B03. The Privacy Act in Australia: A summary of your obligations and reporting requirements

Tracks
Clinical Research
Thursday, June 13, 2024
11:15 AM - 12:15 PM
Parkside 2

Chair & Speakers

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Mandi Jacobson
Partner
Hogan Lovells (Australia)

Chair: The Privacy Act in Australia: A summary of your obligations and reporting requirements

Abstract

The team will discuss how to effectively communicate with the TGA and FDA on a range of matters including pre-market and post-market matters, inspections, audits and contentious regulatory matters.

Biography

Mandi is a Partner at Hogan Lovells Australia, a global law firm specialising in the intersection of regulation and government. Mandi advises pharmaceutical and medical device companies in regulatory matters, contentious regulatory matters against regulators, pricing and reimbursement, privacy and data protection and litigation. Mandi and her team advise clients in relation to the collection, use and transfer of personal and sensitive information, and provide assistance where data breaches have occurred (including with regards to mandatory reporting obligations to regulators). Mandi also co-chairs the Medical Technology Association of Australia’s Privacy Working Group.
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Lisa Lu
Digital Marketing Specialist
Cardinal Health Anz

The Privacy Act in Australia: A summary of your obligations and reporting requirements

Biography

Lisa Lu is the Digital Marketing Specialist for Cardinal Health ANZ, with a wealth of experience in shaping and driving digital marketing strategies and campaigns. Over the past decade, Lisa has been instrumental in guiding businesses towards enhancing customer experiences, driving revenue growth, boosting engagement, and exploring new revenue streams. In her role, she places a strong emphasis on data privacy, ensuring that marketing efforts align with user privacy regulations and adhere to industry standards and guidelines set forth by the TGA and MTAA.
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Angell Zhang
Senior Associate,
Hogan Lovells

The Privacy Act in Australia: A summary of your obligations and reporting requirements

Biography

Angell advises clients across a variety of sectors, including the medical device and pharmaceutical sectors, technology, e-commerce, agricultural and veterinary sectors. Angell regularly advises clients on product regulation, therapeutic goods regulation, import and export requirements, consumer law, product liability, advertising and labelling requirements. She also assists clients develop global compliance strategies to respond to investigations initiated by regulators, including the TGA and ACCC. Angell also develops global privacy and cybersecurity strategies and international transfer strategies for a range of major international and domestic companies, and advises clients on a range of privacy and cybersecurity issues.
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Mike Heyl
Partner
Hogan Lovells (Australia)

The Privacy Act in Australia: A summary of your obligations and reporting requirements

Biography

Mike Heyl helps medical device companies navigate myriad regulatory and business matters. He guides clients through U.S. Food and Drug Administration (FDA) regulations, requirements, and compliance issues. These issues include FDA's Quality System Regulation (QSR); adverse event reporting; recall reporting requirements; FDA inspections and enforcement actions, such as Warning Letters; defense strategies; and corrective and remedial action plans. He represents large multinational corporations facing FDA and criminal enforcement, and helps small startups develop and implement postmarket compliance programs. Because he understands FDA's requirements for importing and exporting medical devices, Mike is frequently called on to negotiate the release of detained goods being imported to the United States.
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