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Protecting and Utilizing Your Data in the Life Sciences Ecosystem

Life sciences companies continue to face a myriad of requirements to ensure compliance with a highly regulated industry environment. As businesses innovate in a digital and data-driven world, the interplay between health and data regulations is becoming increasingly complex and challenging.

Explore Data PULSE, a platform that helps you to navigate the complex landscape of data, regulatory and IP protection concerns throughout various stages of the medical product life cycle.

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ACCESS DATA PULSE

The Data PULSE platform identifies some key issues to mitigate risk and optimize business strategies during the R&D, market authorization and post-market study stages. Navigating these intricate and interlinked laws is crucial to provide better patient care, develop new products, mitigate risk and avoid compliance failures.

For a focused discussion, please contact us or reach out to a key contact in your region listed below:

CONTACT US

Author

Anne-Marie Allgrove is a partner in the Sydney office of Baker McKenzie. She is the Global Chair of the Firm’s IP, Data and Technology Practice. Anne-Marie is recognised in both Chambers and The Legal 500 as a leading individual and was named a Best Lawyer of the Year for Privacy and Data Security in 2020.

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Kherk Ying Chew heads the Intellectual Property and Dispute Resolution Practice Groups of Wong & Partners. She has decades of experience in IP, commercial litigation, corporate compliance, information technology and Internet regulatory issues. She is ranked in Tier 1 for IP in Malaysia by Chambers Asia Pacific which has noted that Kherk Ying is "an acclaimed figure in the sector, drawing praise as a lawyer who is 'really commercial, very practical' and 'knows her subject impressively well." Asia Pacific Legal 500 inducted her into its Hall of Fame in 2021 for IP, it had commented that she is "highly respected for contentious and non-contentious work". Kherk Ying was also named in Benchmark Asia-Pacific’s Top 100 Women in Litigation for IP and Commercial Transactions (2020-2021). Kherk Ying won the Women Lawyer of the Year at the ALB Malaysia Law Awards in 2019. She is highly regarded for IP litigation, and has been named the "Best Female Lawyer in IP Litigation" by Euromoney Asia Women in Business Law Awards 2014. She is also recognised as a Tier 1 lawyer in enforcement and litigation by the World Trademark Review 1000, and ranked as a Tier 1 litigation and transactions professional by IAM Patent 1000. Kherk Ying is a registered trade mark, patent and design agent in Malaysia and the principal author of the CCH published Intellectual Property Laws of Malaysia. She is among the few selected trainers for an IP valuation course by Intellectual Property Corp of Malaysia (MyIPO) and is an accredited IP valuer by the World Trade Institute.

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Divina Ilas-Panganiban is a partner in Quisumbing Torres’ Intellectual Property, Data and Technology Practice Group and co-heads the Technology, Media & Telecommunications (TMT) Industry Group. She participates in initiatives of Baker & McKenzie International of which Quisumbing Torres is a member firm. She is a member of Baker & McKenzie International's Asia Pacific TMT Steering Committee. She currently serves as the Vice-President and Director of the Philippine Chapter of the Licensing Executives Society International, the Chairperson of the Committee on Intellectual Property Rights, The American Chamber of Commerce of the Philippines, and the Chairperson of the Committee on Intellectual Property Rights of the European Chamber of Commerce. Divina heads the Subcommittee for East Asia and the Pacific of the Unreal Campaign of the International Trademarks Association (INTA) and is a Certified Information Privacy Manager by the International Association of Privacy Professionals (IAPP).

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Marcia Lee is a Special Counsel in Baker McKenzie Hong Kong office.

