WCI Thought Leadership White Paper News Feed

Turning Regulatory Requirements into Business Benefit

Wed, 13 Apr 2011 14:28:24 GMT

Product complaints are a fact of life. However, the pharmaceutical industry is unique; with its levels of regulation, complex nature of complaints, heightened customer expectations, and the product and process improvement opportunities that complaints offer. Whilst a number of industries have more complex regulations, none have the range of possible complainants; whether sophisticated and knowledgeable prescribers, or patients with, in some cases, little understanding between an Adverse Event and a product complaint.

Given the need to meet diverse regulations and a variety of complainants, the industry has simply settled for handling complaints as expeditiously as possible, without really looking for long-term product improvements, customer service opportunities, or on-going improvements to the complaints' handling process. Even the CAPA processes often drive a 'lip-service' attitude which fails to look deeply enough into complaints.

Typically, this has meant companies implementing a process that ticks the relevant local regulatory boxes and makes a basic attempt to correct on-going issues; rarely revisiting the process to ensure it is effective and operating at optimum cost. The best case scenario is that the same complaint is prevented from reoccurring, but underlying product issues are rarely addressed. The best method for future communication is not identified, and the prevention of similar issues in future products is not ensured.

So, how can companies make use of the complaint information and customer contact opportunities that a complaint provides?

To view the article in full, please click on the pdf link below:

turning regulatory requirements into business benefit.pdf

Why compliance isn't good enough

Wed, 13 Apr 2011 13:37:52 GMT

Surely there is no industry where quality is seen as more important than it is in Life Sciences. Indeed, hundreds of thousands of people are employed by regulatory authorities to enforce quality through compliance to regulations, with an increasing appetite to exact heavy penalties from those that do not comply. Yet it is possible to argue that, despite all their efforts, the regulators are failing to meet their goal. Pharmaceutical companies have to focus so much on regulatory compliance that it sometimes seems that they might not be grasping the true meaning of quality.

Customers, however, are not so easily distracted. Educated, with easy access to up-to-date knowledge, they treat medications much as they do any other consumer goods. Brand strength and recognition are increasingly important, especially now that generic competition to off-patent medication is increasing. Global media and information exchange provides marketing opportunities, but also puts the company's brand at significant risk in case of failures. Needless to say, the potential legal consequences of massive law suites caused by adverse events or quality defects remain a constant threat.

Compliance alone just isn't good enough anymore. There are recent examples that demonstrate that significant failures in Quality Systems and Oversight do occur, even in companies that have been at the forefront of defining regulatory compliance. Quality is not just about satisfying regulatory requirements, but meeting the requirements of all stakeholders, including customers and shareholders. Ironically, Quality Standards that facilitate this have been around for decades and are well established in other, less regulated industries. For example, the ISO 9000 family of standards was set in 1987, but its foundation dates even further back to the British Standards of 1979. Its first certification was awarded to a company within the highly competitive road construction business, not an organisation operating in a highly regulated environment at all!

To view the article in full, please click on the pdf link below:

Why Compliance Isn't Good Enough.pdf

How to achieve global supply chain oversight

Wed, 13 Apr 2011 14:33:57 GMT

Over the last decade the pharmaceutical industry has changed dramatically. The need to continue to reduce costs has resulted in the outsourcing of manufacturing, and increasingly complex supply chains. Globalisation has become a feature of the industry. The FDA reported that in the USA the number of foreign drug products and manufacturing sites doubled over the course of six years; involving many imports from countries with less developed regulatory systems. Between 2001 and 2007 the number of manufacturers in India increased by a factor of twenty five, and in China by a factor of seven.

The main challenge associated with the change is that functional organisations of pharmaceutical companies are simply not designed to deal with this degree of complexity. Supply Chains now run through too many different parts of the organisation, without having clear ownership established, or shared objectives for the overall process. Certain issues are not picked up because they fall between departments, increasing both the overall problem and the risk.

