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Sally Francis, Panacea’s QPPV, and Anne Dougherty, Quality Manager, attended PIPA’s 7th Annual Conference and Exhibition, held in July.  The conference covered a lot of ground, with discussion and debate around key topics such as signal detection, risk management plans, copyright licensing, data protection, and the provision of medical information.

The two-day conference programme included a range of presentations and workshops from expert speakers, with around 130 delegates attending the event from a wide range of backgrounds.  These included medical information and pharmacovigilance specialists as well as vendors and recruitment agency consultants, some of whom were also exhibiting.

The first morning was a general session for all attendees.  Conference was opened by a guest motivational speaker – Marc Woods – who inspired everyone by sharing his story of becoming a Paralympic 12-time medallist including gold after a leg amputation when he was a teenager due to bone cancer.  He is an incredible man and his journey to the Gold Medal made everyone feel overwhelmed with emotion.

Dr Peter Brambleby gave an update on the NHS reform, and Kinga Papp covered the “hot topic” of social media; Mick Foy from the MHRA gave a very informative update on the new pharmacovigilance package, and Sally was honoured to be invited by PIPA to be chairperson for the second day’s morning pharmacovigilance session.  This helped to raise the profile of PPP in the industry.

In addition to all the learning, Sally and Anne enjoyed the networking opportunities provided by both discussion in the workshop sessions, and through the more informal evening social event, at which everyone wore 1920s fancy dress costumes.

Panacea was delighted to have had two members of the company attend the PIPA Conference, and we look forward to returning next year.

November 9, 2012 at 6:10 pm
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Lena Demetre has been appointed as Business Development Manager, joining PPP to help deliver a demanding strategic growth plan.

Lena has worked in the pharmaceutical industry for the past 11 years, and has been involved with clinical trials as a CT Project Manager with the AmerisourceBergen Group, and is also well-known in industry circles through her out-licensing role with the highly-reputed generic developer, Pharmathen. Lena brings her industry knowledge and substantial experience to PPP and we are proud to add yet another talented professional to our growing team. As well as being responsible for business development and marketing activities Lena is the primary contact for all customer enquiries, proposals and commercial agreements.

Asked about her new role in PPP, Lena said: “I am extremely pleased to join the team at PPP. My focus is to achieve the highest level of customer service with a keen eye on quality deliverance; a sentiment I immediately realised is enthusiastically shared by the whole pharmacovigilance team here at PPP.”

Director, Craig Wolstencroft, said: “To succeed in our strategies of sustainability, growth and delivering high-quality services to the industry it is essential that we continue to recruit exceptional staff, even if we have to be patient to do so. Finding people of Lena’s high calibre is never easy, but we will not compromise on getting the right person. Lena will be another valuable asset in our team and I am thrilled to welcome her to PPP.”

September 16, 2012 at 1:56 pm
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In March 2010, the French regulatory authority responsible for medical devices issued a warning regarding the quality of breast implants, manufactured by the French firm Poly Implant Prothèse (PIP), with the UK regulatory authority issuing a medical device alert at the same time.

The alert warned that breast implants manufactured by PIP from 2001 to 2010 had been manufactured with unapproved silicone, but the impact of the use of the unapproved silicone on the quality of the implants has been much debated. In December 2011, the French authorities issued an update recommending French women to have the affected implants removed. Since then, there has been widespread media coverage of the potential risks, but the European Commission has not drawn any conclusions on the potential health impact and as recently as this month (February 2012) has requested further in-depth study on the potential health impact of faulty breast implants.

Whatever the outcome, the issue of medical device safety and the certification process is now firmly in the spotlight. Under European law, medical devices are required to have a CE certification issued by a Notified Body. To acquire this certification, certain standards have to be met that ensure the quality of the products in all aspects of design, manufacture and product safety monitoring. It is these requirements that are coming under increasing scrutiny and the scandal of the PIP implants has intensified the debate.

Health and Consumers Commissioner from the European Commission, John Dalli said: “The Commission will discuss with the Member States a series of immediate measures to strengthen the existing surveillance and safety controls on medical devices already on the market. The capacity to detect and minimize the risk of fraud must be increased. We had already been working on a revision of the Medical Devices Directive, envisaged for adoption this spring (2012). We will now also take into account the lessons learnt from this case and take them on board in redrafting our legislation, in particular with regard to market surveillance, vigilance and functioning of notified bodies.”

It is clear that changes to Medical Device Legislation are imminent for the Medical Device industry with regards to CE certification and postmarketing surveillance. PPP is constantly monitoring this situation and will keep up to date with all changes to Medical Device Legislation.

September 5, 2012 at 11:03 am
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The risk management plan (RMP) is a document designed to provide a description of the risk-minimisation strategy in place for a pharmaceutical product. The aim is to ensure that the benefits of a product exceed the risks by the greatest achievable margin. The document itself is divided into several parts and guidance to the information required is given in the new Guidelines for Good Pharmacovigilance Practices (GVP) Module V.

The new format is divided in to seven parts; product overview, safety specification, pharmacovigilance plan, plans for long-term and real world efficacy follow up, the risk-minimisation plan, summary of activities in the EU-RMP by product and finally the annexes. In time, the summaries of RMPs will be made publicly available via EU web portals. A detailed template for all RMPs is currently being finalised and awaits final approval by the Pharmacovigilance Risk Assessment Committee (PRAC) in due course. Until then, companies are able to continue to use the old template or work with the new legislation to follow the new format.

For many working in generic pharmaceutical companies RMPs have, until now, been a theory rather than a reality as they were rarely required for well-established pharmaceutical products. However, from July 2012, a Risk Management Plan (RMP) will be required for all new Marketing Authorisation applications in the EU.

With a team of individuals with experience from both generic and innovator pharmaceutical companies we feel that we are well placed to tackle the new RMP and the questions which will no doubt arise from both industry and the authorities as it moves forward. We look forward to working with our clients in facing the challenges ahead.

September 2, 2012 at 12:45 pm
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Whether we like it or not, our lives are being swamped by modern technology. Gone are the days of typewriters, dictionaries, and paper notepads. It is hard to imagine how we ever survived without mobile phones, computers, and SatNavs! The Internet is now so advanced and readily available that it can give us the answer to anything we want to know, and it can do so in an instant.

When the Internet started out it was just about websites, but then along came . . . Social Media. The content of social media sites is created and controlled by the users themselves; i.e. all of us. Examples of the sites I am referring to include Facebook, Twitter, Flickr, LinkedIn and YouTube. Social Media networking is the integration of technology and social interaction – it enables us to publish, share, discuss, blog, network and build relationships. It is abundantly clear that social media is not a fad or phase, but is here to stay. You may be wondering how social media is relevant to our jobs. Indeed, many companies block their employees from accessing social media fearing they will be using work time inappropriately. However, it’s not all bad. I am a member of LinkedIn which is undoubtedly useful for networking but also I have found the groups helpful, such as PIPA, for postings, polls, discussions and Q&As.

More recently, I decided to join Twitter, not because I wish to follow Britney Spears, and not because I feel I have anything I wish to tweet to the world, but as a trial to see if it does offer any value to my working day. I have managed to find and follow the MHRA, ABPI, DIA, the FDA and of course Panacea Pharma Projects (@ PanaceaPP).

So far, the best revelation is that I can follow the European Medicines Agency and be notified immediately of any new press releases, the most crucial being when the new pharmacovigilance modules were published. The EMA has no email alerting system so this now saves me having to remember to search their website each day. Another positive is being able to read people’s tweets who are attending conferences and training days, and sometimes speakers will tweet links to their slides. Even politicians are including social media in government plans and this week The Health Secretary, Andrew Lansley, has shown his support for technology saying, “Innovation and technology can revolutionise the health service, and we are looking at how the NHS can use these apps for the benefit of patients, including how GPs could offer them for free.” This quote is taken from the Department of Health’s press release entitled ‘GPs to prescribe apps for patients’. The article summarised an event showcasing the best ideas for new and existing health Smartphone apps. This event followed a call to find the best new ideas and existing Smartphone apps that help patients and doctors better manage care.

The most popular app ideas were to: help manage long-term conditions such as diabetes, to help people deal with post-traumatic stress, track and monitor conditions such as high blood pressure, help people find NHS services on a map, get practical information about keeping fit and eating healthily. Aside from all the fun that can be had via social media there is a serious implication for Marketing Authorisation Holders. Health is the most talked about topic on-line worldwide and for those of us in the pharmaceutical industry that has a huge impact.

There is now total freedom for the public to be able to share any experiences they have had with a drug be it an adverse event or a product complaint. We are all well aware by now that company email addresses and fax machines must be monitored for potential in-coming reports of adverse events and product complaints. But, what must we do about monitoring postings on company websites?

The limited guidance available is complex and conflicting with differing approaches globally. The Regulatory Authorities will expect Marketing Authorisation Holders to demonstrate how they perform searches of company owned (www.company.com), controlled (facebook. com/companypage), sponsored (charity.com/diseaseinfo) and independent (the rest of the internet) websites. Where is the legal basis for these requirements?

Here is a summary:

Volume 9a

“MAHs should regularly screen websites under their management or responsibility, for potential reports on adverse reactions. The MAH is not expected to screen external websites for information on adverse reactions. However, if a MAH becomes aware of an adverse reaction on any other website the MAH should review the case and determine whether it should be reported in expedited manner.”

The Purple Guide

“The wealth of information available on the Internet and its widespread accessibility means it is an increasingly popular way to seek and share information. “ Contact Us” pages now frequently display generic company email addresses or website enquiry forms. The MAH must consider the mechanism by which incoming information is monitored to allow the identification and transfer of pharmacovigilance data to the correct person in an appropriate timeframe to meet regulatory reporting requirements”.

“A procedure should be in place to ensure daily screening by a designated person(s) of the website(s) in order to identify potential safety case reports. The working group does not believe it necessary for regulators or companies routinely to “surf” the internet beyond their own sites for individual spontaneous reports”.

ABPI Pharmacovigilance Expert Network

The ABPI PEN issued guidance notes on the management of adverse events and product complaints from pharmaceutical company sponsored websites in June 2011. For more information go to: www.abpi.org.uk/our-work/library/industry/Pages/pharmacovigilance-the-internet.aspx. At the same time, a White Paper was released calling for changes to the current pharmacovigilance legislative framework. For more information go to: www.abpi.org.uk/our-work/news/2011/Pages/130611.aspx

FDA

The FDA released draft guidance in December 2011“Responding to requests for off-label information”. For more information go to: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM285145.pdf

Prescription Medicines Code of Practice Authority

The PMCPA has issued informal guidance on digital communications. The new guidance highlights relevant Code requirements and
includes questions and answers. For more information go to: http://pmcpa.org.uk/?q=node/920

So what’s next? Well, we will wait to see if the ABPI PEN’s White Paper has any influence and perhaps there will be more robust guidance perhaps there will be more robust guidance
coming out in July.

May 15, 2012 at 2:55 pm
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Audits are like Marmite – you either love them or hate them. Or rather, you either loathe them, or you find them sometimes uncomfortable, but can see the positives; can understand why audits should be done and done thoroughly.

Unfortunately for the audit-loathers, auditing is a key part of any pharmacovigilance system. From massive global pharma with their complex quality systems and dedicated Quality Assurance teams all the way down to the tiniest Market Authorisation Holder (MAH) who holds one licence in one country and outsources all their technical services – auditing is essential.

Auditing is the key way in which a company checks that its procedures are being followed, or even understood, or that another company it relies on for contracted services are doing what they say they are and the quality of service is up to scratch. Without audits, the company is blind to its own shortcomings or those of its partners and so is unable to manage its own quality. At PPP, we have a good deal of experience of various types of audits and inspections drawn from staff members’ previous areas of work and also from PPP’s current client work. Any client that PPP conduct pharmacovigilance services for will be encouraged to come and audit the company. This isn’t said to show off about how confident we are in our systems; instead it is to ensure that the client is aware of the systems they are reliant upon and to ensure that both we and our partners are striving for excellence (and we’re pretty confident in our systems too!).

PPP will also always carry out audits of our clients based on the pharmacovigilance duties they cannot outsource to us, such as providing us with any reports they received direct to the MAH, or performing recalls. We are aware that this seems daunting to clients with limited technical expertise in-house, but it is essential to ensure that the client is proofed against any regulatory inspections later. When carrying out these audits, PPP both examines the systems in place and then is happy to help and advise in areas which need improvement.

Whatever you think of audits, they are part of life. PPP is committed to providing the best service for their clients and therefore organises internal and external audits of ourselves, encourages clients to audit us and audits clients. We are also available to perform ad hoc audits for companies for which we do not carry out any other pharmacovigilance services. Although uncomfortable at the time, audits should always be seen by the auditor and the auditee as an opportunity for review, approval of what is good, and improvement of those areas which are not so great, and that’s what we aim to provide every time.

April 9, 2012 at 2:29 pm
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With the new pharmacovigilance legislation coming into force on July 2nd 2012, at PPP we have been relieved to see the publication of the public consultation documents on the first seven modules of the Good Pharmacovigilance Practice (GVP) guidelines. These seven modules form the first wave of the implementation guidance on the new legislation and, although still not finalised, will give us a much better picture of what is expected come July.

The seven modules of GVP released so far include details of Quality Systems, Pharmacovigilance System Master File, Risk Management, ADR reporting, PSURs, Post-Authorisation Safety Studies and Signal Management. Each module is split into three sections – Introduction, giving the legal basis and an overview of the module; Structures and Processes, which it is hoped could allow harmonisation outside of Europe; and Operation of the EU network, giving details of the requirements for role and responsibilities of European stakeholders. One of the big changes from this first raft of modules is the implementation of the new Pharmacovigilance System Master File (PSMF), the details of which is the subject of Module II of the GVP guidelines.

This module defines the requirements for the PSMF, including its maintenance, content, and associated submissions to competent authorities. Although it would not be possible to go through all the details of this guidance in a short article, it is clear from Module II that MAHs retain the overall responsibility for pharmacovigilance. They will be required to ensure that the PSMF is created, maintained and is accessible to the QPPV and to competent authorities. As the PSMF will form the basis of inspections, it is essential that it is kept up to date and is well version controlled to ensure that the information is accurate. Some of the main challenges which will face the industry on the basis of this draft PSMF guidance are listed below.

The maintenance of the PSMF both as a living document, which may change very regularly, and also as a controlled document forming a core part of the MAH’s quality system. The efficient completion of any Corrective and Preventive Actions from audits or inspections as findings and actions must form part of the PSMF until they are demonstrably resolved. For some companies, even just the issues of location of the PSMF within the EU may become a thorny issue as non-EU MAHs or companies, which carry out their PhV outside of the EU, will have to decide where to declare their PSMF to be located.

Detailed information on procedures, which may be changing frequently during the rollout of the various GVP modules must be included and kept up to date, complete with compliance figures, organisational charts and MAs for which the PSMF is used. The stated objective of the new pharmacovigilance legislation is the protection of patients’ and public health, which every company involved in the pharmaceutical industry must applaud. The increased cost and workload of maintaining the PSMF, when set against a reduction in patient hospitalisations or fatalities due to drug reactions is something we would gladly embrace.

However, in the current economic climate, it is also essential to ensure that these new requirements form an efficient part of the overall business to enable the pharma industry to continue development of better and more cost-effective products. It is a priority at Panacea Pharma Projects Limited that we seek to understand and address these issues within the context of our current and future clients to ensure that we provide the best possible support and advice over this transitional period where the new legislation is coming into effect and processes are changing throughout the industry.

April 2, 2012 at 5:52 pm
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The new EU Pharmacovigilance Legislation will come into effect in July 2012, although the updated Directive (2011/83/EC) and Regulation (No 726/2004) have been available for some time, any real guidance on implementing these is yet to be released. On 8th September the European Commission published a Concept Paper for the implementing measures.

At PPP, eager to find out as much as we can and as soon as possible, we made contact with Mick Foy, Group Manager – Vigilance Intelligence and Research Group, at the Medicines and Healthcare products Regulatory Agency (MHRA) and sought further clarification relating specifically to the changes to the Detailed Description of Pharmacovigilance Systems (DDPS).

Current Practice

All Marketing Authorisation Holders are required to submit a DDPS with each Marketing Authorisation Application. The DDPS must include the name, address and contact details of a Qualified Person for pharmacovigilance (QPPV) and a Deputy QPPV. Therefore, if a company wishes to change the named person, address and / or contact details for the QPPV or Deputy QPPV then the DDPS must be updated and a Type 1A Variation must be submitted for each Marketing Authorisation for each change. This can become extremely costly to MAHs as most EU Authorities charge a fee for a Type 1A Variation, although this is not the case for the MHRA.

The Future

The majority of EU Authorities are in agreement that this system needs to change and are working with the European Commission on a draft proposal. The new legislation states that a Pharmacovigilance System Master File (PSMF) will replace the DDPS. Mick Foy has kindly provided us with some more details. A PSMF will negate the need for submitting variations to each EU Authority every time an update is made. In fact, the PSMF will not need to be submitted to EU Authorities at all but instead a standard paragraph will be included in all Marketing Authorisation Applications stating where the PSMF is held.

The proposal is that QPPV contact details will be cross-referenced to other sources, meaning that there will not be a requirement to submit variations should these change. Type 1A variations will only be required if the nominated QPPV changes or the country of location of the PSMF changes. The reason that the requirement to submit variations for changes in QPPV will remain, is because it is considered necessary that there is a legal basis to ensure that EU Authorities have access to current QPPV information. This new approach could potentially significantly reduce the cost burden to MAHs. Our understanding at this time is that there will be no variation for a change to the nominated Deputy QPPV.