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Ren Jun Lim is a principal with Baker McKenzie Wong & Leow. He represents local and international clients in both contentious and non-contentious intellectual property matters. He also advises on a full range of healthcare, as well as consumer goods-related legal and regulatory issues. Ren Jun co-leads Baker McKenzie Wong & Leow's Healthcare as well as Consumer Goods & Retail industry groups. He sits on the Law Society of Singapore IP Committee and on the Executive Committee of the Association of Information Security Professionals. He is also a member of the Vaccines Working Group, Singapore Association of Pharmaceutical Industries, a member of the International Trademark Association, as well as a member of the Regulatory Affairs Professionals Association. Ren Jun is ranked in the Silver tier for Individuals: Enforcement and Litigation and Individuals: Prosecution and Strategy, and a recommended lawyer for Individuals: Transactions by WTR 1000, 2020. He is also listed in Asia IP's Best 50 IP Expert, 2020, recognised as a Rising Star by Managing IP: IP Stars, 2019 and one of Singapore's 70 most influential lawyers aged 40 and under by Singapore Business Review, 2016. Ren Jun was acknowledged by WTR 1000 as a "trademark connoisseur who boasts supplementary knowledge of regulatory issues in the consumer products industry." He was also commended by clients for being "very responsive to enquiries and with a keen eye for detail, he is extremely hands-on. His meticulous and in-depth approach to strategising is key to the excellent outcomes we enjoy."

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Toby Patten is a partner in Baker McKenzie's Technology and Healthcare teams in Melbourne. He joined the Firm in March 2005.

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Vivian Wu is a FenXun Partner in Baker McKenzie's Beijing office, advising US and European corporations on regulatory, compliance and FCPA-related matters in China. Ms. Wu worked at our Washington D.C. office in 2014, graduated from Harvard Law School, and is admitted to practice in New York and China.

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Kellie is is based in the Dubai office of Habib Al Mulla & Partners, a member firm of Baker & McKenzie International. An experienced technology and privacy lawyer, she has been advising local and multinational businesses and public institutions in the UAE since 2012.

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Elisabeth Dehareng joined Baker McKenzie's Brussels office in 2003 and is a partner since 2014 in the Information Technology & Communications and Intellectual Practice Groups. She was admitted to the Brussels bar in 2003. She is a member of the EMEA IP Tech Steering Committee. Elisabeth is regularly mentioned in publications such as Legal 500 and Chambers.

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Nathalja Doing is a senior associate in Baker McKenzie Amsterdam's Intellectual Property, Information Technology & Communications and Commercial practice groups. She is part of its IP and IT subgroups and the multidisciplinary Privacy Team. Nathalja has particular knowledge on various aspects of law and technology, specifically GDPR, platform laws, content regulation and IP.

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Francesca Gaudino is the Head of Baker McKenzie’s Information Technology & Communications Group in Milan. She focuses on data protection and security, advising particularly on legal issues that arise in the use of cutting edge technology. She has been recognized in Chambers Europe’s individual lawyer rankings from 2011 to 2014. Ms. Gaudino is a regular contributor on international publications such as World Data Protection Review, DataGuidance, and others. She routinely holds lectures on data privacy and security at post-graduate courses of SDA – Manager Direction School of the Milan Bocconi University and Almaweb – University of Bologna. She regularly speaks at national and international conferences and workshops on the same topics.

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Julia joined Baker McKenzie's London office as a trainee in 2005, qualifying in 2007, with a secondment to the Singapore office, and has shaped her practice to focus exclusively on regulatory matters affecting the Healthcare & Life Sciences industry.

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Els Janssens is a Counsel in Baker McKenzie Brussels office.

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Yann Padova joined Baker McKenzie as a partner in the Information Technology Group and head of the Data Protection Practice in Paris. He is internationally recognized in digital network law, personal data and regulatory law. Yann Padova has an extensive experience in data protection for 17 years and has served both as a regulator and a lawyer. In November 2017, he has been appointed “Country Leader” by the International Association of Privacy Professional (IAPP). Before joining Baker McKenzie, Yann Padova served as Commissioner with the Commission de Régulation de l’Energie (2015-2017), to which he was appointed by the President of the National Assembly due to his skills in the field of personal data. Before this, he had worked for Baker McKenzie in Paris as Senior Counsel in the Information Technologies and Communications team (2012-2015). For 6 years, he was Secretary General of the CNIL, the French data protection authority (2006-2012) where he participated in the very first rounds of negotiations of the GDPR. He began his career as an Administrator at the National Assembly (1995-2006) where he specialised in personal data laws, criminal law and criminal procedures and notably participated in the legal work that led to the transposition of the Directive 95/46 on data protection into French Law.

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Patricia Perez joined the Information Technology & Communications Department of Baker & McKenzie in Madrid in 2013. Her prior experience includes working at national law firms in the Corporate and Intellectual Property and Information Technology departments.