One direct result has been the increase in product recalls; up a staggering 400% between 2008 and 2009. Furthermore, ingredient adulteration has become a serious problem. Everyone in the industry is familiar with the recent cases of OSCS contamination in Heparin and the recurring contamination of Diethylene Glycol in Glycerin.

Due to the complexity, most companies struggle to gain full oversight of the supply chain. Given this lack of oversight, what level of confidence can a company truly have when releasing the end product to market? Are quality agreements in place with all suppliers? Are all suppliers regularly audited? Even if agreements are in place, it is unlikely that all the required information is available at the point of release.

To view the article in full, please click on the pdf link below:

How to achieve Global Supply Chain oversight.pdf

Safety First

Tue, 08 Mar 2011 12:41:58 GMT

The Challenges of Risk Management in Biopharmaceuticals

Unlike traditional small molecule drugs, every part of the clinical development, manufacturing, and prescription process for biopharmaceuticals has an important impact on the safety and risk profile of a drug. Identifying, collating and understanding all of the various drivers and their effect on drug safety presents challenges that are exaggerated or unique compared to traditional drugs.

For manufacturers, simply capturing relevant data to determine safety is difficult. It is even harder to apply this information to the risk management of current drugs than it is to traditional drugs. Extending this to future drug development with the aim to reduce risks and costs consequently becomes a challenge, which many companies have so far avoided.

However, lessons from other industries in risk management and traditional pharmacovigilance practices can be combined to produce more holistic processes.

To read the article in full, please click on the pdf link below:

Safety First the challenges of risk management in biopharmaceuticals.pdf

Keeping Your Balance

Tue, 08 Mar 2011 12:15:30 GMT

How lessons from the factory can optimise capacity in PV operations

Imagine that you are running a business-critical global process where the workload is steadily mounting, the pressure for improved productivity and efficiency is increasingly evident, and where the need to meet onerous compliance requirements is paramount. Nothing unusual in that you might think. But, what if you had no clear visibility of future workload, no exact handle on how many people were actually working for you, and little idea of how long it took them to complete their tasks? In that case, how would you know if you had enough people, or too many? Wandering around the office to have a look will only get you so far because most of your staff are working in other parts of the world and, besides, everyone always looks busy. They're clever, highly educated, and well motivated people too; surely they wouldn't be doing anything other than their very best, would they? Besides, you keep getting told by leaders, some of them anyway, that there simply aren't enough people to do the required work and that if you don't increase capacity soon you will fail to remain compliant with the regulatory timescales and then you'll be in trouble. Needless to say, your boss is unsympathetic and far from granting you extra resources is expecting you to cope with what you have. You suspect he'd actually like you to manage with even fewer people and you think he may be wondering if you're actually capable of doing this job in the first place. You're not sleeping well.

Welcome to the world of pharmacovigilance operations.

To read the article in full, please click on the pdf link below:

Keeping your Balance - How lessons from the factory can optimise capacity in PV operations.pdf

Improving Oversight and Management of Risks in your Global PV Operations

Tue, 08 Mar 2011 12:13:48 GMT

Implementing a process risk management system

This case study is focused on a project with an industry leading research based, top ten, pharmaceutical company. The company is continuously striving to improve their operations and have embraced the regulators expectation of a more risk based approach to ensure they always focus on the areas of greatest impact and value. With this ethos in mind, the company realised that there must be an opportunity to further enhance their PV operations through the application of risk management principles. A particular area of risk was perceived to be the PV operations of local affiliates around the world. Despite procedures and structures being in place to manage these operations, the central function could not be sure that the processes were being performed in alignment with their expectations. Historically, the only insight into local operations was via internal audits or regulatory inspections. However, it was deemed that these were too infrequent to ensure compliance. Therefore, the implementation of a process risk management system was identified as an ideal solution to provide oversight of global PV operations.

To view the case study in full, please click on the pdf link below:

Improving oversight and management of risks in your global pharmacovigilance operations.pdf

Sourcing Pharmacovigilance Activities - Strategic or Tactical Imperative?

