Biotech and Pharmaceutical Courses are a gateway to a challenging and flourishing career

With over four million employed directly or in allied sectors and catering to the world’s largest market and research area, biotech and pharma is a fast growing industry. Its courses are designed to prepare individuals for this giant industry.
Biotech and pharmaceutical courses are much sought after by aspiring professionals in the field of biotech and pharma. This is why:

• The US is the world’s largest market for pharmaceuticals, as well as being the world leader in biopharmaceutical research
• Research by Pharmaceutical Research and Manufacturers Association (PhRMA) has revealed that the majority of the world’s research and development (R & D) in pharmaceuticals is conducted by U.S. firms
• These firms hold the intellectual property (IP) rights on most new medicines.

Huge in every sense

Around 5,000 new medicines with approximately 3,400 compounds are currently being studied in the United States, the longest pipeline in any region in the world. The pharmaceutical industry employs nearly a million people and supports more than three times that number in related and supplementary industries. All these place a high demand on biotech and pharmaceutical courses.

What should those aspiring for courses look for?

Certification is the primary criterion to look out in those seeking a biotech and pharmaceutical courses. Whether it is classroom or online courses that are opted for; certification by a certifying authority should be the determining admission to biotech and pharmaceutical courses.
CFPIE or the Center for Professional Innovation and Education Inc., BioPharma Institute and Center for Professional Advancement (CFPA) are some of the better known providers of certified biotech and pharmaceutical courses. This is a partial list of the areas on which courses are offered by these institutes/centers:

The following tripod of software-related issues forms the IEC 62304:2006’s foundation: These three attributes form the backbone of the test of a medical device company’s successful compliance with the regulatory requirements. For a medical device company to be successful in applying ISO 14971:2012 and IEC 62304:2006; it has to implement a cross-standard and resourceful way of integrating activities covering these requirements documents.

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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

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

Making sense of the FDA’s GMP and Regulatory Expectations for Early IND Products

The FDA's recent guidance documents covering GMP requirements for Phase I products have considerably reduced some of the complexities early phase products face. These guidance documents are in addition to those that cover the CMC sections for IND submissions at Phase I.

Although these new guidelines appear to remove the need to follow GMPs for Phase I products; the same still exists in the Food, Drug, and Cosmetic Act. As a result, the need for GMP requirements for Phase I products has not been done away with; rather, it has been altered. Now, the nature and extent of GMP-related activities will depend upon the nature of the investigational drug and the extent of the study that is planned.

Get trained to understand these aspects

GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will be organizing a two-day seminar to help Directors, Managers and Supervisors in Regulatory Affairs, Quality Assurance and Quality Control get a grasp of these aspects. To enroll for this highly valuable training, please log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900695SEMINAR?GMP-regulatory-expectations-San-Diego. Steven S. Kuwahara, Founder and Principal, GXP BioTechnology LLC, will be the Director of this webinar.

Advice on the GMP guidance document

This presentation, which has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion, will review the GMP guidance document and discuss how it may be integrated with the recommendations of the guidance documents on CMC requirements. In one source, it will present the regulations and guidelines that apply to early phase products. In some cases these may not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. Steven will present these items in the order of product development from the point of R & D activities to the completion of Phase 2 clinical trials.

This course is very useful for any pharmaceutical personnel who must deal with products both in early and later phases of development, as it will make them aware of the regulatory requirements that will affect operations dealing with these products. The modifications to the GMPs for early phase products have altered the GMPs in such a way as to reduce requirements to allow more efficient work. At the same time, some of the things that may appear to have changed, have not, and personnel in the pharmaceutical sector should be aware of this. This is the learning that Steven will emphasize at this seminar.

It will cover the following areas:

o   Very Early Stages

o   GLP requirements

o   Early Pre-IND Studies

o   Meetings and Preparing for the IND

o   GMPs for Phase 1 IND products

o   Requirements for Phase 2 INDs

o   Preparing for IND Meetings 

Ensuring compliance with healthcare laws is of utmost importance for healthcare providers

Compliance with the many laws, as well as implementation of the necessary compliance initiatives are the means by which healthcare providers and entities or organizations involved in any type of healthcare transaction, especially those who bill or are involved with services payable by a CMS program, play a part in the protection of the integrity of  the CMS programs.

Developing and maintaining the necessary compliance programs that place a special emphasis on auditing and monitoring, appropriate training, receiving and responding to complaints and conducting investigations is necessary for providers, entities and organizations that bill Medicare, Medicaid or other government payor programs. Those whose compliance program fails to incorporate the necessary control processes risk inviting potential audits that could lead to civil, monetary and criminal penalties.

Understanding risks is necessary for healthcare practices

The ways by which to understand potential risks relating to their practice or organization and responding and mitigating deficiencies are all-important for healthcare organizations if they have to sustain their success and viability. This is also necessary if the organization has to avoid or neutralize the impact of negative findings by an external audit or investigative agency.

Moreover, with the many impactful changes taking place in the healthcare delivery; healthcare provider reimbursement could be affected. Quality of care and reduced costs will bring about changes into provider reimbursement for services. Healthcare providers have to understand how these changes are going to affect them.

Learning ways of implementing compliant programs

A two-day in person seminar by GlobalCompliancePanel, a highly reputable provider of professional trainings for all areas of regulatory compliance, will offer understanding on all these areas of healthcare compliance. This course, at which Gail Madison-Brown, a Registered Nurse and attorney who has spent over 25 years in the healthcare industry, and is Chief Clinical Trials Officer at UTHSCSA will be the Director,  will focus on ways by which healthcare organizations can devise means by which to stay compliant with the regulatory guidelines and laws.