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Florian Tannen is a partner in the Munich office of Baker McKenzie with more than 10 years of experience. He advises on all areas of contentious and non-contentious information technology law, including internet, computer/software and in particular data privacy law. Before joining the Firm, Florian worked for two major law firms and a large US-based technology company.

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Jaspreet advises market-leading tech and healthcare companies on issues at the cutting-edge of digital health. She focuses on the development and regulation of healthcare technology and data solutions. This includes assessing how digital health solutions can comply with the legal framework for data privacy, medical research and medical devices / pharmaceuticals.

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Julie Yeni practices in the Pharmaceutical and Healthcare Industries Practice Group of Baker McKenzie in Paris.

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Flavia Amaral is a partner at Trench Rossi Watanabe. *Trench Rossi Watanabe and Baker McKenzie have executed a strategic cooperation agreement for consulting on foreign law.

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Vanina Caniza is a partner in Baker McKenzie’s Buenos Aires office and the Global Chair of the Healthcare & Life Sciences Group. She advises a range of multinational, Latin America and Argentine clients in a variety of corporate and commercial law matters, with extensive experience in corporate compliance, commercial agreements, mergers & acquisitions and regulatory advice. Vanina has extensive knowledge in the pharmaceutical, biotech and medical device sectors. She completed postgraduate courses on Biotechnology at Universidad Torcuato di Tella (Buenos Aires) and on Health Law at Universidad de Buenos Aires. She was previously the Latin America Leader of the Healthcare & Life Sciences Group and also sits on the Steering Committee of the Firm’s Latin America Corporate Compliance Group. She is currently a professor in the CEC Compliance & Ethics Certification (AAEC-UCEMA).

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Diego Ferrada has 10 years of experience working on mergers and acquisitions, including stock and asset transactions, as well as project finance transactions. He was admitted to the New York State Bar in 2007, and subsequently became a member of the New York Bar Association and the American Bar Association. Mr. Ferrada also studied Competition Law & Policy at the London School of Economics. He won the 2005 Deal of the Year award from Trade Finance for his work on HSBC Bank Plc’s multimillion-dollar export finance transaction involving the Transantiago Urban Transport System.

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Roberto Grané is a transactional and regulatory partner in Baker McKenzie’s Buenos Aires office. He has been recognized as a leading practitioner by Chambers Latin America. Clients benefit from his more than 20 years of extensive domestic and international experience. Prior to joining Baker McKenzie, Roberto served as in-house counsel to one of the major telecommunications companies in Argentina, and a law clerk with the Civil Courts of Buenos Aires. He is a professor of contract law at the Buenos Aires University and a visiting professor in several local universities.

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Carolina Pardo joined Baker McKenzie in 1994 and is a Partner of the Firm since 2008. She is currently a member of the Global Steering Committee for the Firm’s TMT industry group and of the Global Steering Committee for the Firm’s Compliance & Investigations Group. She was a member of the Global Steering Committee for the Firm’s Global Antitrust and Competition from 2016 and until 2020 and is currently a member of the Latam's Antitrust Steering Committee. She graduated as a lawyer and a specialist in International Contracts Law from Universidad de los Andes in Bogotá. She obtained a LL.M. with emphasis in International Private Law and Competition Law from the London School of Economics and Political Science. Over 25 years, she has advised major national and international clients on matters related to compliance with data protection, competition and consumer law rules. She has represented clients in investigations and submissions related to data protection and competition matters in Colombia and has successfully coordinated and prepared white paper proposals to national authorities on behalf of major industrial groups in Colombia. In 2016 Global Competition Review selected her as one of the 100 most influential women in antitrust. The last two Superintendents of Industry and Commerce have selected Carolina as a Non-Governmental Advisor to the Colombian Antitrust Regulator.

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Maria Eugenia Salazar has more than 15 years of experience and became partner in 2010. María Eugenia is very active in investment protection and international arbitration as well as in public law, in particular on telecommunications and energy. According to Chambers María Eugenia is described by market insiders and peers as a key partner very active in the dispute resolution arena, and as a "a very able lawyer." Legal 500 also recognizes María Eugenia as a key player in investment arbitration; energy and natural resources, environmental and public law. María Eugenia is a respected authority on several areas of law in Venezuela, and her expertise is regularly solicited by leading publications and organizations.

