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Sarah Cowlishaw is an associate in the London Life Sciences group who joined the firm as a trainee solicitor in 2009.
Ms. Cowlishaw’s practice focuses on life sciences regulatory and commercial law for pharmaceutical, medical device, food, and consumer products. Her advice on general regulatory matters includes borderline determinations, food classifications, adverse event and other reporting obligations, manufacturing controls, and labeling and promotion. On the commercial side, she advises on the full range of agreements that span the product life-cycle in the life sciences sector.
Her expertise includes clinical trial agreements, manufacturing and supply agreements, distribution and other marketing agreements and regulatory services agreements. She also regularly advises on regulatory aspects of corporate/commercial transactions, particularly regulatory due diligence.
- Advising pharmaceutical and medical device companies on the regulatory status of borderline products.
- Advising pharmaceutical and medical device companies on compliance with applicable marketing laws and codes of practice.
- Regulatory and commercial due diligence for pharmaceutical, medical device and food companies.
- Negotiation and review of life sciences commercial arrangements, including clinical trial agreements, wholesaler arrangements and pharmaceutical manufacturing and supply contracts.
- Advising food/cosmetic clients on product claims and ingredient reviews.
- Co-ordinating international projects on advertising/promotion and clinical research.
Pro Bono
- Advising the Restoration of Appearance and Function Trust (RAFT) on the classification of a wound healing product containing human blood derivatives.
- Assisting in a pro-bono project aimed at improving regulatory systems for clinical trials of drugs and vaccines for neglected diseases in developing countries.
Previous Experience
- Secondment to the in-house legal department of a multinational pharmaceutical company.
- Secondment to the in-house legal department of an international pharmaceutical company, based in Germany.
May 7, 2018, Covington Digital Health
On April 26, Commissioner Gottlieb addressed the agency’s progress on FDA’s Digital Health Innovation Action Plan and announced several additional steps the agency is taking to advance the potential benefits of digital health. Here is a recap of the key updates: (1) Launch of New FDA Program to Apply Digital Health to Drugs As our...… Continue Reading
March 9, 2018, Covington Digital Health
On March 6, 2018, CMS announced the MyHealthEData initiative, which aims to give patients easier access to and control over their medical records. Announcing the initiative, CMS Administrator Seema Verma laid out a future where individuals will have access to their health data wherever they go and be able to share data with the push...… Continue Reading
February 26, 2018, Covington Digital Health
Inflection Point for IoT In a relatively short amount of time, the adoption of the Internet of Things (IoT) and its applications— from smart cars to the myriad of interconnected sensors in the General Service Administration building reminiscent of HAL 9000 from 2001: A Space Odyssey— has rapidly proliferated, providing significant opportunities and benefits. ...
February 21, 2018, Covington Digital Health
As 2018 gets underway, EHR vendors and users continue to face challenges and uncertainty. There are three legal and regulatory issues in particular that we think are important to watch over the next 10 months: Moving to the 2015 Edition Certification Criteria. Although CMS will not require hospitals or eligible professionals to use 2015 CEHRT...… Continue ...
February 13, 2018, Covington Digital Health
On February 1, 2018, Covington’s Digital Health team hosted a webinar examining U.S. and EU regulatory issues for digital health associated with pharmaceuticals. Here are some key takeaways from that webinar: Neela Paykel from Proteus Digital Health, noted that “you need to think outside the box for how to engage, whether you’re a pharma company...… Continue ...
December 21, 2017, Covington Digital Health
On December 8, FDA addressed the agency’s evolving approach to digital health by issuing two new draft guidance documents: “Clinical and Patient Decision Support Software” (the “CDS Draft Guidance”) and “Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act” (the “Software Policies Draft Guidance”). These draft ...
December 19, 2017, Covington Digital Health
On November 14, lawyers from Teva Pharmaceuticals and Covington & Burling discussed digital health innovation from a medical device regulation perspective in the U.S. and the EU. The presentation by Rachel Turow, Executive Counsel – Regulatory Law, Teva Pharmaceuticals, and Grant Castle, Scott Danzis, Sarah Cowlishaw, and Christina Kuhn of Covington, covered ...
December 15, 2017, Covington Digital Health
In this bonus edition of our checkup series, Covington’s global cross-practice Digital Health team considers some additional key questions about product liability and insurance coverage that companies across the life sciences and technology sectors should be asking as they seek to fit together the regulatory and commercial pieces of the complex digital health ...
December 5, 2017, Covington Digital Health
In the third installment of our series, Covington’s global cross-practice Digital Health team considers some additional key questions about Artificial Intelligence (AI), data privacy, and cybersecurity that companies across the life sciences and technology sectors should be asking to address the regulatory and commercial pieces of the complex digital health ...
September 26, 2017, Covington Digital Health
In the second of a three-part series, Covington’s global cross-practice Digital Health team considers some additional key questions that companies across the life sciences, technology, and communications industries should be asking as they seek to fit together the regulatory and commercial pieces of the complex digital health puzzle. Key Commercial Questions ...
August 29, 2017, Covington Digital Health
In the first of a three-part series, Covington’s global cross-practice Digital Health team answers key questions that companies across the life sciences, technology, and communications industries should be asking as they seek to fit together the regulatory and commercial pieces of the complex digital health puzzle. Key Regulatory Questions About Digital Health ...
