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Raquel Billiones

Company:
Takeda
Qualification:
Leader background:
Raquel has a PhD in Biology and more than 25 years combined experience in scientific and clinical research. She has been a medical writer for more than 13 years, with core competencies in writing clinical trial and regulatory documents for pharmaceuticals and medical devices. Her medical device experience includes writing clinical investigation plans and reports and clinical evaluation plans and reports for CE Class II and Class III medical devices. Her experience also includes transparency, disclosure and patient data protection in clinical trial data reporting. Her current position is Senior Director, Head of Medical Writing at Takeda Vaccines. Previously, she worked for a mid-sized global CRO where she established and led a small team of writers and support staff located in the US, Europe, and Asia. Raquel is an active member of EMWA, serving in various roles, including as Executive Committee member (2015-2017), associate editor of MEW (2010-present), internship advocate, workshop leader, and member of the Medical Device Special Interest Group (MD SIG).
Workshops:
Personal Data Protection in the Clinical Trial Disclosure Era: Compliance with EMA Policy 0070 and the GDPR
    Level: Foundation Area: Drug Development
    Code: DDF37 Duration: 03:00:00
Regulatory Medical Writing for Newbies
    Level: Area: Not for credit
    Code: SGRMW Duration: 00:30:00
Going from Pharma to Medical Devices
    Level: Foundation Area: Medical Devices
    Code: MDF2 Duration: 03:30:00
General Data Protection Regulation (GDPR) and EMA Policy 0070 - Linkage and Overlaps
    Level: Area: Expert Seminar Series
    Code: ESS24 Duration:
Going from Pharma to Medical Devices
    Level: Foundation Area: Medical Devices
    Code: MDF2a Duration: 03:30:00