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

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

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

Seminar Calendar of Upcoming Courses – June to July – 2017

seminars are a wonderful opportunity for professionals in the regulatory compliance

Upcoming-Courses-for-French-Circles-Club

GlobalCompliancePanel’s seminars are a wonderful opportunity for professionals in the regulatory compliance areas to understand the latest happenings and updates in the regulatory compliance areas and to implement them, something they need to climb in their professions. GlobalCompliancePanel brings together a few of the best recognized names in the field of regulatory compliance on its panel of experts. The result: Learning that is effective, valuable and helpful.

GlobalCompliancePanel’s experts help you unravel all the knowledge you need in all the areas of regulatory compliance. At these seminars which are held all over the globe, you get to interact with them in person, so that any doubt or clarification you have is sorted out by none other than the honcho. They help professionals like you implement the regulations and stay updated, so that regulatory compliance causes no stress for you.

GlobalCompliancePanel’s experts offer their insightful analysis into the issues that are of consequence to regulatory professionals in their daily work. Their thoughts help you implement the best practices of the industry into your work. They also offer updates on the latest regulatory requirements arising out of a host of the laws and issues related to regulatory compliance, including, but not limited to medical devices, food and beverages, pharmaceuticals, life sciences, biotechnology and pharmaceutical water systems.

Take a look at our upcoming webinars from GlobalCompliancePanel, which will put you on the road to learning about any area that is of importance to your profession. You can plan your learning from GlobalCompliancePanel by looking at our seminars in the next few weeks at locations of convenience to you. You can choose from a whole range of topics. See which among these trainings suit you: Design of Experiments (DOE) for Process Development and Validation, Writing and implementing effective SOP’s, new FSMA rules, risk management and device regulations, data integrity, combination products, and what have you!

Contact us today!
NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
Toll free: +1-800-447-9407
FAX : 302 288 6884
Website: http://bit.ly/Courses-June-to-July-2017

GMPs for API Bulk Manufacturers

Till recently, till 2001 that is, Good Manufacturing Practices for Active Pharmaceutical Ingredients (APIs) bulk manufacturers was carrying a bulky load on its shoulders, so to speak. GMP for active pharmaceutical ingredients (APIs) per se had no independent guidelines. The GMPs that they were to follow and implement were bunched with those of APIs for bulk manufacturers. So, GMPs for API bulk manufacturers consisted of GMPs for both APIs and API bulk manufacturer.

All that changed, however, in 2001, with the FDA’s issuance of a draft guideline called Q7A, which was meant separately and exclusively for APIs alone. This draft guideline was meant solely for APIs, and GMPs for API bulk manufacturers were exempt from the provisions of the new guideline.

No clear guideline yetThat said, while the FDA draft guidance of 2001 merely separated GMPs for APIs; it did not make any changes to the existing GMPs for API bulk manufacturers, which continued to remain the same and continued to suffer the same insufficiency. The major deficit that plagued GMPs for API bulk manufacturers continued to do so. As in the past, there was no guideline on GMPs for API bulk manufacturers at all. Instead, all that was required was that bulk manufacturers go by their heart. In other words, the onus of maintaining GMPs for API bulk manufacturers was left to them, based on their unique individual needs and situations.

Leaves it to the individual pharma organizationThe FDA and other regulatory bodies merely require that established practices be followed as GMPs for API bulk manufacturers. This, as noted, leaves the task of ensuring that conception and implementation of all-round GMPs for API bulk manufacturers to the individual organization, based on its discretion and assessment of what it deems as appropriate. The following are the areas into which pharmaceutical organizations may take steps at implementing GMPs for API bulk manufacturers:

  • Manufacturing equipment
  • Components that go into the materials and packaging
  • Requirements relating to record-keeping
  • Facilities and buildings
  • Personnel
  • Process controls
  • Laboratory controls

Learn more on this topic for your reference: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900964SEMINAR?Linkedin-SEO

Applied statistics for scientists and engineers

Applied statistics for scientists and engineers is necessary for a number of reasons. 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries specify the application of statistical methods for these functions:

o  Setting validation criteria and specifications

o  Performing Measurement Systems Analysis (MSA)

o  Conducting stability analysis

o  Using Design of Experiment (DOE) for process development and validation

o  Developing process control charts, and

o  Determining process capability indices.

Since scientists and engineers are at the heart of these functions, they need to have a thorough knowledge of how to use applied statistics. Each of these particular applications requires different and specified statistical methods. The common tools used for setting acceptance criteria and specifications are data and tolerance intervals, while for setting expiries and conducting stability analysis studies; simple linear regression and analysis-of-covariance (ANCOVA) are used.

For analyzing designed experiment for process development and validation studies, two-sample hypothesis tests, analysis-of-variance (ANOVA), regression, and ANCOVA are methods used, while for developing process control charts and developing process capability indices; descriptive statistics (distribution, summary statistics), run charts, and probability (distributions) are used.