Tue, 08 Mar 2011 12:44:23 GMT

A WCI survey looking at sourcing in the life science industry

Almost everyone has a point of view about the pros and cons of sourcing pharmacovigilance (PV) activities, but what is the actual utilisation of PV sourcing in industry, and what sourcing models are global organisations implementing now, and in the near term? This paper summarises the findings of a recent WCI survey which answers the aforementioned questions and also captures industry's experiences to date; valuable insight for organisations implementing a PV sourcing strategy.

Importantly, PV sourcing is not just about contracting with external service providers (e.g. BPOs or CROs) (outsourcing) but it is also about leveraging organisational operations owned by the sponsoring company (internal sourcing) which may be situated in low cost countries.

Currently, 70% of pharmaceutical organisations outsource at least one PV activity. This level is expected to increase to 80% by 2012. However, no clear pattern exists within industry of a common sourcing model dominating in the near term.

To read the findings of the survey in full, please click on the pdf link below:

PV Sourcing Strategic or Tactical imperative.pdf

Effectively and Efficiently Integrating Two Businesses to Realise the Merger Values

Tue, 08 Mar 2011 12:28:24 GMT

Integrating Global Drug Safety

Our client is a globally operating pharmaceutical company which, following a merger, is among the top 25 pharmaceutical companies in the world. They have a presence in most major markets and employ a significant workforce worldwide.

With any merger it is important to integrate businesses both speedily and effectively to ensure that the value behind the merger decision is quickly realised. In reality mergers can, and often are, difficult with research indicating that between 30 and 80 per cent fail to realise their value. Why? While money and effort often goes into re-engineering processes and integrating technology, too often change management and people issues are neglected. The very issues that will have a major impact on employees and, therefore, on the ultimate success of the merger, are not included in the merger plan; key issues such as the amalgamation of different cultures, the creation of a compelling vision for the future, the realignment of roles and responsibilities and the communication and engagement of all staff in the newly emerging business. The result is costly.

To read the case study in full, please click on the pdf link below:

Effectively and efficiently integrating two businesses to realise the merger values.pdf

What can sourcing do for Drug Safety?

Tue, 08 Mar 2011 12:47:34 GMT

Sourcing, when considered and approached correctly, can help to deliver the optimal solution

At a time of unprecedented change and with safety's workload increasing in both volume and scope, the question must be 'What can Sourcing do for Drug Safety?'

There is no shortage of evidence to suggest that more resources are, and will be, engaged in the business of safety as Adverse Event (AE) reporting rates continue to increase (26% average increase year on year since 2006) driving us to look throughout our organisations and beyond, for the capability we need to deliver what will be required of us. Inevitably, there is also clear evidence that ill-construed strategies, poor sourcing decisions, and poorly executed sourcing implementations can cause far greater problems than they can resolve.

Sourcing is not just about contracting with service providers to perform activities that could be conducted in-house (outsourcing). It is also about leveraging organisational operations owned by the sponsoring company (internal sourcing) which may be situated in low cost countries.

So, what can sourcing do for drug safety? Sourcing, when considered and approached correctly, can help to deliver the optimal solution; to ensure that patients and business alike, are protected. Or it can make a whole lot of trouble for us.

To read the article in full, please click on the pdf link below

What can sourcing do for Drug Safety?

Ensuring Compliance whilst Improving Operational Efficiency and Organisational Capability

Tue, 08 Mar 2011 12:29:46 GMT

Balancing performance and compliance we enable our clients to be more effective and efficient in drug safety

With in excess of 100 years in the industry our client is a leader in the development of long acting medicines. With a five year plan in place to grow and expand the business, following the significant downsizing that had been previously endured, our client first had to address the need for a comprehensive review of its Drug Safety and Pharmacovigilance processes, organisation and supporting technology.