To enroll for this seminar and to get a thorough understanding of how to implement practices that are compliant with regulatory requirements, just visit 

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900544SEMINAR?ensure-healthcare-compliance-Seattle-WA.

Ways of building a robust and pragmatic compliance program

Attending this seminar will help participants understand how to build a solid and practical compliance program. Gail will introduce the basic healthcare compliance infrastructure necessary to establish a comprehensive and proactive compliance program. She will then discuss current government auditing agencies and audits that are underway, as well as government agencies responsible for protecting the Medicare Trust Fund from fraud, waste and abuse.

She will teach participants the ways of identifying risks in their organizations, no matter what their size, by conducting a risk assessment and developing a work plan based upon risk and will help with the mitigation efforts. Apart from OCR audits and how to conduct their own self-assessment in preparation for an audit, as well as ways of addressing any identified deficiencies; participants will also learn how to conduct auditing and monitoring activities and what to do with findings. Ways of putting in place a complaint management system and conducting an investigation will also be discussed. The Director will also offer user friendly templates and tools, as well as numerous case scenarios to the participants, which they can use to enhance current compliance programs.

Cleaning validation should have a policy designed to meet harsh regulatory requirements and principles

Compliance with the required cleaning validation regulatory compliance guidelines set out by the regulatory authorities such as the FDA, WHO, PIC/S and EU is essential for those who work in facilities which involve cleaning.

The reason for which adherence to these regulatory guidelines is necessary is that these cleaning procedures need to establish and demonstrate verifiable standards of hygiene and safety. Quite naturally, cleaning validation regulations are built on highly rigorous, exhaustive and challenging principles.

Many approaches and requirements

Sound scientific principles and practices should be the basis for regulatory guidelines for cleaning validation. Cleaning validation, being risk based and reasonable, should consist of informed decision-making and thorough activity planning.

To comply with cleaning validation regulatory guidelines and scientific principles; very precise concepts such as how to determine the residues to be targeted, ways by which to select the right analytical and sampling methods, how to determine the appropriate limits in various pharmaceutical and biotechnology processes and knowing by what means to establish scientific rationales that are acceptable to regulatory inspectors, need to go into cleaning.

Lots of processes need to go into cleaning validation 

These concepts should ideally lead to the development of a general policy, i.e. a “Cleaning Validation Master Plan”, into which the appropriate documentation for each study needs to be performed. Awareness of the requirements for maintenance of the validated status is necessary for those in charge of the cleaning validation program. They have to also keep the regulatory requirements and the latest industry practices in mind.

Clarity on all these topics is the intent of a detailed, two-day learning session on the topic, “Regulatory Requirements and Principles for Cleaning Validation”, which is being organized by GlobalCompliancePanel, a well-known provider of regulatory compliance trainings. To participate in this seminar, simply log on to 

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900635SEMINAR?regulatory-requirements-Washington-DC. 

The Director of this learning session, Joy McElroy, Principal Consultant at Maynard Consulting Company, will clear all the doubts regarding cleaning validation and all its elements. Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification during the over 20 years of total experience she has had in the pharmaceutical and biotech industries, 12 of which have been as a consultant.

This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Implementing the 510 (K) correctly in compliance with the latest proposed FDA changes

A 510(K) is a premarket submission made to FDA to demonstrate that a device to be marketed is at least as safe and effective, meaning that which is substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA).

There are three types of Premarket Notification 510(K)’s that may be submitted to FDA: Traditional, Special, and Abbreviated. Product modifications that could significantly affect safety and effectiveness are subject to 510(K) submission requirements under 21 CFR 807 as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance with 21 CFR 820.30 Design Controls. The FDA provides guidance on these.

Needed: A thorough understanding of these aspects and the FDA’s latest proposed changes

In accordance with the concern evinced by many industry groups and associations, the FDA introduced as many as 60 proposals in August 2010, into the manner in which the 510 (K) process could be expedited. This was done with the intention of accelerating the speed at which newly approved medical devices could be made available to patients across the country. However, with the number of proposals being too many and their scope being too wide; the medical industry suggested that the FDA select for implementation only those proposals that enjoyed the broad consensus of the stakeholders, such as increased reviewer training, development of specific and relevant guidance documents, and enhancements or improvements to the de novo review pathway, among other suggestions.

An upcoming seminar by GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance industries, will clarify on these areas taken up for immediate change by the FDA and place them in the right context. It will address key resources when making critical decisions. This seminar will offer important insights into the core areas of premarket notifications, as well as the Design Control requirements under QS regulations and Design Controls.

To enroll for this seminar, just log on to

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900525SEMINAR?bullet-proof-510(k)-Seattle-WA

The Director at this seminar is David R. Dills, a senior Regulatory Affairs & Compliance Consultant. David provides regulatory, compliance and quality consultative services for medical device and pharmaceutical/combination manufacturers, and also has an accomplished record with more than 24 years of experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Regulatory Affairs, Compliance and Quality Systems.

An understanding of the core elements of the PMA

At this seminar, David will help participants understand how medical device manufacturers can locate a "predicate" device and go through the content and format of the 510(K), and offer an understanding of the De Novo process and the expectations for possibly marketing a low risk device, and the potential impact of FDA's proposed changes to the 510(K) process and why manufacturers need to pay attention to these.

He will also offer understanding of all the crucial aspects of the PMA, such as the differences between the Traditional, Special and Abbreviated submissions, an understanding of the Substantial Equivalence and how it is applied, who is required to submit the application to FDA, where to submit the 510(K) and what to expect with the review and approval process, when a device company requires this process and when it does not, the applicable exemptions to the submission process and special considerations, and so on.