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Teresa Tovar regularly sponsors companies in proceedings before INDECOPI in matters of free competition, consumer protection, unfair competition and the elimination of bureaucratic barriers. She is a representative of business associations before the National Council of Consumer Protection of INDECOPI. Teresa is recognized in competition law by diverse prestigious international publications such as Chambers & Partners, PLC Which Lawyer? and Who's Who Legal?

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Khelin Aiken practices in the area of US Food and Drug Administration regulatory and compliance law. She leverages her deep understanding of the US Food Drug & Cosmetic Act, US Public Health Service Act and their implementing regulations along with her prior experience at the US Food and Drug Administration (FDA) to help clients develop and achieve their strategic business objectives. Khelin previously served as regulatory counsel at the FDA in the Center for Drug Evaluation and Research, in both the Office of Regulatory Policy and in the Office of New Drugs with the Therapeutic Biologics and Biosimilars Staff.

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Brian Hengesbaugh is Chair of the Firm's Global Data Privacy and Security Business Unit, a Member of the Firm's Global IP Tech Steering Committee, and a Member of the Firm's Financial Institutions' Group. Brian is listed in The Legal 500 Hall of Fame and was recognized as a Regulatory & Compliance Trailblazer by the National Law Journal. He is also listed as a Leading Lawyer for Cyber law (including data protection and privacy) in The Legal 500 and is listed in Chambers. Formerly Special Counsel to the General Counsel of the US Department of Commerce, Brian played a key role in the development and implementation of the US Government’s domestic and international policy in the area of privacy and electronic commerce. In particular, he served on the core team that negotiated the US-EU Safe Harbor Privacy Arrangement (Safe Harbor), and earned a Medal Award from the US Department of Commerce for this service. In addition, Brian participated on behalf of the United States in the development of a draft Council of Europe Treaty on Cyber Crime, and in the negotiation of a draft Hague Convention on Jurisdiction and the Recognition of Foreign Judgments. Brian has been quoted in the Wall Street Journal, New York Times, Forbes, CNET, Slate Magazine, Compliance Weekly, BNA Bloomberg, PCWorld and other news publications on global privacy and security issues.

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Theo Ling heads Baker McKenzie's Canadian Information Technology/Communications practice and is a member of the Firm's Global IP/Technology Practice Group, and Technology, Media & Telecoms and Financial Institutions Industry Groups. Theo is ranked by several legal directories, including Chambers Canada, where he is described as "a knowledgeable technology lawyer, with a practical, 'can-do' attitude who is excellent at getting things done." Named by the Financial Times as one of the Top Ten Most Innovative Lawyers in North America, Theo founded the legal industry's first global legal innovation lab focused on multidisciplinary collaboration and serves on the Firm's Global Innovation Committee.

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Christian is the head of Healthcare & Life Sciences Industry Group in Mexico, as well as a member of the Steering Committee of the North American and Latin America Healthcare Group. He has more than 17 years of experience in regulation of life sciences, pharmaceutical law and biotechnology matters, having worked in the private and public sectors and at the national and international level. For several consecutive years, Christian has led the rankings for Life Sciences both nationally (Chambers Latin America) and internationally (Chambers Global).

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Nicholas ("Nick") Merker is a member of Baker McKenzie's North America Intellectual Property & Technology Practice, which provides clients with a full suite of data privacy and cyber services. Having a ten-year background in technology as a systems, network and security engineer prior to his law career, Nick advises clients on identifying and mitigating legal risk, offering practical solutions rooted in deep understanding of the technology and new media. He is a sought-after international speaker, teacher, writer and professor on data security and privacy-related legal issues. Nick is Faculty at the International Association of Privacy Professionals where he leads global privacy trainings to executives, engineers, lawyers and managers. He also teaches a Data Security and Privacy Law course at Indiana University Robert H. McKinney School of Law.

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Cristina G. Messerschmidt is an associate in the Privacy and Security practice group based in Chicago, advising global organizations on privacy and data security compliance requirements, as well as data security incident response.