From a process point of view, it was evident that AE case handling process at the organisation were stretched. Too many hand-offs and rework loops were adding to lead times and, as a result reducing compliance. There was also unnecessary duplication of effort involved with legal cases, giving rise to significant workload. The processes adopted by our client were not geared towards collecting quality incoming data that was 'right first time' and the process metrics and data in place did not enable easy root cause analysis and continuous improvement.

To read the case study in full, please click on the pdf link below:

Ensuring Compliance whilst improving operational efficiency and organisational capability.pdf

Bandaging Snowden's Leg?

Tue, 08 Mar 2011 12:18:58 GMT

Make no mistake, compliance matters

When a pharma CEO said “We'll be adding 250 new people to our Quality Assurance and Control organisation to address concerns identified by the FDA” he was 'bandaging Snowden's leg' – a syndrome (described in Heller' “Catch 22”) in which zealous attention is focused on a peripheral problem while life leaks away from an un-noticed, central trauma. In the book, Snowden dies. And the prognosis is not much better for a corporation which makes compliance its objective instead of getting down to the real needs of the business.

Compliance counts, but...

Make no mistake, compliance matters. Regulators enjoy rising public confidence, much of it fuelled by well publicised pharma failures. If you don't hit the mark, the consequences can be swift and severe. In the USA, the FDA can come in and take control. They'll make you comply, but what about a lasting solution to the problems?

If desperately chasing compliance is not the answer, then how do you stay compliant and raise business performance? Perhaps the place to start is by answering the question 'Why aren't we compliant anyway?'

To read the case study in full, please click on the pdf link below:

Bandaging Snowden's Leg

Taking the Risk out of Managing Change

Tue, 08 Mar 2011 12:45:38 GMT

Change is intended to strengthen companies, making them more competitive, and working more efficiently

Hardly a business day goes by without hearing the word 'change'. Change, apparently, is the only constant in our organisational lives; whether it is a major change linked to new strategic directions, or smaller ones coming from changing departmental work process. All of this change is intended to strengthen companies, making them more competitive and working more efficiently. Yet, research has shown that time and again, many change efforts fail to deliver the benefit that they promised.

There are many reasons cited, but they can all be boiled down to one thing. Usually the only focus is on the business solution - merging two organisations, implementing a major computer system, or adding new products to the portfolio. This can cost the company not only thousands, but millions of pounds. However, when it comes to thinking about effectively implementing this solution, many companies will not invest the same amount of effort or resources; and it is this which brings about the failure to deliver on benefits promised.

The answer is to invest in some effective change management, but for too many people in organisations this doesn't sound very tangible. What is it? Why should we do it? Isn't it expensive? Couldn't we just do some training? What returns will we get on our investment?

To read the article in full, please click on the pdf link below:

Taking the Risk out of change.pdf

GRMP: Good Risk Management Practice

Tue, 08 Mar 2011 12:11:30 GMT

Maximising the benefits of risk management across the business

GRMP is WCI's approach to maximising the benefits of risk management across the business and ensuring satisfaction of the emergent requirements of regulators. This is achieved through the application of a closed loop framework; ensuring the full cycle of risk is managed through to completion of actions and monitoring of effectiveness. The need to consider risks across a range of business activities is addressed by taking a holistic view of risk management throughout the product lifecycle, and applying this consistent best practice approach and methodology wherever risk management activities are being performed. The approach is based on the following key principles:

For risk management to deliver business value, there must be a focus on root causes and monitoring the effectiveness of actions to address risk
Risk Management processes across the business should be consistent and supported by a single governance structure
Risk Management is of value throughout the product lifecycle, with a need to shift focus on categories of risk over time.

To read the article in full, please click on the pdf link below:

Good Risk Management Practice.pdf

Shaping the Future of Pharmacovigilance

Wed, 13 Apr 2011 13:56:59 GMT

Networking to reduce risk

While drug safety can be a source of competitive advantage, there is a greater mutual benefit in sharing experience and common challenges. Drug safety people have many opportunities to network at a personal level and in an industry where there are numerous regulations and requirements that broaden and deepen on a daily basis, opportunities for debate with colleagues facing similar issues are vital. There are national and regulatory working groups that enable people to meet and discuss the changing regulations.

