Update in Clinical research & GCP – Copenhagen 23rd October 2017
Refreshments & Registration from 8.30am
• EU Clinical Trial Regulation 2014 No. 536
A brief overview of the finalised Regulation awaiting implementation
• Risk proportionate approaches in clinical trials
Summary of the latest EMA Recommendations
• Pharmacovigilance update
Inspectors want to see that all staff have some basic PV knowledge. This session will
provide an update on what’s new as well as to provide some PV basics.
• Inspection expectations for the Trial Master File
Highlights of the EMA’s Trial Master File draft Reflection Paper
• Q&A using keypads on the draft EMA Serious breaches guideline
• EMA First-in-Human Guidance
A summary of EMA’s 2017 guideline on first-in-human studies
• Latest news on what’s coming and new
Including: AxMPs, modernization of ICH E8 and its knock on impact on ICH GCP E6,
Delegated Regulation on GMP affecting
Check out the website at www.brookwoodacademy.org to book a place
EU Clinical Trials Regulation: an update
Despite early promise that the EU Clinical Trials Regulation (No. 536/2014) might have been implemented in May 2016, it is now clear that it will not come into operation until 2018.
The Regulation aims to create an environment that is favourable for conducting clinical trials in the EU, with the highest standards of safety for participants and increased transparency of trial information.
The Regulation will harmonise the assessment and supervision processes for clinical trials via an EU
portal and database, set up and maintained by the European Medicines Agency (EMA) in collaboration with Member States and the European Commission.
Consequently, the rate-limiting step for implementing the Regulation has always been confirmation of the full functionality of the portal and database through an independent audit.
The EMA’s current delivery timeframe indicates that the EU portal and database should be available for independent audit by August 2017. If the systems pass the audit, the Regulation will come into effect by October 2018.
Lengthy transitional period
Assuming that the Regulation does come into effect in October 2018 – and the EMA states that it is doing everything possible to bring this date forward – there will be a 3-year transition period until October 2021, during which there will be an overlap of the new Clinical Trials Regulation with the Clinical Trials Directive 2001/20/EC:
• from October 2018 to October 2019, applications for clinical trials may be submitted under either the new Regulation using the EU portal and database or under the current Directive using the EudraCT database
• from October 2019 to October 2021, only clinical trials authorised under the Directive will continue to be governed by that Directive
• from October 2021, any ongoing trials that were originally authorised under the Directive will
fall under the new Regulation and will be governed accordingly.
ICH GCP E6 (R2) is born
The new ICH GCP guidelines including the Integrated Addendum E6 (R2) have finally been published and are now available to view in the ICH website at:
Here at Canary we have been busy rewriting our own version of the guidelines with a copyrighted index which allows users to search for the appropriate sections using subject index and key words.
It is ideal for investigators, monitors, auditors, regulatory authority inspectors, members of ethics committees and others who need regular access to the GCP guidelines. Prices start from as low as £3 per copy. For more details see our website at www.canarybooks.com. Our publication is available as a handy pocketbook or larger format A5 desk version.
Need a short course to update your staff on the new ICH GCP Guidelines Addendum E6 R2 ?
November 2016 marks a milestone in GCP history when the proposed changes to the ICH GCP guidelines in addendum R2 are signed off as a Step 4 document.
This webinar will cover the changes the addendum brings and its impact for sponsors and investigators.
The short course will include:
Online .......... On Demand .......... Global ..........
Take the course at a time to suit you.
ONLY £30 per participant
To Book online visit:
Hot news from 2nd European QA Conference in Nice
FDA has acceptance of e Consent and published guidance. Concept not so acceptable in EU. See next issue of Advisor
eTMF guidance from EMA IWG is due out for consultation in 5-6 weeks. Gabrielle Schwartz - Head of GCP inspection Germany
EGA becomes Medicines for Europe
The European Generic and Biosimilar Medicines Association (EGA) has become Medicines for Europe. The new body has highlighted the importance of both generic and biosimilar medicines to European healthcare. The generic and biosimilar industries currently supply the majority of Europe’s prescription medicines, and this contribution is estimated to reach 75% in volume over the next 5 years. The repositioning of the EGA as Medicines for Europe aims to drive greater healthcare efficiency through better health outcomes, while providing solutions for the sustainability of European healthcare systems facing increased demographic demands on healthcare services.
Adrian van den Hoven, Medicines for Europe Director General, stated, “Medicines for Europe is a great opportunity to build on the EGA’s established reputation for partnership with stakeholders and authorities to deliver access to high quality medicines for patients, its commitment to the highest levels of quality, and to bringing even more value to pharmaceuticals while bridging the sustainability of healthcare with a competitive pharmaceutical manufacturing industry.”
[original source www.medicinesforeurope.com/news/ega-becomes-medicines-for-europe/]
Poor publication and reporting rates for trials at US academic medical centres
Researchers in the USA have assessed the rates of publication and reporting of clinical trial results by leading academic centres. The primary outcome measure was the proportion of trials that disseminated results – defined as publication or reporting on <ClinicalTrials.gov> – both overall and within 24 months of study completion. The assessment focused only on academic medical centres that had 40 or more completed interventional trials registered on <ClinicalTrials.gov>, and on clinical trials with a primary completion date between October 2007 and September 2010. In addition, the lead investigator had to be affiliated with an academic medical centre.