The Snag

While all of the above sounds encouraging and hopeful, the existing variations legislation (Commission Regulation (EC) No 1234/2008) does not take into account the new pharmacovigilance legislation changes. The variations legislation is not under review at present and this means that there remain many obstacles to implementing the above. To confuse matters further, in August PPP directly contacted each EU Authority to enquire whether multiple variation fees (where applicable) will be waivered with the implementation of a PSMF, and responses were mixed. The Austrian Authority categorically said no; whereas the German Authority said “probably not” and the Polish and Latvian Authorities said they did not know yet. The Spanish Authority’s response was in-line with the MHRA.

Clearly, there are a lot of issues still to be resolved and there is a long way to go until July 2012. PPP staff members will be attending a number of training courses being held towards the end of this year where there will be speakers from the Authorities. We will feed back any relevant information gathered at these courses. However, as nothing is definite at this time we continue to await further guidance and we look forward to bringing our clients and others up to speed once we know more.

October 28, 2011 at 9:39 am
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Daniel McKay, Head of Pharmacovigilance at PPP, attended a one-day course run by British Standards Institute on PMS and vigilance as they relate to Medical Devices. Dan gives us his impression of the course.

The medical device industry has undergone many changes with respect to vigilance and Post Market Surveillance (PMS) over the last 5 to 10 years. The emphasis on risk management and reporting compliance is ever more the focus of audits and inspections and manufacturer’s are, quite rightly, having to focus more and more on the regulations and requirements to ensure a compliant PMS and vigilance system. In order to maintain an awareness and keep up to date with a familiar subject, British Standards Institute (BSi) are an independent, private, non-profit distributing company which helps organizations improve their quality and performance, reduce their risk, manage and protect their reputations, and help them be more sustainable. They are a Notified Body and help manufacturers gain CE certification and ensure that manufacturers meet the relevant conformity assessments and essential requirements as well as a compliant quality management system.

The relevant directives for device manufacturers are as follows: Medical Device Directive (93/42/EEC), Active Implantable devices (90/385/EEC) In Vitro Diagnostic devices (98/79/EC). These directives as well as the relevant harmonised standards and MEDDEV guidelines were the fundamental part of the training in terms of the reference point for manufacturers for implementing a compliant vigilance system and meeting PMS requirements. Risk management was the underlying theme of all the discussions on PMS and post-market clinical follow-up (PMCF) as well as the reactive and proactive elements of PMS. The key standards with relevance for PMS and vigilance, that manufacturers are required to follow and were discussed during the training, are ISO 13485:2003 and ISO 14971:2009.

The vigilance aspect of the training focussed strongly on the requirements of MEDDEV 2.12-1 and the definitions and varying situations that manufacturers face on a regular basis for determining reportability of single adverse incidents. Dan’s view of the course and its content was a positive one, “Overall, the course as a good overview of manufacturer’s vigilance and PMS responsibilities. To cover all aspects in one day is very difficult, but I considered the balance to be very good in terms of lecture / presentation time and practical exercises with examples. Given that it was a one-day course, it gave the delegates a good understanding of what is required and the reference material. For delegates with a good understanding of the requirements, this was a good refresher course, with some additional focus on PMCF and manufacturer’s requirements in clinical investigations and evaluations. For those new to PMS and vigilance, it was a good introduction to the requirements and where to find the information.

One additional area I believe that this course needs to cover is field safety corrective actions (FSCA) which is a fundamental part of MEDDEV 2.12-1 and therefore part of a manufacturer’s responsibility to have a compliant vigilance system. The tutor confirmed to me that no other course addresses FSCA handling and so I believe this would be a good addition to this course. One piece of news that was announced was that an update to ISO 13485 has begun, but is expected take a couple of years to be published.

The outcome of this course is that compliance with vigilance and PMS requirements requires knowledge of the directives, standards, and guidelines, therefore manufacturers need to keep their systems and procedures current with the latest guidance and standards to ensure there are no nasty surprises at audit and to ensure their products are brought market as quickly as possible.

September 25, 2011 at 5:27 pm
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CPhI Worldwide, the world’s leading pharmaceutical networking event, was held in Messe Frankfurt, Germany, from 25 – 27 October 2011.

QPPV, Sally Francis, who attended the event representing PPP, said, “CPhI is an important event for everyone in the industry and attracts 28,500 visitors with 1,800 exhibitors from more than 140 countries. It’s a chance to meet face-to-face with international pharma companies and to learn about the latest industry trends. From PPP’s point of view it is a vital attend for the benefit of our company and our clients. Every year, more than 95% of visitors make new business contacts and CPhI is also a popular event for launching new products.”

September 3, 2011 at 3:22 pm
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