Mandi Jacobson
Partner Global Regulatory
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Overview
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Experience
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Credentials
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Insights and events
Chambers Asia Pacific 2020"very pragmatic, efficient and commercial advice, whatever the problem or the query might be."
Mandi Jacobson's practice includes both advisory and contentious matters across a variety of sectors, including the life sciences (pharmaceuticals and medical devices), food and beverage, cosmetics, industrial chemicals, and automotive sectors.
Her practice focuses primarily on product liability (advice and litigation) and the regulation of a broad range of products in Australia. Mandi acts for clients in relation to regulatory compliance, consumer law, therapeutic goods (medical devices including PPE and medicines) registrations and listings, product recalls, compliance with voluntary and mandatory standards and orders, product liability, privacy issues, and advertising/labelling.
Mandi is Co-Chair of the Medical Technology Association of Australia’s Privacy Working Group.
Chambers Asia Pacific 2023 says - Mandi Jacobson of Hogan Lovells heads the firm's team from the Sydney office and is especially well regarded for her knowledge of the life sciences regulatory landscape, which she interprets for clients from the pharmaceutical, medical device and other industries.
Chambers Asia Pacific 2020"extremely high level of knowledge across different areas of the field"
Representative experience
Advising clients in relation to understanding and complying with the Australian Consumer Law.
Advising clients in relation to understanding and complying with voluntary and mandatory standards and orders.
Advising clients in relation to defective products.
Assisting with product recalls and product recall strategies.
Assisting clients with crisis management and communications.
Advising clients in relation to communications with Commonwealth and state regulators, including the Australian Competition and Consumer Commission (ACCC).
Assisting with compliance in relation to advertising/ labelling in Australia.
Defending clients against product lability claims.
Advising clients in relation to understanding and complying with therapeutic goods legislation (Therapeutic Goods Act and associated regulations and codes).
Assisting clients with product registrations.
Advising clients in relation to proposed cancellations or suspensions on the Australian Register of Therapeutic Goods (ARTG).
Advising clients in relation to unsafe therapeutic goods.
Advising clients in relation to reporting requirements and audits.
Assisting with compliance in relation to advertising/labelling in Australia.
Assisting with recalls and recall strategies, including liaising with the Therapeutic Goods Administration (TGA).
Assisting clients with crisis management and communications.
Defending companies in relation to claims brought by hospitals.
Advising clients in relation to understanding and complying with the Australia New Zealand Food Standards Code.
Advising clients in relation to understanding and complying with the Industrial Chemicals Act.
Contentious regulatory matters with the Therapeutic Goods Administration, the Australian Consumer and Competition Commission, the Office of the Australian Information Commissioner.
Product liability.
Local and international product standards.
Advertising and promotion of medicines, medical devices, consumer goods.
Registrations and listings of therapeutic goods on the ARTG; product cancellations, suspensions and recalls.
Cell, Tissue and Gene Therapies.
Clinical trials and patient compensation.
Pricing & reimbursement.
Privacy, data protection, cyber breaches and mandatory reporting requirements.
Import and export requirements and quarantine laws.
Customs and tariffs.
Commercial litigation and dispute resolution.
White collar investigations in Australia and across borders.
Health Care Complaints Committee matters.
Drafting of manufacturing and distribution agreements.
Compliance and regulatory matters across sectors including therapeutic goods, food and beverages, cosmetics, technology and e-commerce, electrical products, automobiles, drones, defence products.
Investigations and requests for information with the Therapeutic Goods Administration, Australian Consumer and Competition Commission, and Office of the Australian Information Commissioner.
Investigations and requests for information with the Australian Border Force, Department of Defence, and state Fair Trading departments.
Credentials
- Graduate Diploma of Health Law, University of Sydney, with honors, 2010
- Bachelor of Arts, Macquarie University, 2004
- Bachelor of Laws, Macquarie University, 2004
- Supreme Court of New South Wales
- Law Society of NSW
- Medical Technology Association of Australia (MTAA)