Jane Summerfield

Jane Summerfield

Partner Global Regulatory

London

+44 20 7296 2000

[email protected]

Languages

English

Jane Summerfield

Overview
Experience
Credentials
Insights and events

Jane Summerfield is Co-Head of our Life Sciences & Health Care industry sector and leads the Hogan Lovells life sciences regulatory and commercial practice in London. She advises life sciences companies on a wide range of regulatory matters, including clinical trial requirements, early access schemes, marketing authorisations, manufacturing and distribution licences, CE marking, product labelling, advertising and marketing activities, non-promotional activities, and pricing and reimbursement.

Jane also advises on commercial contractual arrangements, including consultancy, sponsorship, co-promotion, collaboration, manufacturing, distribution, services, quality and pharmacovigilance agreements.

Jane works with clients to resolve issues with UK enforcement authorities and regulatory bodies, including the Medicines and Healthcare products Regulatory Agency (MHRA), Prescription Medicines Code of Practice Authority (PMCPA), Advertising Standards Authority (ASA), and Trading Standards.

Jane combines a scientific background with deep regulatory knowledge and a commercial approach, providing "clear responses with business impact" Chambers UK.

Representative experience

Advising various multinational pharmaceutical companies on the regulatory requirements relating to marketing authorisations & manufacturing, import & wholesale dealer licences

Advising an international healthcare services provider on the regulatory requirements governing the provision of remote medical services.

Advising a UK pharmaceutical manufacturer on the regulation of the authorisation, pricing and reimbursement, and sale and advertising of medicinal products in the UK.

Advising a U.S. pharmaceutical manufacture on EU & UK SOPs covering approval of marketing materials & activities, hospitality, promotional gifts, samples & medical advisory boards

Advising an internet-based consumer goods retailer on competitor challenges to price claims and a Trading Standards challenge to its on-line ordering process for selling age restricted products.

Advising a leading soft drinks manufacturer on labelling and compositional legislation, advertising copy and defending challenges to products and advertising materials by regulatory authorities.

Advising a UK pharmaceutical company on a co-promotion agreement involving the joint promotion of a new treatment with another major pharmaceutical manufacturer.

Advising a medical device manufacturer on an innovative risk share agreement with a prime contractor supplying services to a Clinical Commissioning Group.