home > news > detailed info

Navigating the new Clinical Trial Regulation with DIA


For those stakeholders involved with clinical trials in Europe, the new Clinical Trial Regulation to be introduced in 2019 will have a dramatic impact. The aim of the change in regulation is to increase the efficiency of all trials in Europe, as well as promoting research while avoiding the duplication of clinical trials.

This will mean increased transparency of trial information and the introduction of consistent rules for conducting clinical trials. The benefits are plain to see but the implementation, for those involved, will be complicated – especially as the deadline rapidly approaches.

DIA’s Clinical Trial Regulation event, held on the 5-6 December in London, will see leaders from the pharmaceutical industry, representatives from CROs and regulatory affairs professionals convening to plot a path through the incoming changes to the regulatory environment.

The workshop aims to give stakeholders the chance to exchange information, providing practical solutions to any issues that may have arisen and allowing for collaborative discussions across lectures, panel discussions and interactive sessions.

In particular, the objectives of the workshop are to:

  • Understand the new requirements along with the practical and operational considerations for implementation by authorities and clinical trial sponsors
  • Identify the key challenges and opportunities of the new requirements and policies
  • Leverage insights on how companies and research institutions are fine-tuning and optimising processes to meet the requirements of the Clinical Trials Regulation
  • Exchange views between regulators, clinical trial sponsors, patients, and other stakeholders

The key topics that will be covered will be:

  • Member States preparedness for the regulation, including plans for co-operation between agencies and ethics committees and coordinated assessment
  • Development of the EU clinical trials portal and database
  • Considerations for the preparation of applications and notifications by sponsors
  • Impact of new requirements for disclosure and transparency of data from clinical trials 
To gain a better handle on what to expect from the event, spoke to Elke Stahl, CTFG co-chair, Clinical Trial Unit, Federal Institute for Drugs and Medical Devices (BfArM), Germany, as well as sitting on the Programme Committee for DIA’s workshop.

Stahl will be speaking at the event and began by giving an overview of what she would be discussing:

“I will cover the preparedness of the EU member states. For instance, how ready are the member states for certain key topics, like the reorganisation of the cooperation between NCAs and ethics committees; if you need a national IT system; and if your national laws have to be revised and updated.

“We have been tracking this for a couple of years already and two-thirds of the member states are going to have pilots, or have already been running them for a year or so; those currently organising them have quite a lot of experience with these pilots, meaning they have experience of cooperation between NCA and ethics committees for mono-national decision-making.”

In terms of the wider discussions that will occur at the event, Stahl noted:

“There are other sessions concerned about the status of the EU portal and database. There will be some experiences from stakeholders on the current trials of this, and we will also discuss how to build a user-friendly system to work with it when it goes live. We have an audit next year and then, after, there’s still half a year for co-development. I think this topic will bring up some interesting discussions and we can work to together to identify what will be the impact.

“A major discussion will be the challenges of the implementation from the different stakeholders and this will be coupled with some pre-defined questions, sure, but will also provide an opportunity to take up questions from the audience. This will be more like an exchange, to discover what the areas of interest are for the stakeholders”.

When asked about what topics or presentations Stahl was looking forward to personally, she replied:

“As a regulator, I am always interested in how the sponsors are getting on – what their impressions of the guidelines are and what the challenges are for them, in order to learn from each other. In regards to the portal, we are not so far apart, such as in safety. As well as this, the joint session on transparency and how the sponsors have addressed these issues – since we have it in the regulation that everything will go public on a certain timeframe – I think that will raise topics that will be interesting and bring up new discussions.”

Stahl ended on what the benefits of attending events, like DIA’s Clinical Trial Regulation workshop, are:

“You can learn from how the others presenting are tackling the issues and going to implement the guidelines – it’s a great way to get new ideas. I think everyone involved can gain something of value from the workshop because, really, it’s an exchange between all stakeholders; you can ask questions directly and get an immediate answer. The workshop is really an all-over view on the clinical trials environment.”
phone +41 61 225 51 36
email Kuechengasse 16 Postfach 4002 Basel, Switzerland
Print this page
Send to a friend
News and Press Releases

YHEC announces the promotions of Michelle Jenks and Rachael McCool to the role Project Director

YHEC is pleased to announce the promotions of Michelle Jenks from the Economic Modelling team and Rachael McCool from the Systematic Reviewing team to the role Project Director. Michelle has a Master’s degree (MSc) in health economics from the University of York and has conducted economic evaluations and systematic reviews for both public and private sector clients. Michelle is the lead modeller in YHEC’s role as an External Assessment Centre for NICE and has also led on a range of economic evaluations conducted for clients within industry, such as cost-utility models and budget impact models. She often leads the development of early economic analyses to inform clinical trial design and pricing strategy.
More info >>

White Papers

eSource: Reducing Site Workload for Better, Faster, Safer Clinical Trials

Clinical Ink

Unlike traditional electronic data capture (EDC), SureSource, Clinical Ink’s eSource platform, was designed from the beginning to minimize clinical trial complexity for site users. A Site Impact Survey provides scientific evidence regarding the impact of SureSource from 517 site users. Results confirm it significantly reduces workload, lessens queries, and improves data quality compared to paper and EDC. In this white paper, we quantitatively evaluate survey outcomes, provide qualitative feedback from survey respondents, and highlight the observed benefits of SureSource for transforming clinical research.
More info >>

Industry Events

5th Biennial Biosimilars & Biobetters Congress 2018

16-17 April 2018, Novotel London West Hotel, Hammersmith, London

Oxford Global are proud to present our highly anticipated 5thBiennial Biosimilars & Biobetters Congress, 16th – 17thApril 2018, London, UK. Over 450 proteins, peptides and biosimilars delegates representing leading biotech companies, global pharmaceutical organisations and internationally renowned academic institutions will enjoy over 20 presentations and case studies focusing on the key areas of the biosimilars industry including market access strategies, clinical development, commercialisation, manufacturing and bio-analytics
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement