What's New

Brookwood are pleased to be the principle sponsor for the 16th Pharmacovigilance 2018 conference in Massachusetts, USA 2nd – 4th October 2018

The Global Pharmacovigilance Market expected to Reach US$6.1 bn by 2020 expanding at a CAGR of 14.2% from 2015 to 2020 and also expected to reach a market size of $8.23 billion by 2022. By 2020, the size of the global pharmaceutical market is anticipated to grow to USD 1.3 trillion, with the E7 countries -- Brazil, China, India, Indonesia, Mexico, Russia and Turkey.

16th Pharmacovigilance 2018 will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry. The entire program will cover the detection, analysis and prevention of adverse drug reactions. It will be studied with the help of case studies and industry experiences.

This conference will help the drug safety representatives from the pharmaceutical industry and academic and quality research organizations who wish to understand how to avoid common deficiencies in inspections by learning from the experiences of others; to gain a greater understanding of new and existing Pv requirements, and to improve their organizations’ compliance with Pv requirements. Also it can help you control your product’s lifecycle, your patient’s trust, and your revenue. Hence, this conference will provide an important platform for pharmacovigilance stakeholders to discuss and share best practices in expediting Pv development. What does the future hold for Pv? Find out at our conference on opportunities and activities shaping Pv to 2020 with respect to regulations, technologies and services. Learn and know on what are drug producers and service providers doing? What regulations and technologies influence the current PV field? You can also discover at 16th Pharmacovigilance 2018 on spending forecasts for PV (US, the EU and Asia).

It gives me great pleasure in welcoming all of you to the Virtue Insight’s 16th Pharmacovigilance 2018. I wish and pray that all our efforts will be beneficial to our industries and to our country at large.

Key themes discussed at this conference

• Pharmacovigilance in the US: What comes next for the industry?
• Recent developments - legislation, policies, systems, technology, communication strategies and best practice in PV
• Optimising the overall PV ecosystem - Challenges and Opportunities
• Why does pharmacovigilance sometimes fail and where could the fault lie?
• Pharmacovigilance and healthcare system
• Technology Impact - Cloud – Big data – Analytics – AI – Machine learning
• Updates to PSUR, PBRERs, DSUR, PASS
• Good Clinical Practices and Good Pharmacovigilance practices
• Future of outsourced phase I, II and III trials and post-marketing studies,
• Data quality management and analysis – analyzing the new guidelines
• Strategies to improve clinical trials and PV
• Maintaining proper balance in relationships: Sponsor – Site – CRO & Patients
• Patient centric approach to help improve patient safety
• Outsourcing activities - Choosing your right vendor and setting the path right
• PV Audit & inspections - preparation, implementation and lessons to be learnt
• Discover approaches for collecting, integrating and analyzing all of the safety
data generated from preclinical models
• Current regulations and guidelines - USA, EU and RoW
• The developing regulatory framework in advanced and developing markets
• Be part of a major networking opportunity

For more conference details visit www.brookwoodacademy.org/documents/16th-Pharmacovigilance-2018.pdf

Good clinical practice inspection metrics
MHRA good clinical practice (GCP) metrics reports of compliance issues.
For more details: https://www.gov.uk/government/statistics/good-clinical-practice-inspection-metrics-2007-to-present?utm_source=83182773-895e-4245-a2f1-1caa36564f57&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
 

General Data Protection Regulation (GDPR)
The new EU General Data Protection Regulation (GDPR) is expected to apply in the UK from 25 May 2018. The detail of its application in the UK will be set out in a new Data Protection Act, which Parliament has yet to agree. Applicants should therefore not submit GDPR-related amendments at this time.
For health and social care research, the new Regulation is not very different from the current Act and the Health Research Authority will not be adding to the existing effective safeguards. In particular, Research Ethics Committee (REC) approval and the legal gateway for processing confidential patient information on the advice of the Confidentiality Advisory Group (CAG)  will continue, as will the other common law provisions. A summary of the key changes for all data processing (not just research) is available from the Information Governance Alliance.
The Information Commissioner’s Office has published resources for GDPR preparation, but they are not specific to research. Preparation guidance for research community is available from the Medical Research Council.
The HRA has published detailed guidance about operational arrangements that researchers and organisations may need to put in place.
We've also developed technical guidance intended for Data Protection Officers (DPO), research managers or information governance leads / security architecture leads, or equivalent. It may also be relevant for researchers. Some prior knowledge of terminology is assumed.
All guidance will be kept up to date in light of relevant national and European guidelines and the Data Protection Act 2018. As guidance becomes available, we will publicise it and link to it from this page.
Canary have two books available covering this subject which can be found at https://www.canarybooks.com/Data-Protection
An online training module is also available which can be found at https://www.brookwoodtraining-online.net/Data-Protection
 

 

Technical expert seminar on pharmaceuticals related matters, following UK withdrawal
Brussels, 8 march 2018
https://ec.europa.eu/health/documents/pharmaceutical-committee/ev_20180308_en

 