The conference circuit is another networking channel, however, although these avenues have proved invaluable for debating and creating a personal network, there is still a need to share actual data and compare detailed levels of activity. With a further need to share ideas on how to tackle the hot issues - rising costs, signal detection and risk management, discuss trends and benchmark performance. If you thought that you had a good process in a certain area, how could you be sure? A more proactive approach was needed. In response, in 2001 WCI founded pvnet.

To read the case study in full, please click on the pdf link below:

Shaping the future of pharmacovigilance.pdf

or visit the pvnet and pvconnect websites at pvnet.wcigroup.com and pvconnect.wcigroup.com

Tide of Change in Drug Safety?

Tue, 08 Mar 2011 13:13:48 GMT

There is a tide of change in the pharmaceutical industry with a push for drug safety to have a stronger role within clinical development. Taking drug safety operations from the reactive approach that dominates the industry to a more proactive stance is the right direction as drugs are now omnipresent in all facets of our lives. However, this does call for a huge cultural and technology shift in the world of drug development.

Distant Shores

Pharmaceutical companies have been under scrutiny due to highly public drugs failures such as Vioxx last year - the largest prescription drug withdrawal in history

Stakeholders are all concerned with how to identify Adverse Drug Reactions (ADRs) earlier in the product lifecycle, so that better decisions can be taken on their mitigation before the product reaches the marketplace.

To achieve this, drug development must be less reactive and more proactive. Which means that drug safety and clinical should be working in tandem, rather than as two distant spectrums of product development and marketplace monitoring.

To view the article in full, please click on the pdf link below:

Tide of change in drug safety.pdf

Bayer Clinical Trials Supplies

Tue, 08 Mar 2011 12:20:54 GMT

Less rush, means less risk

Clinical supplies is about delivering drugs to patients who participate in clinical trials. They are part of the critical stage in the development of a new drug that comes after the basic research, and before the launch.

This phase involves the manufacture and supply to clinical trials of small quantities of pills - placebos as well as experimental drugs with differing active strengths. These supplies have an absolute need for 100% control in order to ensure their validity. The single most important task for clinical supplies is to make sure the right patients get the right pills, at the right time.

To read the case study in full, please click on the pdf link below:

Bayer Clinical Trials Supplies.pdf

How to Build Risk Management into Clinical Trials

Tue, 08 Mar 2011 12:12:31 GMT

To err is human, to de-risk divine...

We live in an age where we wish to de-risk our investments. Today, in the highly competitive pharmaceutical sector, if you don't spot the risks before they become a danger to the patient, and a regulator can prove you had the information to mitigate them, you are liable to face one or more of the following: closure of your business unit, a prosecution case that could lead to a jail sentence, and personal responsibility for the serious illness or death of a patient. So far, so obvious, the need to de-risk.

Never before has it been so important for Clinical Trials teams to be alert for signals that point them in the direction of the possible risks. Clinical teams should avoid the trap of being locked into rules, regulations, and habits which means they are failing to pay attention to all available evidence about a trial or product which could be highlighting potential risks. This information comes from all types of sources. This can include insight that hint of potential problem areas in their product or trial design. However, because a Clinical Research Organisation (CRO), does not want to provide the sponsor with 'bad' news they may be tempted to ignore or gloss over concerns expressed by patients or doctors because they do not 'fit' protocol or the regulations. Sponsors need to actively encourage CROs to share all observations and finding.

To read this article in full, please click on the pdf link below:

How to build risk management into Clinical Trials.pdf

Managing Risk in Pharma and Compliance

Tue, 08 Mar 2011 12:31:26 GMT

Pharma has public responsibilities way beyond ordinary business ethics

The pharmaceutical industry continues to be rocked by a succession of blows which are forcing it to redesign its business models. Following on from the healthcare cost containment challenges in the '90s, the latest issues include a series of extremely high profile drug safety cases which are hitting public confidence and leading to regulatory transformation.

