Firmly Focused on Safety – Panacea feature in ‘The Times’ Newspaper

When Stuart Colligon launched his company Panacea in Douglas on the Isle of Man back in 2008, it was a time when his chosen sector was – as he recalls – “about as popular as the poll tax” which clearly indicates the regard in which it was held as this had resulted in riots in the UK.

For pharmacovigilance, the process of collecting, monitoring, researching and evaluating the adverse effects of medications, was then viewed as a necessary evil, effectively a grudge purchase by his potential clients in the booming generic drugs marketplace.

And having previously worked in business development in the pharmaceutical industry internationally, Stuart Colligon had identified this as a niche market with considerable commercial potential. He chose the Isle of Man not only because he was living there at the time but because the government were helpful and there was an established Manx life science cluster.

Here was a market that he was aware had exploded with the proliferation of generic pharmaceutical companies and generic product licenses in the early 2000s as a result of a raft of medicinal product patents expiring after 20 years of protection (based on a 15-year patent timeline and a further five-year special protection certificate) which saw the originators have to give up their market monopoly of the drugs on which they had spent multi-million pounds to develop.

Even over-the-counter drugs such as hay fever remedies that once sold for £4 were now available at a quarter of the price. So everyone appeared to be happy – the users, the health service because it drove costs down and certainly the generic license holders. However, the same did not hold true for the companies who had spent years researching and developing the original products, only to lose market share to rival commercial operations who reverse engineered the products. That is why many of the original developers have in fact now included the generic route in their portfolios themselves.

While a few of the giants like Pfizer fought back by patenting both the colour (blue) and the shape(diamond) of their blockbuster pill Viagra, even they eventually lost dominance in what was eventually the pharmaceutical equivalent of the gold rush.

However there still remained real concern over the potential for another Thalidomide disaster which took place in 1961 when thousands of congenitally deformed infants were born as the result of being exposed in utero to the medicine when it was prescribed to pregnant women to combat morning sickness. That in turn sparked the first systematic international efforts to address drug safety issues and the ultimate emergence of the practice and science of pharmacovigilance.

When the generics boom started at the turn of the century, the problem, though, was that this concern appeared to be confined to the regulatory authorities rather than the generic drug companies themselves, who seemed convinced they could rely on the safety track records – often over two decades – of the products they were licensing. But they still had to comply when powerful bodies such as the EMA in Europe, the MHRA in the UK and the FDA in the States acted to ensure that mandatory pharmacovigilance was properly applied by the generics players.

So initially in their collective frustration they saw the answer lay in ‘buying cheap’ and consequently pharmacovigilance companies either willing to provide a ‘bare minimum’ service, or in countries with low wages reaped the financial rewards.

However, the sector did not escape without incident and with the threat of product recalls and potentially being closed down hanging over them if safety standards were not met, eventually companies experienced a change of heart amid a growing realisation that here was a situation that needed to be taken seriously – and that pharmacovigilance offered a true level of security, both for their businesses and their customers.

Stuart Colligon, founder of Panacea, says the company’s service is ‘quality first’
In recent years, this has seen an increasing number of companies willing to pay for quality. “There has been an acceptance within the industry that cheap is not necessarily best when it comes to pharmacovigilance. Quality is now seen as key – and our service is very much quality first,” insists Stuart Colligon.

Just how important pharmacovigilance is for the end user of drugs was illustrated when Panacea became the first company in the world to spot significant problems with an antiseptic solution used on the skin. It discovered the appropriate remedial action when it found cases in which the product caused burns to premature babies when used at times of catheter insertion and is why Panacea today finds itself in the top five pharmacovigilance companies operating in the UK and Europe.

Working from secure, dedicated offices in the island’s capital, Panacea is responsible for monitoring the safety of medicines with marketing authorisations in every EU country and beyond and does so from its Isle of Man HQ and United Kingdom offices. From here it is currently concentrating on expanding its customer base across the EU.

It has experience of successful inspections from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), the Irish Medicines Board (IMB), and the Food and Drug Agency (FDA).

The company has extensive disaster recovery plans in place which involve real-time off-site backup of all its operations and data. This means that in the event of an emergency all its critical pharmacovigilance processes can continue uninterrupted and its clients’ critical data is protected at all times.

Two senior members of its management team have postgraduate qualifications in pharmacovigilance, while other employees are currently studying for the same. As part of the requirement to work in the EU pharmaceutical industry, it is necessary that a company has experts living within the EU. And as the Isle of Man is not a member, they currently reside in the UK itself. Now, with Brexit looming, Panacea is already making contingency plans to recruit additional experts in other parts of the EU.

This is all part of Panacea’s ongoing strategy to ensure that they are at the leading edge of pharmacovigilance.

