telelingua in 2010, Mr. Millet worked as a Translation Manager in diverse operational functions and before that led the translation department – as a translator and project manager - at Alienware. Mr. Millet is a graduate of the Faculty of Translation Studies, Linguistics and Cultural Studies of the Johannes Gutenberg University in Mainz/Germersheim, Germany

Session Details: Translation as a Critical Milestone In Clinical Trials 24-11-2020, 10:30 am View In Agenda

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Session Details: Lost In Translation 24-11-2020, 11:10 am View In Agenda

Biography: Dr. Jouravleva has over 20 years of leadership experience in varying aspects of the life sciences industry and clinical research. She has supported clinical trials working with various pharmaceutical and biotech companies and contributed to approvals by various regulatory agencies, numerous pharmaceutical, diagnostic and device products. Dr. Jouravleva currently supports US Oncology Research, a clinical trial site management organization representing approximately 160 locations across the United States, as the Director of Research Operations overseeing Regulatory Affairs, IRB and the Complementary CRO services groups. She holds Master of Science and Ph.D. degrees in Biology and focused her thesis on genetics of pathogenesis in Vibrio cholerae.

Session Details: Beyond Age, Race and Gender: Improving Diversity in Clinical Trials 24-11-2020, 9:30 am View In Agenda

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Session Details: How AI and Technology Address the Need for Speed in Clinical Studies 24-11-2020, 12:40 pm View In Agenda

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Session Details: Innovations In Linguistic Validation For Patient Centricity 24-11-2020, 1:50 pm View In Agenda

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In his role at SDL Chris McCourt helps sponsors and CROs to communicate with patients, physicians and other stakeholders in global clinical trials – in their language. SDL’s translation support for clinical studies allows global clinical professionals to recruit, enrol and retain patients more effectively; to promote effective communication among investigators; to report results and critical milestones of studies; and to monitor product safety internationally.

Session Details: Case Study: Increasing Operational Efficiencies for Translations 24-11-2020, 11:40 am View In Agenda

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Session Details: How AI and Technology Address the Need for Speed in Clinical Studies 24-11-2020, 12:40 pm View In Agenda