Institution of Civil Engineers

This Practice Note looks at the ICE Dispute Board Procedure, which the parties to a construction contract can agree to adopt as a dispute resolution procedure (whether or not the HGCRA 1996 applies). A dispute board is a panel appointed to assist in the resolution of disputes which arise under a construction contract. See Practice Note: Dispute boards—what are they and what are their advantages and disadvantages?. A dispute board aims to facilitate the swift resolution of disputes without the parties having to resort to court proceedings or arbitration. Several organisations publish rules relating to dispute boards and some contracts, including FIDIC, provide for disputes to be decided by a dispute board (see Practice Notes: FIDIC contracts 2017—Dispute Avoidance/Adjudication Boards and FIDIC contracts (pre-2017 editions)—dispute adjudication boards). The ICE Dispute Board Procedure The Institution of Civil Engineers (ICE) offers a number of dispute resolution services, and publishes standard procedures for resolving disputes, including the ICE Dispute Board Procedure. The ICE Dispute Board Procedure sets out rules for appointing a dispute board, referring a dispute, the conduct of

This Practice Note considers the election of employee representatives under the Information and Consultation of Employees Regulations 2004 (ICER 2004), SI 2004/3426. For general information on ICER 2004, see Practice Note: The Information and Consultation of Employees Regulations 2004. For information on the election of employee representatives for the purposes of European Works Councils, see Practice Note: European works councils. For checklist information on electing employee representatives under ICER 2004, see: • Checklist for electing or appointing negotiating representatives • Checklist for electing or appointing I+C representatives See also Precedents: • Election rules—electing employee representatives • Nomination form—employee representative candidates • Application form—employee representative candidates • Letter—enclosing ballot paper for election of employee representatives • Proxy form—voting for employee representatives • Voting form—employee representatives Types of employee representatives ICER 2004 creates three different types of employee representative: • employees' representatives, used in the pre-negotiation stages, who are not defined in ICER 2004 but government guidance suggests that the intention is to allow employees to request information or challenge matters through an intermediary such

The International Council on Harmonisation (ICH) announced the adoption of its E2D(R1) guideline, which aims to standardise terminology related to adverse events and streamline procedures and timelines for collecting and reporting post-approval safety data for medicinal products. Further to public consultation in February 2024 which resulted in only minor revisions to the draft guideline, the revisions update the original guideline adopted in 2003 to account for new sources of post-approval safety information such as through social media, market research programs, and patient support and assistance programs. The revised guideline includes: clarification and standardisation of key terms such as adverse events, adverse drug reactions, serious adverse events/adverse drug reactions, and unexpected adverse events/adverse drug reactions; reporting timeframes, such as that ICSRs that fulfil regional or local criteria for expedited reporting should be submitted no later than 15 calendar days after day zero; new qualifier language in Section 2.2 regarding the minimum criteria for Individual Case Safety Reports (ICSRs); new language that clarifies the definition of a digital platform specifying that 'digital platforms include, but are not limited to, social media, websites, internet forums, chat rooms, mobile health technologies, and software applications (apps)'; and another example of an organized data collection system (ODCS) to include 'an activity where an MAH monitors and analyses user communications on a social media site, often referred to as social listening or digital listening, is an example of ODCS'.

The International Council for Harmonisation (ICH) has adopted its M15 Guideline: General Principles for Model-Informed Drug Development (MIDD) at Step 4 of the harmonisation process, with the European Medicines Agency (EMA) publishing the Step 5 guideline and associated scientific guideline. The guideline will now move to the implementation phase (Step 5). Although ICH has previously issued guidelines that address specific aspects of MIDD, there has been no overarching guideline setting out general principles. This has contributed to uncertainty about the global regulatory acceptability of MIDD and has led to variation in the quality of MIDD applications and documentation in regulatory submissions, particularly where novel methods or applications are involved that are not addressed by existing, topic-specific ICH guidelines. The ICH M15 Guideline sets out general principles and good practices for the use of MIDD and is intended to harmonise regulatory expectations relating to documentation standards, model development, the data used in analyses, and model assessment and application.

