Jurisdiction(s):
United Kingdom

Key definition

IA definition

What does IA mean? In practice, IA is the common shorthand for the Investment Association, the UK trade body for investment managers. It is not defined in legislation or case law; the term is a widely used industry label. The IA issues influential, non‑binding guidance and policy statements used by legal advisers and listed companies, including the IA Principles of Remuneration and annual Shareholder Priorities, and it operates the Institutional Voting Information Service (IVIS), which produces red/amber/green voting research on governance, pay and capital management. IA materials are frequently consulted in UK corporate governance, executive remuneration, equity capital markets (for example placings and buy‑backs)...

Paediatric Medicines: EU and post‑Brexit UK regimes on PIPs, waivers, deferrals, incentives (paediatric extensions, PUMA), enforcement and reforms; plus US overview and international standards (ICH E11A, WHO)

Published by a LexisNexis Life Sciences expert

Practice notes

Also produced in partnership with contributions from Marylis Clerc of Bird & Bird and Sapna Palla of White & Case LLP.

What are paediatric medicines and why do we need them?

Paediatric medicines are medicinal products intended for children from birth up to, but not including, 18 years of age.

For decades, research and development in this field was minimal. Numerous medicines were neither studied nor authorised for paediatric Use, leaving clinicians to modify adult formulations and doses using their own judgement. Unsurprisingly, such widespread off‑label prescribing brought a higher risk of poor efficacy and adverse reactions in children. According to a report by the European Medicines Agency (EMA), despite limited available data, harm did occur and was frequently underreported.

Several factors explain the lack of paediatric R&D, including the view that enrolling children in clinical trials was unethical. Creating medicines for younger patients is also far more challenging than for adults, as children are not a uniform group and have varied needs alongside distinct biological and physiological profiles. This inevitably requires additional...

To view the latest version of this document and thousands of others like it, sign-in with LexisNexis or register for a free trial.

Tine Carmeliet

A&O Shearman

Tine heads A&O Shearman’s Belgian life sciences team. She specializes in life sciences patents litigation and advises clients on regulatory issues and commercial transactions in the life science sector. Her litigation experience includes both representing clients before the Belgian and European courts and assisting clients with multi-jurisdictional proceedings. She advices multinational companies and start-ups as well as research institutes in the pharmaceutical, biotech and medical devices sectors on a variety of complex matters, including clinical trials, product approvals, regulatory incentives, market access, promotion and advertising, post-market obligations, MDR and IVDR, digital health solutions, artificial intelligence, real world data and transparency regulations. She regularly assists clients with drafting and negotiating high value IP licenses, R&D collaborations, tech transfer and spin-out deals and has particular expertise with cell and gene therapy products. In addition, Tine has extensive experience advising on agro(bio)tech and food and feed...

Eline D’Joos

A&O Shearman

Eline is a junior associate in the IP department of Allen & Overy Belgium, and a member of the Belgian life sciences practice. She focusses on IP, life sciences regulatory law and data protection, and assists clients both in non-litigious and litigious matters in these areas. She has expertise in advising on biosimilars, orphan drugs, Belgian supplementary protection certificates and the regulatory approval pathway to bring vaccines to market. She has also assisted with mergers and acquisitions of life sciences companies, as well as patent infringement proceedings and preliminary injunctions in relation to strategic drugs....

Rafi Allos

A&O Shearman

Rafi is a Partner in the IP Litigation practice in London. Rafi specialises in contentious life sciences patents work and advising clients on regulatory issues in the life sciences sector. Rafi's patent litigation experience includes both representing clients in U.K. proceedings and assisting clients with multi-jurisdictional proceedings and preparation for potential litigation. In addition, Rafi has a particular interest in the impact of life sciences regulatory issues on patent litigation.Rafi has spoken on life sciences regulatory matters at the Pharmaceutical Law Academy in Cambridge from 2014 to 2017. He has been recognised since 2017 as a “rising star” in the Patents section of Managing Intellectual Property's IP Stars and as a Next Generation Lawyer / Rising Star in Legal 500 (both in Life Sciences and Healthcare and in Patents). Rafi was also awarded a European Rising Star Award in the Life Sciences and UK...

Dr Jacqueline Bore

A&O Shearman

Jacqueline is a senior lawyer with many years’ experience in advising companies in the life sciences sector on the challenges they face in developing and bringing new medicines and medical devices to the market. She has advised clients on the regulatory pathway for medicines and medical devices in Europe, in particular advising on: Clinical trials, including transparency issues Paediatric investigation plans, Marketing authorisations, Orphan medicinal products, Manufacturing and wholesale distribution authorisations, Supply chain issues including novel direct to patient solutions, Parallel trade Advertising and promotion Relations with healthcare professionals, including bribery and corruption Pricing and market access, including NICE submissions and appeals Product liability, including managing substantial multiparty actions. Jacqueline has advised on a number of judicial reviews challenging regulatory decisions of both MHRA and the EMA and has defended product liability claims in the House of Lords, Supreme Court and the Court of...

Web page updated on 28/05/2026

Popular documents

Using the Judicial College Guidelines to assess general damages in personal injury claims

When evaluating a general damages claim, the practitioner ought initially to refer to the Judicial College Guidelines (JCG)...

Tomlin orders in England and Wales: CPR guidance on drafting, confidentiality, approval, variation, enforcement, limitation, CCA issues, court-specific requirements, sample wording and precedents

This Practice Note This Practice Note reviews mechanisms used in settling litigation. A Tomlin order consists of a consent order paired with a schedule. It operates to stay proceedings on terms that have been agreed. The provisions contained in the schedule may remain confidential. This Practice Note describes the scope of confidentiality attaching to the schedule and sets out how it differs from a standard consent order. Sample wording for a Tomlin order is included, alongside links to precedents, as well as guidance on court approval. It also addresses varying, setting aside and enforcing a Tomlin order, including the considerations the court will take into account when handling applications for each. Further guidance is provided on interpreting and applying the relevant provisions of the CPR; however, some courts and divisions impose very specific requirements for both drafting and approval, and for approaching the schedule and confidentiality issues. Accordingly, you must consider the particular rules and court guide provisions in the forum where your claim is proceeding when drawing up the Tomlin order...

Precedent: Deed of Surrender of Lease with Optional Premium, Settlement and Release, Landlord, Mortgagee and Guarantor Consents, Reimbursement and HM Land Registry Provisions (England and Wales)

Date [ date ] Parties [ name of Landlord ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Landlord) [ name of Tenant ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Tenant) [ [ name of Guarantor ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Guarantor) ] [ [ name of Mortgagee ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Mortgagee) ] Definitions Within this Deed, the terms below shall be interpreted as follows: [ Annual Rent • the annual sum reserved under the Lease; ] [ Insurance Rent • the Tenant’s share of the Landlord’s costs of insuring the Property (as set out in the Lease); ] Lease • the lease of the Property dated [ date ], entered into between (1) [ the Landlord OR [ name ...

Precedent Statutory Declaration: Standard Wording under the Statutory Declarations Act 1835

I, [ name ], of [ address ], solemnly and sincerely state that: [ Matters to be verified, set out in numbered paragraphs ] I make this solemn statement in good conscience, believing it to be true, and pursuant to the provisions of the Statutory Declarations Act 1835. DECLARED at [ details ] this [ day ] day of [ month and year ] Before me ................................................................................ [ signature of the person before whom the declaration is made ] A [ commissioner for oaths OR [ solicitor OR [ insert other qualification ] ] authorised to administer oaths ]...