“We have a dedicated quality management function which ensures that all our work – at every level – is checked, audited, and compared with best practice and complies with the highest and latest standards,” says Mr Colligon.

“We invest significantly in training. Each member of staff has modular training that is tailored to their role within Panacea and is modified if their responsibilities change. Training is updated on an annual basis or earlier, as necessary. I am deeply proud of the people that we have in Panacea; they are exceptional and this, ultimately, is what enables us to deliver such a high level of service to customers.”

Panacea’s professionalism also seems to have won fans in high places.

A recent conference on pharmacovigilance saw an attack on the quality of the service available to companies from one of the delegates.

This brought a quick response from a panel representative who singled out Panacea as an example of the high quality that is now available to generic drug companies today.

View Article as PDF

Panacea Shortlisted for ‘Industry Partner of the Year’ Award

CPhI 2016 - Global Generics & Biosimilar Awards

Held at the Fira de Barcelona, Panacea attended the annual CPhI worldwide (one of the world’s largest pharmaceutical trade shows) for a sixth consecutive year. The conference is a great opportunity to discover the latest hot topics and understand industry developments. The event also provides the perfect opportunity for meeting with existing clients and to network with some of the 36,000 pharma professionals attending from over 150 different countries. gg-trophy

This year, Panacea were thrilled to have been shortlisted for the “Industry Partner of the Year” at The Global Generics and Biosimilars Awards 2016. The award aims to recognise the achievements of CROs and service providers to the generics and biosimilar industries. This year’s ceremony was held at Hotel Porta Fira, near to the main conference centre and was well attended by some of the biggest pharma companies in the world.

Panacea left the CPhI with a multitude of new industry connections and we look forward to continuing to build and maintain excellent relationships with our clients during 2017.

 

Panacea update on ISO IDMP implementation

Panacea embraces its responsibility, on behalf of clients, to keep abreast of changes in legislation and guidelines. Currently, one of the most notable changes is the impending implementation of ISO IDMP. IDMP was created to enhance and standardise pharmacovigilance activities and for us, it is natural to be at the forefront of this project. The project and its objectives have evolved with time, to such an extent that IDMP will now impact the entire lifecycle of the medicinal products (human and veterinary) once fully operational.

Whilst ISO IDMP is still a few years away from its complete implementation, Panacea is using our current PV and XEVMPD knowledge to stay ahead of the curve. We can see that this project will improve the protection of public health in the EU and hope you will find this update useful for this important step in our industry.

The EMA has decided on a Master data approach for the ISO IDMP called SPOR (Substance, Product, Organisation and Referential). The main goal of SPOR is to have everything (from clinical trials to the application forms and the CESP portal) integrated with this huge database. However, the full implementation will take some time to happen.

A staggered approach will be taken by the EMA with some elements being released sooner (as early as December 2016) and others much later on. The idea behind this is to learn from each step and provide a chance to industry to get used to this new system slowly. The integration with other services (such as application forms and submission portals) will also happen gradually.

A new database will be created with the SPOR data, but the data currently held in XEVMPD will be used to populate this, so, in theory, it will not be necessary to re-insert data already submitted via the XEVPD system. However MAHs will need to check this data and updated it as necessary.

The Referential management service (e.g. dosage, pharmaceutical forms, country codes, package codes, weight codes) and the organisation’s management services (data, providing the contact details of organisations and individuals responsible for various aspects of a medicines – which will include QPPVs) will be the first to be released. Once these services are in place, stakeholders should start preparations to replace their current data submission format, the eXtended EudraVigilance Product Report Message (XEVPRM) format, with the HL7 SPL format based on the ISO IDMP standards, ISO IDMP technical specifications and HL7 Common Product Model.

Precisely how this transition is going to be done and what is involved with the HL7 SPL format, should become clearer on the next few months when guidance documents, best practice and some training sessions from the EMA will be available. However, it is important to say that process changes do not start immediately at go-live.

For now, the only preparation needed is for companies to identify their master data and to tidy it up as much as possible in-line with the ISO standard terms already published (for example standardising how pharmaceutical form, different container closure systems, etc. are represented) .

Once the data is published in December, MAHs will need to check the published data and notify the EMA of any changes required.

The EMA has also introduced the ‘industry liaisons’ which are organisations such the AESGP (Association of the European Self-Medication Industry) or the EFPIA (European Federation of Pharmaceutical Industries and Associations) which are involved with the EMA SPOR task force. Unfortunately, there is not an organisation specifically for Generics yet, but it was hinted in by the EMA that this would come soon. Any questions on the SPOR approach and implementation can be raised with these organisations.

If you would like to discuss your implementation strategy for the upcoming ISO IDMP/SPOR processes in more detail, please contact Clarisse Ceotto on +44 1624 672777 or Clarisse.ceotto@panacea.im.