August 9, 2017, Covington Digital Health
On 28 June 2017, Advocate General Sanchez-Bordona (AG) presented his opinion in case C-329/16 Syndicat national de l’industrie des technologies médicales and Philips France following a request for preliminary ruling from the Conseil d’État (France) to the Court of Justice of the European Union (CJEU) concerning the laws governing the classification of software ...
March 17, 2017
LONDON—Covington advised AstraZeneca on its strategic collaboration with Circassia Pharmaceuticals plc, a respiratory biopharmaceutical company, for the development and commercialisation of Tudorza and Duaklir* in the U.S. Tudorza and Duaklir are inhaled respiratory medicines for the treatment of chronic obstructive pulmonary disease (COPD). Tudorza was ...
October 21, 2016
WASHINGTON—Covington represented India-based Piramal Enterprises and its wholly owned Critical Care subsidiary in the UK in the acquisition of five anesthesia and pain management injectable products from Janssen Pharmaceutica NV, in an all cash deal for an upfront consideration of US$155 million, and up to an additional US$20 million. The products to be acquired ...
July 12, 2016, Inside Medical Devices
The UK recently voted to leave the European Union in an advisory referendum. The impact of Brexit on medical devices regulation in the medium-to-long term will very much depend on the form a post-Brexit UK will take, the relationship that the UK chooses to have with the EU, and indeed the relationship that the EU...… Continue Reading
July 11, 2016, Covington Alert
The UK recently voted to leave the European Union in an advisory referendum. The impact of Brexit on medical devices regulation in the medium-to-long term will very much depend on the form a post-Brexit UK will take, the relationship that the UK chooses to have with the EU, and indeed the relationship that the EU is willing to accept. That will not become clear ...
June 12, 2015, Inside EU Life Sciences
The European Medicines Agency (EMA) has recently published for public consultation its draft guideline on clinical development of fixed combination medicinal products (Draft Guideline), which is intended to replace CHMP/EWP/240/95 Rev. 1 (Existing Guideline). The Draft Guideline applies to fixed combination medicinal products containing two or more active ...
February 27, 2015
LONDON, February 27, 2015 — Covington advised Heptares Therapeutics Limited on its announced sale to Sosei Group, a Tokyo-listed Japanese biopharmaceutical company with operations in Japan and the UK. Consideration consisted of $180 million cash at closing and up to an additional $220 million contingent upon the successful progression of Heptares’ pipeline and ...
August 7, 2014
LONDON, 7 August, 2014 — Covington advised Ergomed plc, an international clinical research business, on its flotation on the AIM market of the London Stock Exchange, an associated fundraising and its simultaneous acquisition of PrimeVigilance Limited, a leading provider of pharmacovigilance and medical information services. Ergomed ‘s market capitalisation on ...
August 5, 2014
LONDON, 5 August, 2014 — Covington & Burling advised Illumina on its partnership with Genomics England to provide infrastructure and expertise for a four-year project that aims to make the UK the world leader in genetic research into cancer and rare diseases, through funding research to decode 100,000 human genomes - a patient's personal DNA code. The deal is ...
December 5, 2013, Inside EU Life Sciences
On 25 November 2013, the European Commission published an Implementing Decision containing guidelines to assist responsible persons comply with their regulatory obligations under the EU Cosmetics Regulation (EC) No 1223/2009 (Cosmetics Regulation). The guidelines provide clarity on Annex I of the Cosmetics Regulation, which sets out the minimum requirements for ...
November 29, 2013, CovBrands
On 25 November 2013, the European Commission published an Implementing Decision containing guidelines to assist responsible persons to comply with their regulatory obligations under the EU Cosmetics Regulation (EC) No 1223/2009 (Cosmetics Regulation). The guidelines provide clarity on Annex I of the Cosmetics Regulation, which sets out the minimum requirements ...
November 1, 2013, Inside Medical Devices
The UK National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending tightening standards for hip replacement devices. If adopted, the tougher standards could force the National Health Service (NHS) to stop using a significant number of existing devices, with obvious impacts on manufacturers of these products. The proposed ...
June 12, 2013, Inside EU Life Sciences
On May 30, 2013, Advocate General Sharpston delivered an opinion on a request for a preliminary ruling from the Finnish national courts concerning the laws governing reclassification of medical devices (Advocate General: Opinion, Case C-109/12). The Advocate General’s opinion does not bind the Court of Justice of the European Union (CJEU). However, in the ...
June 11, 2013, Inside Medical Devices
On May 30, 2013, Advocate General Sharpston delivered an opinion on a request for a preliminary ruling from the Finnish national courts concerning the laws governing reclassification of medical devices (Advocate General: Opinion, Case C-109/12). The Advocate General’s opinion does not bind the Court of Justice of the European Union (CJEU). However, in the ...
April 16, 2013, Inside Medical Devices
Commission Regulation (EU) 207/2012 on electronic instructions for use of medical devices (the Regulation) came into force in the EU last month. The Regulation allows manufacturers of certain types of medical devices and accessories to replace paper form instructions of use with an electronic substitute. It aims to reduce environmental burden and improve the ...
What’s in a Name?
September 5, 2012, Inside EU Life Sciences
Article originally published in European Pharmaceutical Contractor, September 2012 Although at first sight the rules that govern the distinction between medical devices and medicines in the EU allow for a direct and systematic approach, borderline determinations are, in practice, often difficult and the rules lack logical rigour The European Commission is ...