Thousands of drugs at risk if no Brexit deal, European pharmaceutical companies warn

Brexit threatens the free flow of these goods, given stringent medicine regulations that may require the retesting of drugs shipped across borders in the absence of an agreed trading arrangement.

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Supplies of thousands of medicines are at risk of disruption if Britain leaves the European Union without a trade deal, European pharmaceutical companies warned on Thursday. More than 2,600 drugs have some stage of manufacture in Britain and 45 million patient packs are supplied from the UK to other European countries each month, while another 37 million flow in the opposite direction. Brexit threatens the free flow of these goods, given stringent medicine regulations that may require the retesting of drugs shipped across borders in the absence of an agreed trading arrangement.

The European Federation of Pharmaceutical Industries and Associations (Efpia) said a survey of its members showed 45 percent of companies expected trade delays if Britain and Europe fell back onto World Trade Organization rules after Brexit. Drugmakers also face an additional hurdle when it comes to licensing their products, since more than 12,000 medicines will require a separate UK licence in order for them to be prescribed. “For life-saving and life-improving medicines, the EU and UK cannot afford to wait any longer to ensure that the necessary cooperation on medicines is in place from the day the UK leaves the EU,” said Efpia Director General Nathalie Moll.

Pharmaceutical companies have insisted since last year’s Brexit referendum that a comprehensive agreement is needed to ensure maximum alignment between EU and British pharmaceutical regulations. But with the clock ticking down to Brexit in March 2019 with no sign yet that a trade deal will be concluded, many companies are now starting to draw up plans to protect drug supply chains, including building extra testing centres in Europe.

 

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RPS says pharmacists must always be present in pharmacies

The three RPS national boards have jointly called for legal guarantees that a pharmacist will always undertake a clinical assessment or check, and that there must be no legal loopholes that can bypass this requirement.

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Source: Alamy.com

The leaked document, prepared by a working group of the Department of Health’s Rebalancing Medicines Legislation and Pharmacy Regulation Programme Board, suggested that current legislation could be changed to allow a registered pharmacy professional, which could include a technician, to take responsibility for the sale and supply of pharmacy and prescription-only medicines.

The Royal Pharmaceutical Society (RPS) has said it believes a pharmacist should always be present in a pharmacy, apart from occasional short periods of time.

Responding to a leaked document produced for the Department of Health (DH) on the issue of whether pharmacy technicians should be allowed to supervise pharmacies, the RPS has issued an eight-point position statement on the role of registered technicians supervising the sale and supply of medicines.

Read More: http://snip.ly/3pujp#http://www.pharmaceutical-journal.com/news-and-analysis/news/rps-says-pharmacists-must-always-be-present-in-pharmacies/20203609.article

Pharmaceutical companies gave $12m to doctors, nurses and pharmacists

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Pharmaceutical companies gave Australian doctors, nurses and pharmacists almost $12m in fees and expenses to attend conferences and give talks between November 2016 and April 2017.

The payments comprised more than $6.5m for travel expenses and accommodation; more than $4.2m in speaking and consultancy fees; and more than $700,000 to cover registration at medical conferences and events.

The drug companies Bristol-Myers Squibb and Amgen both spent more than $1m over the six months and one doctor received more than $39,000.

Health economists Prof Philip Clarke from the University of Melbourne and Dr Barbara de Graaff from the Menzies Institute for Medical Research in Tasmania conducted an analysis for Guardian Australia on the $11,667,253 in pharmaceutical payments made to healthcare professionals.

Under the updated Medicines Australia code of conduct, pharmaceutical companies were required to disclose all payments made to healthcare professionals by 29 August. Previously, this disclosure required the consent of the health practitioners, which in many cases

 

Read More information: http://snip.ly/mulqf#https://www.theguardian.com/australia-news/2017/sep/12/pharmaceutical-companies-gave-12m-to-doctors-nurses-and-pharmacists

CURE Pharmaceutical Launches New Academic Partnership Program Providing the Company’s Proprietary CureFilm™ for More Humane and Effective Animal Research

OXNARD, Calif., Sept. 06, 2017 (GLOBE NEWSWIRE) — CURE Pharmaceutical (OTCQB:CURR), (“CURE”), a leading disruptive drug delivery technology company, today announced the launch of a new academic partnership program, CureDotsTM. Under the CureDotsTMprogram, academic institutions may access the Company’s patented, multilayer oral thin film (OTF), CureFilm Oral™, for more humane and effective animal research and testing. CureDotsTM are punch-hole dot size versions of CureFilm Oral™ appropriate for pre-clinical testing with smaller animals such as mice.

Translation of a drug to human clinical trials requires that safety and efficacy studies be performed in animal models using the intended clinical route of administration, which is the oral route for many drugs. Oral gavage is the standard method for consistent and precise delivery of an investigational agent to an animal. However, oral gavage is often not well tolerated by the animal causing stress, which can jeopardize the integrity of the experiment.

According to published research by the University of Southern California School of Pharmacy, “Utilizing an Orally Dissolving Strip for Pharmacological and Toxicological Studies: A Simple and Humane Alternative to Oral Gavage for Animals,” preclinical, oral drug delivery using the CureDotsTM represents a safe, convenient, and humane alternative to oral gavage for repetitive pharmacological and toxicological testing performed on animals.