The International Council for Harmonisation (ICH) has adopted guideline E11A on 21 August 2024, which establishes a harmonised framework for extrapolating drug development data from adult clinical trials to paediatric populations, and is now ready for regulators to implement in their local jurisdictions. The guideline aims to align terminology and harmonise approaches related to paediatric extrapolation worldwide in an effort to expedite the approval of new paediatric drugs addressing what the ICH E11A concept paper identified as a gap of seven to ten years between the approval of a drug for adults and the inclusion of paediatric information in product labelling because of these differing extrapolation principles. It details the development of a paediatric extrapolation concept and the development of a paediatric extrapolation plan and discusses statistical and modelling methods that can be used to support these. The guideline will come into force from 25 January 2025.

The International Council for Harmonisation (ICH) has adopted its M14 guideline. The ICH M14 guideline establishes internationally harmonised principles for the planning, design, analysis and reporting of non-interventional pharmacoepidemiological studies that use real-world data (RWD) to assess the safety of medicines. It aims to improve the reliability and regulatory acceptance of such studies by providing a structured framework that includes feasibility assessments, protocol development, data management and statistical analysis. The guideline emphasises the importance of fit-for-use data, robust study design and early engagement with regulators to ensure that evidence generated is adequate for post-marketing safety evaluations. It also outlines considerations for bias, confounding and validation of key variables and encourages transparency through public registration and dissemination of study findings.

The International Council for Harmonisation (ICH) Assembly has reported progress on guideline development, including approval of concept papers for two new guidelines: E23, which addresses the use of real-world evidence in regulatory decision-making and M18, which provides a framework for assessing comparative efficacy studies in biosimilar development. Updates from working groups highlighted milestones in both new guidelines and revisions to existing ones, reflecting ICH’s commitment to harmonisation and scientific rigour.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has adopted a new version of its Guideline for Good Clinical Practice E6(R3). Endorsed by the ICH Assembly on 06 January 2025, the updated guideline introduces significant changes to various aspects of clinical trial conduct. Key revisions include enhanced requirements for quality management, risk assessment, and computerised systems. The guideline also features new sections on data life cycle elements and data governance, reflecting the evolving landscape of clinical research and data management practices.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has published a reflection paper on European Medicines Agency (EMA) efforts to establish a sustainable framework enabling better integration of real-world data (RWD) and real-world evidence (RWE) into regulatory decisions, focused on the effectiveness of medicines. The reflection paper discusses the convergence of terminology for RWD and RWE, the format for protocols and reports of study results submitted to regulatory agencies throughout the lifecycle of medicinal products, and reviews the important considerations, and regulatory guidance and resources related to RWD and RWE. The EMA has also published a report on the regulatory-led studies using RWD to support EU regulatory decisions from September 2021 to February 2023. During this period, 40 studies were completed or ongoing, of which 13 studies were used to inform vaccine safety and effectiveness, and 60 new research topics were identified.

The International Council for Harmonisation (ICH) has announced the adoption and publication of Annex 2 of the ICH E6(R3) Guideline for Good Clinical Practice (GCP), completing the revision of the international GCP standard. Annex 2 provides additional guidance for decentralised and pragmatic clinical trials and the use of real-world data. ICH has consolidated the Principles, Annex 1 and Annex 2 into a single ICH E6(R3) guideline, which it said should be read as a unified document. Annex 2 will also remain available as a standalone document until the end of 2026 to support regulatory authorities that had already begun implementing the Principles and Annex 1 before its publication.

The International Council for Harmonisation (ICH) has adopted its M12 guidance, which promotes a harmonised approach in conducting and interpreting enzyme- or transporter-mediated in vitro and clinical drug-drug interaction (DDI) studies during the development of an investigational therapeutic drug. Step 4 means the document is ready for regulators to adopt in their jurisdictions. The ICH M12 DDI guidance was released for public consultation in May 2022 and received a large response from pharma wanting more clarity on the timing of DDI studies as well as the scope of these studies. The guideline 'provides general recommendations for DDI evaluation due to the many possible combinations of drugs, patient populations and therapeutic contexts, but also contains specific recommendations in well-established areas.' ICH also released a supporting question and answer document to clarify points raised about drug interaction assessments as well as a training presentation to help with the guide’s implementation. Currently, the jurisdictional variation in conducting these studies lead to increased drug development costs and delays patient access to new drugs.