Raquel Ballesteros
Raquel Ballesteros
Simmons & Simmons LLP
Brief Introduction
Raquel ranks at the highest positions of international legal rankings in Life Sciences & Healthcare (Tier 1 in Chambers & Partners 2020-2023, Best Lawyer of the year in Life Sciences and Biotechnology 2020 in Best Lawyers) and is an Expert Advisor for the European Commission in a number of digital health and telemedicine projects. Raquel helps clients navigate the increasingly complex regulations applicable to innovative health-related products and services (personalized medicines and new therapies, new vaccines, orphan drugs, genetically modified organisms -GMOs, medical devices and medical software, cosmetics, food and food safety products as biocides and pesticides, etc). In particular, she helps to accelerate such products and services market access, managing the different legal issues and challenges of their life cycle (clinical trials, R&D public funding, marketing authorizations, compassionate uses, product compliance, GMP -Good Manufacturing Practices, pricing and reimbursement, advertising, public procurement, marketing compliance and anti-bribery, privacy and data protection, distribution, traceability, pharmacovigilance, etc). She is also a strong litigator in her areas of practice, with a special focus in regulatory and compliance litigation, public procurement litigation and product liability. She also acts in arbitration proceedings, being regularly appointed as arbitrator in cases before the Spanish main domestic Courts. Raquel is a regular lecturer in the Universidad Carlos III of Madrid, teaching European Pharmaceutical Law and Digital Health Law.
Organizing Committee Information
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