Explaining the importance of applied statistics for scientists and engineers

A seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will explain the importance of applied statistics for scientists and engineers.

In the course of making the importance of applied statistics for scientists and engineers known; the Director at this seminar, Heath Rushing, who is the cofounder of Adsurgo and author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP, and has been an invited speaker on applicability of statistics for national and international conferences, will provide instruction on applied statistics for scientists and engineers and statistical methods for data analysis of applications related to the pharmaceutical, biopharmaceutical, and medical device industries.

To enroll for this highly valuable and practical course on applied statistics for scientists and engineers, just register by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900790?wordpress_SEO .

The course “Applied Statistics for Scientists and Engineers” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

The tools that help an understanding of applied statistics for scientists and engineers

This course on applied statistics for scientists and engineers will offer thorough instruction on how scientists and engineers need to apply the appropriate statistical approaches: descriptive statistics, data intervals, hypothesis testing, ANOVA, regression, ANCOVA, and model building. The Director will present the ways of establishing competence in each of these areas and industry-specific applications.

The application of statistical methods across the product quality lifecycle is specified in the 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries. There are many statistical methods that may be applied to satisfy this portion of the QSR. Yet, some commonly accepted methods can and should be used by all companies to:

o  Develop acceptance criteria

o  Ensure accurate and precise measurement systems

o  Fully characterize manufacturing processes

o  Monitor and control process results and

o  To select an appropriate number of samples.

At this seminar on applied statistics for scientists and engineers, Rushing will provide instruction on all these. He will cover the following areas over the two days of this seminar:

o  Describe and analyze the distribution of data

o  Develop summary statistics

o  Generate and analyze statistical intervals and hypothesis tests to make data-driven decisions

o  Describe the relationship between and among two or more factors or responses

o  Understand issues related to sampling and calculate appropriate sample sizes

o  Use statistical intervals to setting specifications/develop acceptance criteria

o  Use Measurement Systems Analysis (MSA) to estimate variance associated with: repeatability, intermediate precision, and reproducibility

o  Ensure your process is in (statistical) control and capable

Payroll laws are varied, hence need to be applied thoroughly and thoughtfully

 

Payroll laws set out the rules for which payroll regulations are to be enforced. Payroll laws and regulations have been enacted since it is through the payroll that employees not only get paid; it is also the same source for taxation and other deductions. Every organization that has a payroll system has to adhere to these payroll laws and regulations. The federal Department of Labor (DoL) sets out payroll laws and regulations, which the Internal Revenue Service (IRS) enforces. Payroll laws and regulations apply at the State and local levels.

Purpose of payroll laws

The fundamental function of payroll laws and regulations is to ensure that employers pay their employees the wages in accordance with the minimum wage limit set out by federal laws. Payroll laws and regulations are meant to ensure that employees do not get underpaid for their work.

The federal government makes a few deductions as part of payroll laws, while a few other kinds of deductions are levied by the States, and this rate varies from state to state. Ensuring compliance with the requisite payroll laws is an obligation on the part of employers who are bound by the provisions of the payroll laws. Employers who fail to do so invite legal action from the DoL.

In order to comply with the set payroll laws; professionals in charge of payroll functions in organizations need to have a complete and proper grasp of the way payroll laws are enacted. They need to be completely clear about the exact laws that they need to apply, the ways of doing so, the implications of not getting payroll laws right, and so on. All these will be part of a very valuable training session that GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, is organizing.

At this two-day seminar, Miles Hutchinson, who is President, Sales Tax Advisors, Inc., and is a CGMA and experienced businessman, who brings over 35 years in the field, will be the Director. To register for this important learning, please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900838SEMINAR?wordpress_seo .

Helping with an understanding of payroll laws in their entire depth

Miles will help participants augment their learning and understand how to handle their role with confidence. He will cover a very broad range of topics that includes:

  • Worker classification
  • Employee classification
  • Establishing methods and rates of pay
  • What must be included in the rate of pay
  • Hours that must be compensated as worked time
  • Required benefits
  • De Minimus working fringes
  • Withholdings and deductions from pay
  • Voluntary deductions
  • Child support and garnishment orders
  • Payroll reporting
  • Analysis of risks of noncompliance
  • Proper documentation of policies and procedures
  • Record retention requirements.

Understanding the sources of laws and knowing how to locate them

The core of this session on payroll laws is that it will help participants understand the sources at which they can locate the laws, how to interpret them and how to apply them in the most effective ways. This learning will give the participants the skill and knowledge they need to master the laws and identify the best practices that ensure compliance from their organization and out of court. This is a big money saver for sure.

Miles will help participants who are concerned about their company’s ability to comply with U.S. labor and payroll laws with a formal study of the rules of engagement. This will help ensure that their company pays their employees fairly and handles tax and other withholdings appropriately, as mandated by law.