Clinical Trials and Human Subject Protection
Adherence to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) is universally recognized as a critical requirement to the conduct of research involving human subjects.  Many countries have adopted GCP principles as laws and/or regulations.  The Food and Drug Administration’s (FDA’s) regulations for the conduct of clinical trials, which have been in effect since the 1970s, address both GCP and HSP.  These FDA regulations and guidance documents are accessible from this site.  International GCP guidance documents on which FDA has collaborated and that have been adopted as official FDA guidance are also be found here.  Finally, this site includes links to other sites relevant to the conduct of clinical trials, both nationally and internationally.
To read more visit https://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm
 

 

Work plan for GCP Inspectors Working Group for 2018

22 March 2018 EMA/87812 /2018 Committees and Inspections
http://www.ema.europa.eu/docs/en_GB/document_library/Work_programme/2018/03/WC500246333.pdf

 

EMA shares progress on Brexit preparations

At the EMA Management Board meeting in December 2017, the agency shared details of preparations for its move to The Netherlands and the operational arrangements for the UK’s withdrawal from the EU. This was the first meeting of the Board since the General Affairs Council of 20 November and the decision on the EMA’s relocation to Amsterdam. The agency now has just over a year to prepare, with a deadline of 30 March 2019 for taking up its new residence.
The agency reported that collaboration with The Netherlands commenced promptly and that agreement has been reached on the joint governance structure, with plans to progress activities within five workstreams:
• temporary premises
• permanent premises
• staff relocation
• financial and legal aspects
• external communication.
A delegation from the Dutch government attended the Management Board meeting and explained
how the Dutch authorities plan to meet the EMA’s requirements. While the Dutch authorities are committed to ensuring a seamless transition of the agency’s operations to its new location in Amsterdam, it is notable that the agency’s permanent new headquarters – the tailormade Vivaldi building – is not due for completion until November 2019.
The Dutch government will offer temporary premises to the EMA from 1 January 2019 (or earlier if requested) until the new building is ready.
The EMA and the Dutch authorities are working on a Memorandum of Understanding, and a
permanent Netherlands helpdesk has been set up within the EMA to offer guidance to staff on practical aspects to facilitate their relocation.
The Board was also informed that the EMA’s Brexit preparedness business continuity plan will enter Phase 2 in January 2018, in order to free up further resources that are needed to prepare for the UK’s withdrawal from the EU. Further details will be published within the EMA’s 2018 work programme.
 The EU27 (ie. all current Member States except the UK) and the EMA have developed a methodology
for the redistribution of work currently performed by the UK’s regulatory agency. The joint redistribution
plan reflects the strengthened capacity of the European medicines regulatory network, and the risk-based methodology takes into account the diverse expertise in the network and the workload associated with the medicines. More details will be communicated soon.

Guidance for companies
The EMA website now has dedicated pages on the agency’s relocation and the agency has published
a 9-page procedural guidance document to help pharmaceutical companies prepare for the UK’s withdrawal from the EU. The document outlines the practical and simplified requirements that
companies should follow when they apply for changes to marketing authorisations to allow for the continued marketing of their medicinesin the European Economic Area post-Brexit.

The guidance assumes that the UK will become a third country on 30 March 2019. It should be read in conjunction with the questions and answers published in May 2017 on the UK’s withdrawal from the EU within the framework of the centralised procedure. Key questions relating to medicinal products include the following:
• how can I submit an application for the transfer of a marketing authorisation for my products and
what would the applicable fees be?
• how will planned or ongoing regulatory procedures be handled during the transfer of a marketing
authorisation?
• is it possible to submit a transfer of the orphan designation in parallel with a transfer of the
marketing authorisation?
• is it possible to simplify transfer applications when these are Brexit-related?
• how can I submit a transfer or change in the name/ address of an orphan drug designation sponsor?
• how do I submit changes to the Qualified Person for Pharmacovigilance and/or changes in the
Pharmacovigilance Master File location?
• how do I submit changes to the person responsible for scientific services and to the person responsible
for batch recall and quality defects?

Marketing authorisation holders, applicants and sponsors of centrally authorised medicines should consider how Brexit will impact their medicines and which changes need to be addressed before the UK leaves the EU. They also need to ensure that the necessary changes are made by that date.
The EMA is preparing a series of additional Brexit-related guidances that will be published on its website. Companies are advised to regularly check the website for new information.

 

Amsterdam wins bid to host EU medicines agency post-Brexit
http://www.bbc.co.uk/news/business-42050742

Amsterdam has won a vote to host the European Medicines Agency (EMA) which will relocate from London after the UK leaves the European Union.
The UK is losing both the EMA and the European Banking Authority (EBA) which employ around 1,000 people.
Ministers from the 27 EU countries remaining in the bloc after the UK departs in 2019 have taken part in the secret ballot.
They will now vote later on the new home for the EBA.
Some 16 cities bid for the EMA, while eight want to host the EBA - Brussels, Dublin, Frankfurt, Paris, Prague, Luxembourg City, Vienna and Warsaw.
The EMA is the more alluring of the two bodies, as it promises to make its new host into a hub for Europe's medical industry.

 

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:
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Step_4.pdf
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:
www.brookwoodacademy.org/Courses/ICH-GCP-update-for-sponsors-and-investigators

 

 

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.”

Source: <http://bit.ly/1SCN93b>

[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 info@brookwoodacademy.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
 March 2015.

 

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.

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