Team Panacea completes The Children’s Centre ‘Race the Sun 2016’

RTS Header

 

Race the Sun is a relay race like no other. The task is simple; starting at sun rise each team must complete a clockwise lap of the dramatic 98 mile Island coastal footpath before the sun sets. Split into 10 demanding sections, the course follows the Raad ny Foillan, a stunning coastal footpath with a significant height gain of 14,500ft.

The day started at 05.20 and after 10 gruelling Legs, our team finished comfortably before sunset at 20:28. Team Panacea AKA “Get him to the Creek” raised over £1000 for The Isle of Man Children’s Centre.

Findings from EMA ‘PROTECT’ Project are improving benefit-risk monitoring of medicines

The key findings of the PROTECT project (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium project) have been published.

PROTECT is a collaborative European project that comprises a programme to address limitations of current methods in the field of pharmacoepidemiology and pharmacovigilance. To view a summary of the PROTECT key findings and recommendations document, click here to visit the EMA Website.

The results of the Research on Outcomes of Therapeutics by a European Consortium (PROTECT) project, are making a difference in the assessment of benefits and risks of medicines available for patients in Europe.

To visit the PROTECT website, click here

EMA Launches Priority Medicines Scheme (PRIME)

The European Medicines Agency (EMA) has launched its new PRIME (PRIority MEdicines) scheme to strengthen support to medicines that target an unmet medical need.

PRIME builds on the existing regulatory framework and available tools such as scientific advice and accelerated assessment. A PRIME medicine is expected to benefit from accelerated assessment at the time of an application for marketing authorisation.

For more information about the PRIME scheme, click here to visit the EMA website.

The development of the Extended EudraVigilance Medicinal Product Dictionary and how this has impacted and continues to impact on Marketing Authorisation Holders.

December 2001 the European Medicines Agency (EMA) launched EudraVigilance

In December 2001 the EMA launched EudraVigiliance (Regulation (EC) No. 726/2004). This regulation is also known as Article 57 as it is the 57th article in legislation. EudraVigilance is a data management system designed to assist with data processing and evaluation activities during development and post marketing of medicinal products authorised in the European Economic Association (EEA). EudraVigilance has two main reporting functionalities.

Firstly it is used as a gateway to submit information on suspected adverse drug reactions. EudraVigilance allows users to pass details of adverse reaction reports electronically between the European Medicines Agency (EMA), Competent Authorities (CAs) and Marketing Authorisation Holder’s (MAHs) helping to improve the detection and assessment of signals.

The second key functionality of Eudravigilance is for the submission of information on medicinal products which creates a live product dictionary. In this article, I will focus on the Extended EurdraVigilance Medicinal Product Dictionary.

2005 EudraVigilance Medicinal Product Dictionary (EVMPD) was created

In 2005 the EudraVigilance Medicinal Product Dictionary was created by the EMA. EVMPD was created to establish a list of all human products authorised within the EEA. This information helps to assist with pharmacovigilance and regulatory activities with the aim of improving the processing and management of product information. An example of the use of this data is in the calculation of the mandatory PV fees. Since 2005 MAHs have been able to submit details of their products through EVMPD to the EMA, although this process was not initially mandatory.

December 2010 Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) was created and became a mandatory requirement

In December 2010 the original legislation (Regulation (EU) No. 1235/2010) was amended in the EU. Becoming article 57(2). The changes in legalisation led to EVMPD (EudraVigilance Medicinal Product Dictionary) being re-branded as XEVMPD (Extended EudraVigilance Medicinal Product Dictionary). This rebrand to XEVMPD was to reflect the further information which was now required for MAHs to submit and to also highlight the significant changes to legislation. Until this time EVMPD had been an optional requirement, but with the updated pharmacovigilance legislation, XEVMPD became a mandatory requirement for MAHs. Changes to the legislation included the submission of product information for each marketing authorisation becoming a mandatory process for MAHs by the 2nd of July 2012. Further changes included MAHs having a responsibility to keep their product information up to date as well as submitting further information on their products than what was outlined in the original guidance. For example, information being provided on excipients as well as providing a copy of the SmPC with each upload. The EMA outlined in the legislation that the information provided through XEVMPD would allow a list of all authorised medicinal products in the EU to be created.

Legal Notice on the Implementation of Article 57(2) of Regulation (EC) No. 726/2004

Following on from the July 2012 deadline, the EMA ran quality checks on product information which had been uploaded to XEVMPD. The validation of information showed many errors within the information provided, such as duplication of excipients, incorrect terms and incorrect active substances being selected. To improve the quality of information the EMA released the legal notice on the Implementation of Article 57(2) of Regulation (EC) No. 726/2004. This notice detailed that MAHs had to review their product information within XEVMPD and submit further mandatory information on their products by 31st  December 2014. Another key change outlined in this guidance was the implementation of timelines for specific regulatory events. MAHs are required to submit information on new marketing authorisations within 15 calendar days of date of marketing authorisation approval. MAHs are also required to provide information following variation, transfer, renewal, suspension, revocation or withdrawal of the marketing authorisation information within 30 calendar days.