Previously, regulators had tried to keep control by inspecting the degree to which companies maintained compliance. A little bit like a school exam, if you managed to cover the right question on the day, you passed. As we all know, this doesn't always represent the full story, and this was also the case with the pharmaceutical industry. The regulators are now encouraging companies to design quality in at source, in a way which proves they are in control of their processes. The approach being taken is risk-based, which means the FDA and other like them will assess the degree of risk a company presents and hence the degree of rigour to which they will receive regulatory oversight. There is a new awareness that pharma has public responsibilities way beyond ordinary business ethics. Public safety is paramount.

To read the case study in full, please click on the pdf link below:

Managing Risk in Pharma and Compliance.pdf

Manage Risk, Manage the Regulator

Tue, 08 Mar 2011 12:16:34 GMT

Risk Management is the smart route to safety and to well aimed investment

In the increasingly competitive Life Sciences sector, spotting potential risks before they become a danger to the patient is a must and has just been enforced by new regulations (e.g. Volume 9a). So, how can life science companies both manage risk and manage the regulator?

The traditional approach of pure compliance to regulations using a typically paper heavy system will probably keep you on the right side of the regulators - but, will it help you to improve your processes? The public demands a demonstrable increase in safety. No wonder the regulators are looking for a new approach!

The traditional approach does not increase safety, so much as encourage risk. Nor does it deliver better or faster drug development - which ought to be on of the required outputs. The defect of the traditional approach is that, though it uses immense resources, it addresses the letter but not the spirit of the regulations. Yet the opportunities are there.

To read the article in full, please click on the pdf link below:

Manage risk manage the regulator.pdf

Pharmacovigilance for the Future

Tue, 08 Mar 2011 12:39:34 GMT

The process transformation achieved outstanding results

As the dust of mergers settled, AstraZeneca emerged assessing the impact of its marketing and development plans on pharmacovigilance. 'Dramatic' was the conclusion. In 2002, the Clinical Drug Safety team processed over 50,000 individual adverse event (AE) case reports globally. Broadly harmonised, but with a lot of local variation, the system funnelled reports worldwide from seven collecting sites in Europe and the USA to a central database. It worked. However, continuing growth in the products and drugs portfolio would take the annual case report figure well past the 10,000 mark by 2007. Growing a quality workforce to match was currently a fanciful notion. AstraZeneca's Clinical Drug Safety team decided they must re-engineer their case handling process to achieve the vast productivity increase approaching, whilst maintaining the highest quality.

To read the case study in full, please click on the pdf link below:

Pharmacovigilance for the Future.pdf

Developing Holistic Safety Risk Management

Tue, 08 Mar 2011 12:24:00 GMT

Traditionally the approach to drug safety has been focused on the reactive. Recent events have shown that this is not enough to ensure visibility of safety risks during clinical development

Life Science companies have public responsibilities beyond those of ordinary business ethics. Public safety is paramount and, in the context of drug development, it is important to make all reasonable efforts to understand the emerging benefit and risk profile of the product. This will not only ensure that the patients entering trials are protected, but that the risk of product failure is appropriately managed.

Recent drug withdrawals and failures to obtain approval have put both industry and regulators under pressure to improve safety surveillance during drug development. This has led to pressure to bring the safety risk management processes of pharmacovigilance into earlier phases of development, thus, making pharmacovigilance increasingly business critical.

To read the article in full, please click on the pdf link below:

Developing Holistic Safety Risk Management.pdf

Competitive Clinical Supplies

Tue, 08 Mar 2011 12:22:53 GMT

The opportunity and business imperative to develop innovative New Chemical Entities (NCEs)

The major shift in strategy has required fundamental cultural and organisational change. Schwarz moved quickly and developed four programmes in Phase II, and one in Phase III; a major achievement for an organisation so new to the demanding world of NCE development. However, it was clear that there were opportunities to improve efficiency and effectiveness. The systems that had been in place for product development were not as efficient or effective as they needed to be with the increasingly successful development pipeline. One of the areas where Schwarz Pharma recognised the need and has been able to improve in the last two years, to become truly competitive, is Clinical Trial Supplies (CTS).

