Arnold & Porter’s Future Pharma Forum invites you to a complimentary regulatory seminar aimed at junior lawyers and new joiners in the UK/EU life sciences industry. We will provide a comprehensive introduction to key EU regulatory law topics from an in-house practitioner’s perspective and touch on the implications of Brexit.

Topics

  • Overview of the EU pharmaceutical law framework
  • Clinical trials, unlicensed supply and compassionate use
  • Obtaining marketing authorisations
  • Incentives: regulatory data protection, marketing protection, orphan market exclusivity and paediatric rewards
  • Pharmacovigilance
  • Advertising and promotion of medicinal products
  • Pricing and reimbursement in the UK
  • Supply chains

Who is it relevant for?

The Future Pharma Forum is a group established to provide training and networking opportunities for junior and mid-level lawyers in the life sciences industry. We conduct seminars and events aimed at junior and mid-level lawyers up to around 8 years PQE. There are no formal entry or membership requirements— please feel free to pass this to colleagues who might be interested in attending.

More information is on the website, and you can sign up here.

In July, we reported that the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) had announced a joint proposal to promote the use of innovative approaches to paediatric drug development. We noted that the EMA expected to publish a Reflection Paper setting out a systematic approach to extrapolation of paediatric data by the end of the year. This has now been published.

Continue Reading EMA Reflection Paper on paediatric extrapolation

Last week, the European Commission published its ten-year report on the implementation of the Paediatric Regulation 1901/2006 (together with a useful Questions & Answers document). The report provides an account of the Regulation’s achievements, both in public health and economic terms, and an analysis on the extent to which its objectives and aims have been met.

It concludes that positive advances in the development of medicines for children could not have been achieved without specific EU legislation, and that 260 new medicines (new marketing authorisations and new indications) have been authorised as a result. However, certain problem areas have been identified, in particular in relation to the interplay between the Paediatric Regulation and the Orphan Medicinal Products Regulation 141/2000. The report does not set out any proposals for amendments to the Regulation, but states it will be for the next Commission, after 2019, to implement any necessary changes.

Continue Reading Ten-year report on Paediatric Regulation published

On 6 July 2017, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) announced a joint proposal to promote the use of innovative approaches to paediatric drug development. The proposal focuses on paediatric Gaucher disease, but the intention is for the principles underlying the so-called “strategic collaborative approach” to be extended to other areas of development for rare paediatric diseases.

The collaborative approach was considered necessary as, given the limited number of patients with Gaucher disease, identifying multiple candidate target products, and running multiple clinical trials, may actually hinder the development of an effective treatment. Continue Reading Innovative approaches to paediatric drug development