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Kamleh Nicola is a partner in Baker McKenzie's Toronto office and a member of the North America Healthcare Steering Committee. A litigator whose practice is primarily in intellectual property and dispute resolution, Kamleh has successfully navigated cases through to resolution in a manner that maximizes benefits to her clients. She can efficiently manage the complexities of litigation without losing sight of the overall case strategy, especially where the case is litigated in multiple jurisdictions. In those instances, Kamleh works collaboratively with counsel and client contacts in those jurisdictions to ensure consistency in strategic approach. Kamleh also assists life science and medical device companies to navigate the complexities of the health regulatory regime and advises corporate directors and senior management on various aspects of governance and compliance. She has been recognized in Legal Media Group's 2013 to 2020 Guides to the World's Leading Women in Business Law and the World's Leading Patent Practitioners, as well as Who's Who Legal (Patents) and IAM Patent 1000 . Kamleh is an active member of the Firm's North American Diversity and Inclusion Committee and Anti-Racism Taskforce.

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Stephen Reynolds is a member of Baker McKenzie’s North America Intellectual Property & Technology Practice, which provides clients with a full suite of data privacy and cyber services. He frequently advises clients on complex matters involving data privacy and security laws and serves on the board of directors of the International Association of Privacy Professionals (IAPP). Stephen’s expertise adds value to organizations by mitigating cyber threats through proactive preventative measures and navigating complex litigation on behalf of clients in data privacy and security. As a former computer programmer and IT analyst, Stephen is uniquely able to and routinely uses his computer background in cases involving data privacy and security, electronic discovery, social media discovery, and computer forensics. Stephen has given several presentations on data privacy and security, electronic discovery and social media discovery, and is a Certified Information Privacy Professional (CIPP/US). In addition to being a Certified Information Systems Security Professional (CISSP), Stephen teaches CISSP classes as a Direct Instructor with the (ISC)2. Additionally, Stephen teaches a course on Data Security and Privacy Law at Indiana University Robert H. McKinney School of Law.

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Harry A. Valetk is a partner in the Global Privacy and Security Practice group based in New York, advising global organizations on privacy and data security compliance requirements. He regularly supports companies in financial services, retail, pharmaceutical/ healthcare, travel/hospitality, cloud technology, and manufacturing industries. His practice is focused on delivering commercially practical advice to highly regulated companies on designing security, privacy, and technologically compliant solutions. Harry's practice routinely covers a wide range of issues on global regulatory implementation readiness for privacy laws, including GDPR, CCPA, CPRA, HIPAA, GLBA, the Children’s Online Privacy Protection Act (COPPA). He also works with companies in developing customized comprehensive incident response plans, trainings, table-top exercises, and advising senior management on liability risk mitigation. Harry puts on an insider's perspective when advising his clients building on his in-house experience as Director of MetLife’s Global Privacy Office in New York for almost seven years. In that role, he supported business lines in more than 60 countries to protect the personal data of over 90 million MetLife customers. Additionally, he led numerous strategic efforts to build out a global Privacy Risk Framework, achieve global compliance with applicable privacy and data protection laws, deploy cross-border data transfer solutions, implement global training and awareness initiatives, and manage data and cyber security incidents. Before MetLife, Harry led the video game publishing industry's privacy compliance efforts as the Director of Privacy Online for the Entertainment Software Rating Board and its COPPA Safe Harbor Seal Program. Finally, Harry served as a trial attorney for the U.S. Department of Justice, Civil Division.

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Carlos is a partner in Baker McKenzie's Information Technology and Communications Practice Group in Mexico City, and the head of the Firm's Technology, Media and Telecommunications (TMT) Industry Group in Mexico. A Certified Information Privacy Manager (CIPM) by the International Association of Privacy Professionals (IAPP), and an award winner of national accolades on digital transformation and legal innovation, Carlos is recognized by Chambers and Partners, Legal 500 and other international publications as one of the country's leading TMT lawyers. Carlos' strong specialization and multidisciplinary consultancy background (prior to joining Baker McKenzie, he led the TMT legal practice of PwC) and superior legal tech law knowledge, are the foundation of Carlos' unique vision and problem-solving skills, which allows Carlos to assist clients to identify and address corporate, commercial, technical, compliance, tax, regulatory, strategy, expansion and policy issues that arise in different phases of complex technology projects.

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