In late 2002 Schwarz Pharma was planning another Phase III Clinical Trial. CTS was desperately short of capacity. Outsourcing seemed to be the answer, as has been the trend within many other pharmaceutical R&D organisations, but the cost of outsourcing was four times what had been originally budgeted.

To read the case study in full, please click on the pdf link below:

Competitive Clinical Supplies.pdf

Drug Safety Grows Up

Tue, 08 Mar 2011 12:26:23 GMT

Increased regulations and worried customers are just two of the factors driving trends in drug safety and risk management today. Examining the present situation, Deborah Gold at WCI Consulting Limited predicts a new, proactive pharmacovigilance environment for the future.

Heads of Pharmacovigilance (PV) are currently undergoing something of a rites of passage. In the youth of their careers the focus for their Drug Safety (DS) teams was compliance with operational regulations. And it worked. Most Drug Safety teams now have both their compliance and their basic operational processes well under control.

However, times and regulations are changing. The focus of the regulators has expanded to proving that DS teams have a structured approach to mitigating risk in place and, if not, they are ready to strong enforce the penalties.

Worried consumers, alarmed by media reports of Big Pharma's rumoured preference for profits over patient safety, are adding to the call for the industry to take a wider and more proactive approach to PV. The spotlight on safety is brighter than ever; and PV Heads are now required to take a more holistic view going forward, and find and develop opportunities for building safety into the wider drug development process.

To read the article in full, please click on the pdf link below:

Drug Safety Grows Up.pdf

Redefining the Safety Reporting System

Tue, 08 Mar 2011 12:40:40 GMT

Re-engineering adverse event processes

In early 1995, Zeneca Pharmaceuticals decided to re-engineer its flailing adverse event process. This was to become one of the most rigorous and effective applications of business process re-engineering to safety reporting procedures undertaken in the pharmaceutical industry.

Within Zeneca Pharmaceuticals, the Product Safety Group (PSG) is responsible for ensuring that safety data are collected and entered into the company's international database. In addition to the consequent and on-going evaluation of the safety profile of each medicinal product, PSG must produce information allowing Zeneca to meet regulatory requirements for the notification of suspected adverse drug reactions (ADRs) on an international basis. By early 1995, this procedure was showing signs of strain.

To read this case study in full, please click on the pdf link below:

Redefining the safety reporting system.pdf

What Compels a Company to Change Safety Database Systems?

Tue, 08 Mar 2011 12:07:09 GMT

WCI survey to gain better insight into the influencing factors

At the core of all pharmacovigilance organisations (PVOs) is the Safety Database (SDB) system used to capture, assess, and report Adverse Events (AEs) to regulatory authorities worldwide. Effective execution of AE processing, reporting to authorities, and the broader analysis essential to signal detection and risk management are heavily dependent on system functionality.

An evolving global regulatory environment is creating new challenges and business requirements, increasing the importance of system flexibility and vendor responsiveness.

SDB infrastructure consumes a significant share of the total investment in drug safety activities, and replacement has far-reaching organisational impact. An implementation on a medium/large scale will likely:

Cost $10-15+ million in capital expenditure
Require 35-40 fulltime equivalent staff for 18-24 months
Consume business and IT resources needed for day-to-day operations
Require extensive effort to engage stakeholders both internal and external to the PVO, as well as external to the business itself, such as license partners and affiliates.

What then, are the factors that compel a PVO to make a decision of such significance?

In January 2006, WCI conducted a survey of pharmaceutical and biotechnology organisations to gain better insight into the influencing factors.

To read the findings in full, please click on the pdf link below:

What Compels a Company to Change Safety Database Systems?

