Tue

24

May

2016

Drug Makers to Prepare for Pharmacovigilance Reforms in Russia and Other EAEU Countries

Drug companies operating in Russia and other Eurasian Economic Union (“EAEU”) countries are being advised to prepare for the new obligations and liabilities that an impending new regulation on pharmacovigilance in the EAEU might introduce for them.

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Wed

06

Jul

2011

European Medicines Agency listens to stakeholder expectations for pharmacovigilance reforms

The European Medicines Agency has hosted a second workshop on the changes to the safety-monitoring of medicines in Europe, where it heard the expectations from patients, consumer groups, healthcare professionals and the pharmaceutical industry.

 

The second stakeholder forum on the implementation of the new pharmacovigilance legislation, which took place on Friday 17 June, involved discussions between the Agency, key stakeholder groups and medicines regulatory authorities from the European Union (EU) Member States.

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Fri

01

Jul

2011

Potential and Capabilities of the Clinical Research Sector

Clinical research organisations, play an essential role within the drug development process. From large international firms, to smaller niche companies, clinical research organisations are relied upon by the pharmaceutical manufacturers to conduct clinical trials.

The patents due to expire on a number of blockbuster drugs in the coming months mean that the pharmaceutical industry is likely to refocus its drug development strategies.

With uncertainty still surrounding the global economy, drug manufacturers are likely to look to clinical research organisations to provide the expertise needed to get their products to market, in both a timely and safe manner.

Figures from Tufts Center for the Study of Drug Development show that clinical trials conducted by outside organisations are completed 30 per cent faster than those completed in-house.

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Thu

30

Jun

2011

Pharmaceutical Outsourcing, Where Do You Draw the Line?

The real issue in pharma is budget and structural change. There are no magic methods  to overcome what Richard Nelson called "the simple economics of basic scientific research—patents or no patents, capturing the value that ultimately derives from fundamental research is extraordinarily difficult for profit-oriented organisations. “The world is changing fast and pharma runs an outdated business model in “Novus Ordo Seclorum”, where budgets for pharmaceuticals are reframed within healthcare cost containment. Outsourcing seems to be the universal answer; however there is more to the answer than meets the eye.

 

Questions: The Probability of Serendipity; the Outdated Business Model and Approaches to Innovation; the Outsourcing Answer; What Core Competencies Remain As Hallmark of Pharma Companies?

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Thu

23

Jun

2011

Global Drug Safety and Risk Management

Reported adverse events are an important tool for implementing a risk management program. An important contributing factor in the evolved AEs the condition of chronically ill patients taking a drug daily over the course of many years. Another factor the large number of patients taking multiple prescriptions’ drugs all together, increasing the potential for drug-drug interactions. Its worth to mention that unlike the small, carefully selected, homogenous test groups in the conducted clinical trials, users of on-market drugs are highly heterogeneous, bringing a complex range of potential factors of diverse populations and race, physical condition and compliance.

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Wed

15

Jun

2011

Pharmacoepidemiology and Pharmacovigilance

Pharmacology is the study of the effects of drugs. The other interesting branch known as the “clinical pharmacology” is interested in the effects of drugs in humans by which therapy is individualised according to the needs of each patient (based on the nature of his disease and its severity). The epidemiology is study of distribution and determinants of diseases in populations.

Clinical pharmacology and epidemiology working together with their inputs and out comes resulted in the development of pharmacoepidemiology.

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Mon

30

May

2011

FDA Compliance: Minimising Risk

Compliance with Food and Drugs Administration (FDA) guidelines is essential for all working within the pharmaceutical industry, from researchers working on clinical trials to those marketing the drugs to members of the public.

The FDA is tasked with ensuring that all products for human consumption, and healthcare products, including medical devices, pose minimal threat to public safety, and those that fall foul of its guidelines can be dealt heavy penalties.

Regulation of over-the-counter drugs and prescription drugs is conducted by the Center for Drug Evaluation and Research, through the Office of Compliance, which uses policy, observation and enforcement to minimise "unnecessary risk from drugs throughout their lifecycle".

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Thu

19

May

2011

Russia: Localisation vs. Isolation - Part Two

Pharma2020 – Towards Self-Reliance or the WTO?

In late 2008, The Russian Federation’s Ministry of Industry and Trade announced the Pharma2020 strategy as part of the Healthcare Development Programme.

Although there were other aspects involved in Russia's broader pharmaceutical industry strategy, one goal was clear: Mr. Putin wishes to boost the domestic industry to make up at least 50% of total pharmaceutical expenditure. While the milestone is projected for 2020, this is hardly a minor objective: the domestic industry only made up approximately 19% of pharmaceutical expenditure in 2008.

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Fri

13

May

2011

Russia: Needs to Invest in Cold Chain Infrastructure for Biopharma to Grow

If Russia is to truly capitalise on this interest from big players within the pharmaceutical industry it will need to invest in its infrastructure, including its cold chain – an asset which will become ever more important as biopharmaceuticals develop. Even within the domestic market, the country is so vast and varied a wide number of logistical challenges are presented.

