Online Regulatory Compliance Training, FDA, Risk, and Compliance

Thursday, 9 November 2017

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.

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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Labels: change control in pharmaceutical industry, fda pharmaceutical water systems, Medical Device; Pharmaceutical Courses

Tuesday, 12 September 2017

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

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

Labels: change control in pharmaceutical industry, difference between pharmaceutical and medical device, Medical Device; Pharmaceutical Courses

Thursday, 7 September 2017

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, CureDots^TM. Under the CureDots^TMprogram, academic institutions may access the Company’s patented, multilayer oral thin film (OTF), CureFilm Oral™, for more humane and effective animal research and testing. CureDots^TM 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 CureDots^TM 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

Labels: fda pharmaceutical water systems, Medical Device; Pharmaceutical Courses, pharmaceutical, pharmaceutical clinical trials

Sunday, 13 August 2017

Enroll for FDA, Medical Device; Pharmaceutical Courses Just $10 each

Well, you can spend $10 to do a number of things. You can have a cup of coffee for you and your friend. You can buy an ice-cream each to two of your kids. You could buy them a couple of comic books. Or, you could choose to grow up in your profession. Wait a minute. Is there something wrong with the last of these options? Growing up in one’s profession? For $10? Yes, you are reading this right. It is neither a typo nor the height of exaggeration. Growing up in one’s career by enrolling for an FDA, medical device or pharmaceutical course for $ 10 each is a possibility. In this place and time. GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, makes this possible!

Want to confirm if this is true? Please log on to GlobalCompliancePanel’s website to check on the dozens of recorded webinars that are available for all of $10. The original cost of these webinars is $ 265. So, what does this mean? It means that you have a jaw-dropping discount of 95% on each of these FDA, medical device or pharmaceutical courses. Can anything be sweeter to hear for a Regulatory Affairs professional?

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A look at some of these webinars:

FDA:

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Medical Device:

Medical device companies are up against a slew of regulations from the FDA, EMA, and other regulatory agencies. They cannot get any of these wrong, if they have to meet the requirements and market their products and stay in the market. At this course, GlobalCompliancePanel equips them with everything they need to understand about the European Union released directive 2007/47/EC (amending Council Directive 90/385/EEC).

Pharmaceutical:

Harmonization with the ICH-Q10 is very essential for a pharmaceutical company’s Quality System. The FDA aims to promote a pharmaceutical Quality System to build on the 21 CFR 820 it formulated in 1996. Participants can gain complete understanding of this topic by enrolling for this webinar from GlobalCompliancePanel.