Good News - Regulations Just Got Tougher

Tue, 08 Mar 2011 12:08:44 GMT

It's good for the customer, it's good for the industry, and it deserves to be embraced wholeheartedly

Regulation aims to keep the public safe and the playing field level. We used to marginalise it, as an irksome extra task, its only function to satisfy the regulators. That was bad business, because compliance - being seen to do the right thing - doesn't come cheap. And, when you invest in any activity, you have to see added value. Today, most companies are integrating pharmacovigilance (PV) into the mainstream operation. It brings performance benefits, and compliance date comes out automatically. The industry is less defensive too: we've learned that when things go wrong, it's no good wriggling. We simply own up and fix it. But what's this? Just as we think we're sorted, the regulators (starting with the FDA) shift the goalposts. No, don't groan yet: wait until you've heard the plan!

To read this article in full, please click on the pdf link below:

Good News Regulations just got tougher.pdf

Networking to Reduce Risk

Tue, 08 Mar 2011 12:33:47 GMT

Whilst drug safety can be a source of competitive advantage, there is a greater mutual benefit in sharing experience and common challenges.

Pharmaceutical and biotech organisations carry the responsibility for their patient's safety. In these businesses, drug safety is a life critical process where these organisations are responsible for reporting and managing all adverse drug reactions, and associated risks. It's a highly regulated aspect of the business, with the EMEA and FDA watching over in Europe and the USA.

It's also one that is constantly changing. Not only has there been an increase in the number of adverse events and the complexity of new drugs, but new legislation is often introduced, and existing regulations are continually updated. Compliance is rigorously monitored and organisations are subject to reporting rules and audits. The price to pay for non-compliance is high - warning letters that risk the global reputation of the drug safety teams, and product withdrawal, which can cost the company millions of dollars and many staff jobs.

To read the article in full, please click on the pdf link below:

Networking to reduce risk.pdf

Drug Safety in Biotech

Tue, 08 Mar 2011 12:25:03 GMT

Fewer potential new drugs, fewer mass market opportunities, candidate drop out, declining returns...just some of today's pressures on life science companies. If only there was a way to solve the conundrum of maximising ROI as opportunities decline. Now, there is!

Under-used Asset

There is an asset all biotech companies have. It represents a large investment, and a few of them are exploiting it to the full. That asset is their investment in pharmacovigilance (PV). Integrate PV with your core activity, and you can produce developments that are easier to licence, swifter to market, quicker and more predictable in uptake, assuring your future funding.

Two key lessons emerge from all too well known industry mistakes. First, you need a 'fit for purpose' PV system to protect your portfolio asset. It must provide you with the date, from every possible AE source, that enables you to avert potential post launch disasters long before they happen. Secondly, your company must speak with one voice - a seamless, synchronous, global stance on all safety matters.

To read the article in full, please click on the pdf link below:

Drug Safety in Biotech.pdf

The first rule of pharma is to do no harm

Tue, 08 Mar 2011 13:10:08 GMT

PSURs can be seen as a time consuming exercise or as a positive step towards proactive pharmacovigilance. Chris Holmes explains how to stay one step ahead...

No-one likes reporting bad news, especially when it can lead to the withdrawal of a product. Equally, everyone knows it is better, particularly in pharmaceuticals, to play safe. This ambivalence is squared in most companies by simply doing what is required by law.

But, current regulations are not easy to comply with, and some firms are finding that it pays to be more proactive in their pharmacovigilance efforts. Bayer, for example, has taken the decision to compile Periodic Safety Update Report (PSURs) on 60 or so of its strategic drugs every six months, rather than adhere to the timetable of the regulatory authorities.

This decision has taken significant resources to implement, but it provides a continuous process of safety evaluation and a 60% reduction in the cost of producing each PSUR. The extra costs come from implementing 'smarter' drug safety processes to simplify activities, improve productivity, and provide better quality information to both the affiliate companies and the regulators.

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The first rule of pharma.pdf