 

Read More: http://snip.ly/sp598#http://markets.businessinsider.com/news/stocks/CURE-Pharmaceutical-Launches-New-Academic-Partnership-Program-Providing-the-Company-s-Proprietary-CureFilm-for-More-Humane-and-Effective-Animal-Research-1002345676

US pharmaceutical company expands Dublin presence

US pharmaceutical company expands Dublin presence

PTC Therapeutics, a US pharmaceutical company, plans to expand its European headquarters in Dublin to 40 staff.

The Dublin site of the company is responsible for finance, quality assurance, legal and a raft of other back office roles.

“We currently employ 30 people in the Dublin office and this will increase to a total of 40 sustainable jobs in this office within a short period of time,” said Adrian Haigh, who heads up the company’s international operations.

PTC focuses on the discovery and commercialisation of novel medicines. It has been working on the development of a drug called Translarna for almost 20 years. The drug is the only protein restoration therapy for the treatment of nonsense mutation Duchenne Muscular Dystrophy – a genetic disorder characterised by progressive muscle degeneration.

 

Read More: http://snip.ly/qmou7#https://www.irishtimes.com/business/health-pharma/us-pharmaceutical-company-expands-dublin-presence-1.3212652

GlobalCompliancePanel announces Seasonal offers for Professionals with Flat 50% OFF on all Seminars

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Do celebrations need a cause and a reason? Yes, and GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, is having a solid cause and reason for doing so. It is celebrating the many years of its relationship with its customers spread all over the world by offering its trainings at a massive 50% discount!

Yes, that is right. GlobalCompliancePanel’s seminars will be available for a huge 50% discount till April 30. Regulatory professionals who want to augment their knowledge of regulatory compliance can now do so by paying just half the price of these trainings from GlobalCompliancePanel. All that is needed to do walk away with a rare offer such as this is to visit https://www.globalcompliancepanel.com/seminar?wordpress_SEO and use MGCP50 Promo Code.

This offer is valid till April 30, 2017. Regulatory professionals who want to take any of GlobalCompliancePanel’s trainings can book their trainings for an area of their interest by this date. From April 1 onwards, this offer will cease, meaning that the original price will apply from then.

So, why is GlobalCompliancePanel offering this discount? It is for a simple, but profound reason: It wants to thank its huge customer base for the support they have been extending to this company over the many years for which it has been in business. During the course of the 10 years for which GlobalCompliancePanel has been in business, it has trained thousands of regulatory compliance professionals from around the world.

These professionals, belonging to such varied geographies as the US and Japan and India and Canada, have been able to meet their regulatory compliance challenges on account of these trainings. These trainings are relevant, focused and valuable, and are from some of the best known regulatory compliance Experts found anywhere on this planet.

It is these trainings that have been hoping these professionals in the regulatory compliance arena gain more insights into regulations from the FDA, the EMA and other such bodies around the world. These trainings have been consistently helping them to meet these challenges, as they give them a better and sharper understanding of the implementing these requirements.

These regulatory requirements can pose hurdles to the most experienced and brightest of regulatory compliance professionals in the medical devices, pharmaceutical, life sciences and food and biologicals areas, but not to those who undertake professional trainings from GlobalCompliancePanel. GlobalCompliancePanel’s panel of experts is here to help them overcome these challenges and hurdles.

This trend has been being witnessed from the time GlobalCompliancePanel entered the line of professional trainings. Any wonder then, that no fewer than 50,000 professionals have benefited from these trainings? What could be a better way of thanking such a huge base of customers than with this offer? GlobalCompliancePanel believes that a celebration should also be useful, and this is that this offer is!

Hurry up and enroll today. Happy learning!

 

 

Investigations in Pharmaceutical Water Systems

nvestigations in pharmaceutical water systems are very critical for pharmaceutical organizations and laboratories. They can mean the difference between compliance and noncompliance. In many cases, organizations can get hauled up by regulatory authorities for failing to carry out proper investigations into pharmaceutical water systems.

The most common problem encountered by pharmaceutical and biotech companies and laboratories is microbial excursions. Investigating and handling excursions is the key to success in pharmaceutical water systems investigations.

Understanding excursions

So, what are water systems microbial excursions, and why do they appear so intimidating? In the simplest terms, microbial excursions may be defined as environmental data that is at par with or above established action limits for the regulated area. This means that in samples of water that fail to pass excursion tests, there is a certain level of contamination of the water systems in pharmaceutical and biotech organizations. Of course, it has to be borne in mind that the purity expectations and requirements are quite high compared to the water normally used by humans.

Why this is so is that pharmaceutical water systems are those that are used in the manufacture of drugs and pharmaceuticals; hence, even a small deviation from the prescribed levels of purity can have a major impact on the final outcome –the drug quality.

What can be done about excursions, then?

Having said this, excursions are not necessarily evil. Understanding whether excursions are from water, soil or from humans gives a good indication of the nature of excursions, which in turn give researchers a good idea of the nature of problems in the environment around them.

In many cases, wrongly designated trigger values, use points or wrongly selected and executed sampling and testing –and seldom excursions in themselves –are the culprit. So, pharmaceutical water systems and biotechnology organizations, laboratories and utility operations need to get their sampling right if they have to get to the root of the problem. This will help them avoid the huge costs associated with wrongly carried out investigations into pharmaceutical water systems.

 

References:

http://www.who.int/water_sanitation_health/emerging/info_sheet_pharmaceuticals/en/

http://electroiq.com/blog/2003/03/a-practical-guide-to-the-investigation-of-microbial-excursions/