The study findings were reported in <I>BMJ</I> and can be summarised as follows:
l among 4347 interventional clinical trials from across 51 academic medical centres, 1005 (23%) enrolled more than 100 patients, 1216 (28%) were double-blind and 2169 (50%) were Phases II to IV
l academic medical centres disseminated results for 2892 (66%) trials, with 1560 (36%) achieving this within 24 months of study completion
l the proportion of clinical trials with results disseminated within 24 months of study completion ranged from 16% (6/37) to 55% (57/103) across the centres
l the proportion of clinical trials published within 24 months of study completion ranged from 11% (4/37) to 40% (31/77) across the centres, whereas results reporting on <ClinicalTrials.gov> ranged from 2% (2/122) to 41% (72/177).
The authors concluded that, despite best intentions, over the period of evaluation there was poor performance and noticeable variation in the dissemination of clinical trial results across leading academic medical centres in the USA.
Source: </I>BMJ<I> 2016;352:i637, <http://bit.ly/1OhXlaf>
[original source www.bmj.com/content/352/bmj.i637]
Update Seminar in Clinical Research & GCP
As part of the pre-conference training at the European QA conference Brookwood Academy are pleased to offer:
An Update Seminar in Clinical Research & GCP
Tuesday 26th April 2016 Nice Acropolis, Nice, France
Ideal update and refresher consisting of executive summaries of the latest developments and discussion of clinical research topics to satisfy ongoing training needs.
Course Content Includes:
• Impact of the revision to the ICH GCP guidelines E6 R2
• Overview of the new EU Clinical Trial Regulation No.2014/536
• GCP update and refresher – an interactive Q&A on GCP questions and problems
• Consent in clinical trials – GCP requirements, individualising consent and testing knowledge
• Serious breaches – understanding the new reporting requirement with case studies
This seminar is suitable for those who need to update their general knowledge and to demonstrate recent and up-to-date training: those overseeing or actively managing clinical trials as sponsors, monitors, auditors, investigators, supervisors and administrators; academics; those responsible for research governance, members of ethics committees and site personnel involved in both commercial and non-commercial trials covered by European legislation
Price: €350 per person for bookings made until 31st March 2016 €450 per person thereafter. Discounts for groups can be negotiated. Book early to avoid disappointment as places are limited
Bookings can be made online at https://brookwoodacademy.org/Update-and-Refresher-Course-in-Clinical-Research-and-GCP
Bookings for the seminar may also be made by email at firstname.lastname@example.org or by calling (from UK) 01483 811383; from elsewhere +44 1483 811383
An invoice will be issued. Your place will be confirmed once payment has been received. Cancellations not permitted but the named participant may be replaced at any time.
MHRA releases latest annual pharmacovigilance inspection metrics
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has summarised the findings of
inspections performed by the Good Pharmacovigilance Practice (GPvP) Inspectorate in the 12 months to
FDA issues draft best practice guidance
New draft guidance describes best practices for communication between the FDA and sponsors of investigational new drug applications (INDs). Published in the Federal Register on 9 December 2015, the new guidance aims to facilitate the earlier availability of safe and effective drugs to the US public. It recommends procedures for timely, transparent and effective communication between IND sponsors and the FDA at critical junctures in the drug development process.
The document details
• FDA philosophy on timely interactive communication with IND sponsors
• the scope of appropriate interactions between the review team and the sponsor
• the types of advice appropriate for sponsors to seek from the FDA in pursuing their drug development programme
• general expectations for the timing of FDA responses to sponsor enquiries
• best practices and communication methods to facilitate interactions between the FDA review team and the IND sponsor
• the expectations for appropriate methods for such communication, including their frequency.
The draft guidance is available for a 60-day consultation period until 8 February 2016.
Latest Clinical Trials Regulation timeline
At a meeting on 16–17 December 2015, the European Medicines Agency’s (EMA’s) Management Board formally adopted the agency’s multi-annual programme and work plan for 2016.
Details of the EMA’s work programme for 2016 will be published in the first quarter of 2016, but a few highlights are already available. The agency has also made the following forecasts on key medicines development activities:
• the level of pre-authorisation activities for human medicines is expected to be stable, with
around 546 requests for scientific advice in 2016 compared with 510 in 2015
• approximately 33 requests for parallel advice with heath technology assessment bodies are expected
• the number of applications for initial marketing authorisation is expected to remain constant, with
110 applications in 2016 compared with 112 in 2015
• the number of applications for medicines containing a new active substance should also remain stable.
EU clinical trial portal and database
The agency’s multi-annual programme makes reference to the EU clinical trial portal and database,
the single portal for the submission and maintenance of clinical trial applications and authorisations that will underpin the new European Clinical Trials Regulation. The portal and database will also serve as the source of public information on the full lifecycle of all clinical trials conducted in the EU.
It is critically important that the EU system provides the required functionalities for all stakeholders in the most efficient and stable way possible from the outset, so as to ensure the delivery of the broad-reaching benefits foreseen by the Clinical Trials Regulation.
The following timeframe for the implementation of the portal and database was endorsed at the
Management Board meeting, and outlined in an EMA notification on 17 December 2015:
• independent audit: August – November 2017
• audit endorsed by EMA Management Board: December 2017
• European Commission notice published in the Official Journal of the European Union: March 2018
• Production Version completed: July 2018
• Production Version available: September 2018
• Clinical Trials Regulation (EU) No. 536/2014 becomes applicable: October 2018.
The new Clinical Trials Regulation entered into force on 16 June 2014. At that time it was stated
that the Regulation will apply no earlier than 28 May 2016, so for many the new October 2018 date may seem surprisingly far away. The agency is keen to stress that the current timeframe includes
provision for the resolution of unforeseen difficulties and potential issues (ie. it is considered to be a
maximum), and that all possible efforts will be made to bring the Regulation into operation earlier.