Following on from the 31st December deadline, MAHs are required to comply with the set guidelines. The improvement of data within XEVMPD is a process which will help to benefit users. The information provided to EudraVigilance will support key pharmacovigilance and regulatory activities such as:

  • Coding of product information reported in adverse event case reports and helping to support and identify new safety concerns
  • Helping to support regulatory decisions and actions such as referral procedures and the establishment of Periodic Safety Update Reports time frames and literature monitoring
  • Calculating pharmacovigilance fees
  • Helping to improve transparency and communication with the Agency’s stakeholders by providing access to safety data information on medicinal products.

2016 Introduction of International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP)

Following on from the Article 57(2) guidance, the next big change for EudraVigilance and XEVMPD is the implementation of ISO IDMP. The EMA plan to release the EU implementation guide by July 2016 and begin preparation for electronic submission of product information by Q1 2017.The ISO IDMP establishes data elements which will help with the identification and will assist with the exchange of information on medicines helping to simplify the exchange of information between competent authorities. It will also help in supporting healthcare authorities in the development of electronic health records. In order to be best prepared for the next transition phase it is crucial to comply with the timeframes and standards outlined in article (57)2. Due to the nature of data entered into XEVMPD, here at Panacea (www.panacea.im), our Regulatory Affairs team is responsible for our clients’ XEVMPD. Our Regulatory Affairs team will also receive input from our Pharmacovigilance team; for example to ensure all indications are coded using the correct MedDRA terms, helping to ensure our clients’ data is kept to the high standards required. Our Regulatory Affairs team is well trained in this area, having worked on XEVMPD since it became mandatory in 2012. Team members have attended the official EMA course, passed the required XEVMPD knowledge exam as well as completed the online XEVMPD e-learning course. In the upcoming months our RA team will be closely monitoring any information released on ISO IDMP as part of our weekly Regulatory Intelligence checks, to ensure that we are up to date and prepared for the next transition phase. If you have any questions or would like to get in touch for support with XEVMPD work please get in touch at Martha.Manini@panacea.im

References:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000336.jsp

https://eudravigilance.ema.europa.eu/human/evMpd01.asp

Panacea Continue Sponsorship of the Company of the Year Award at Global Generics & Biosimilars Awards 2015

Panacea Chairman Stuart Colligon (right) presents the ‘Company of the Year’ award alongside Alan Dedicoat (left)

After the success of the inaugural event last year, Panacea continued its sponsorship of the Company of the Year Award at the Global Generics and Biosimilars Awards 2015. The Ceremony was presented by Alan Dedicoat – more commonly known as the “Voice of the Balls” – and is aimed at rewarding ‘best practice’ in both the Generic and Biosimilar Industries.

The award, won by Sandoz, was presented on the night by Panacea’s Chairman Stuart Colligon who commented:

“We are delighted to support this excellent, and fast growing, awards programme for another year. The organisers, Generics Bulletin, has been at the heart of the generic pharmaceutical industry for many years and we are thrilled to be associated with them. Panacea is all about quality of service and technical excellence. It was, therefore, the most natural and obvious choice for us the choose the Company of the Year award. I would like to congratulate all the nominees and the deserving winners, Sandoz.”

SC-Sandoz

Panacea Chairman Stuart Colligon (left) alongside Award Winners Sandoz

The awards coincide with the annual CPhI conference; one of the largest events on the pharma calendar. Attended for the fifth year in a row by Panacea, the exhibition is a unique opportunity to get a detailed understanding of the latest industry developments, and market news via a number of seminars and briefings. The expo also provided a perfect opportunity for meeting with existing clients and to network with some of the additional 36,000 pharma professionals in attendance.

Sam Tipper – Business Development Manager

Panacea Business Development Manager Sam Tipper at the Awards Ceremony

With the location of CPhI Worldwide 2016 already confirmed for the first time as Barcelona, Panacea are looking forward to attending this new venue next year.

Compulsory use of Electronic Application Forms (eAFs) for Medicines Licence Submissions

Since July 2015, it has been mandatory to submit applications using electronic application forms (eAFs) for marketing authorisations through the centralised procedure. From the beginning of 2016, it will become mandatory for all other procedure types, including national procedures. All other Medicines and Healthcare products Regulatory Agency (MHRA) submission requirements remain unchanged.

Click here to view guidance from the EMA