According to a recent report by Datamonitor entitled Russia Pharmaceutical Market Overview Pharma companies target Russia despite the challenges it presents,: "The Russian pharmaceutical market generated $10.1 billion in sales in 2009, growing by 14.5% between 2008 and 2009".

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Wed

11

May

2011

2010 In Review: Synopsis of Noteworthy FDA Approvals

The FDA approved 20 drugs of note in 2010. Most are pharmacologically similar to others already marketed (see Table 1). Among the remainder are two orphan drugs granted approval for Dupuytren disease and n-acetylglutamate synthase deficiency (see Table 2) and four "first-in-class" medicines for emergency contraception, lipodystrophy, multiple sclerosis, and rheumatoid arthritis (see Table 3). One new approval, eribulin, an antimitotic indicated for breast cancer, is the first drug derived from the sea sponge, Halichondria okadai, and only the third marketed drug to be derived from marine invertebrates[1] (see reference 1 for a discussion of the challenges of harvesting drugs from the sea).

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Fri

22

Apr

2011

2010 pharmacovigilance legislation: strengthening the monitoring of medicines

New pharmacovigilance legislation (a directive and a regulation) amending existing legislation was adopted in the European Union (EU) in December 2010. The legislation aims to save lives by strengthening the European-wide system for monitoring the safety of medicines.

 

The new legislation forms part of a three-piece ‘pharmaceutical package’ and amends existing pharmacovigilance legislation contained in Directive 2001/83/EC and Regulation (EC) No. 726/2004. The remaining parts concerning falsified medicines and information to patients have not yet been adopted by the European Parliament and the European Council.

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Tue

19

Apr

2011

EMA holds first stakeholder forum on the implementation of the new pharmacovigilance legislation

On 15 April 2011, the European Medicines Agency held a stakeholder forum on the implementation of the new pharmacovigilance legislation with a broad cross-section of participants including industry, patient and healthcare professional representatives and national medicines regulatory authorities.

 

This was the first in a series of stakeholder meetings taking place during 2011 and 2012, when the Agency aims to raise awareness of the requirements of the new legislation and promote the exchange of ideas, concerns and opinions.

 

During this first meeting, immediate feedback from stakeholders was received mainly in relation to the Agency's and Member States' technical contribution to draft European Commission implementing measures. Close co-ordination and co-operation with stakeholders will maximise the opportunities for a successful and efficient adoption of new requirements, which come into legal force in July 2012.

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Tue

29

Mar

2011

Orphan drug designation in the EU and the US

Pharmaceutical companies play the major role in the provision of medicines in the health systems of the EU and the US. Pharmaceutical firms are commercial enterprises which are in most cases public companies. When developing new medicines the companies invest a considerable amount of money and therefore, the market for a medicine needs to have a corresponding size to ensure the return of investment.

 

However, there are also diseases which only occur in a small group of patients, so call rare or orphan diseases, thus the market for medicines treating a rare disease is likewise small and the financial interest of companies in these diseases is as a consequence limited. To encourage the development of medicines for rare disease the EU member states and the USA have established programmes which provide incentives for companies developing orphan drugs.

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Fri

25

Mar

2011

What Is The Value Of Outsourcing?

Outsourcing can have its benefits, but how often do we bother to measure the actual value of our outsourcing relationships? Or the innovation that it delivers? In Europe, at least, the answer is: not very often.

 

This week, Warwick Business School (UK) released a study (sponsored by Cognizant) looking at European C-suite attitudes to outsourcing. The study encompassed 250 CIOs and CFOs across Benelux, France, Germany, Switzerland, the Nordics and the UK.

 

The majority of respondents (70%) say they believe that innovation achieved through outsourcing contributes to their company’s financial performance, but only 35% admit to measuring the innovation that their outsourcing partner delivers.

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Thu

24

Mar

2011

EMA launches clinical trial registry

The European Medicines Agency has launched an online registry which, for the first time, gives the public access to information on interventional clinical trials in the European Union that heretofore has only been available to the regulatory authorities in the member states.

 

The new registry can be found at www.clinicaltrialsregister.eu. It includes information on trials that have been authorised in the 27 EU member states as well as in Iceland, Liechtenstein and Norway.

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Tue

15

Mar

2011

Raising the Bar in Outsourcing

In recently attending several industry events, I heard a common theme from both pharmaceutical companies and their suppliers. The stakes for successfully managing the outsourced relationship have never been higher. For pharmaceutical companies seeking to optimize their external supply networks as part of their overall development and manufacturing strategies, and for contract service providers seeking to be part of that network, the bar is being raised. So what are the changing expectations and critical success factors in outsourcing?

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Wed

02

Mar

2011

Russia: Localisation vs. Isolation - Part One

The Rise of Russia: Not Just a BRIC Anymore

Five years ago, few pharmaceutical executives would have believed that 2011 would bring a feverish scramble to invest in Russia. At the time, many believed that Russia was to be considered a high potential emerging market worthy of the same breath as China, Brazil and India. However, the interest was always in the number of patients who could consume pharmaceutical product, and their associated evolution in ability to pay.

Perhaps not surprisingly, and in a very customarily Russian way, the government has masterfully created an international environment where refusal by foreign multinational pharmaceutical companies to make significant investments in the country will result indiminishment of revenue opportunities.

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