Regulations in the US and EU Dealing with Combination Products

Regulations in the US and EU Dealing with Combination Products.jpg

Registering and maintaining combination products in the US and the EU is a bit tricky, because these are disparate markets that are governed by different sets of regulations which are independent of each other. So, any business that wants to market combination products into the US or the EU must be completely aware of the nature and meaning of all the regulations. Such businesses need to understand the nuances of the regulatory expectations and do what it takes to meet these.

Professionals and organizations that work in these areas must familiarize themselves with the existing regulations and their latest updates. This is the foundation to ensuring that their products comply with regulatory requirements and meet quality standards, which ensures that the consumer consumes products that are of the set scientific standards.

The regulations in the two markets have evolved differently. The fact that the regulatory agencies in the two markets, namely the US FDA and the European Medicines Agency (EMA) work to ensure the quality of drugs and thus the wellbeing of their consumers is the commonality between the two.

While the US FDA is a centralized agency that regulates food and medicinal products across the vast US market; the EMA, synchronizes the regulations of the 28 countries that are members of the European Union. While the FDA was primarily created to be a consumer protection agency; the regulations from the EMA came about to harmonize the commercial and technological interests of the Member States.

The EU’s new update

Regulations in the US and EU Dealing with Combination Products 3.jpg

In September 2016, the EU, through its two major legislative organs -the European Commission and the European Council, reached a compromise on a major area concerning combination products. Reached four years after a deal was made; the compromise relates to medical devices and invitro diagnostic (IVD) devices.

High risk combination devices, such as implants, will from now be assessed and authorized by the EMA. Brought in to replace the existing EU legislation on medical devices and in-vitro diagnostics; the new regulation seeks to make these products more consistent and uniform in terms of their assessment and approval process across the EU.

Thorough and sound learning of the US and EU regulations on combination products

This is the case of just one regulation in the EU concerning combination products. When the regulations and their updates from both the US and the EU are taken together, a regulatory professional or anyone in manufacturing is up against a mountain. It is to help gain clarity on this wide array of topics that GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will be organizing a two-day seminar.

This seminar, which is aimed at giving professionals who work in areas concerning regulation in the combination products area, will have Salma Michor, founder and CEO of Michor Consulting Schweiz GmbH, as the Director.

Please visit Regulations in the US and EU Dealing with Combination Products to register for this seminar. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Clarity about combination products

Regulations in the US and EU Dealing with Combination Products 1.jpg

Over two days of intense learning, Salma will offer a thorough understanding of the complexities involved in the regulations about combination products in the EU and the US. She will offer in-depth explanation of all the relevant regulations and guidelines. She will reinforce this learning by offering real life examples of how to register and maintain various types of combination products.

Salma will also help participants explore Interfaces, at which Change Management and LCM will be taken up for explanation. Other important aspects relating to the subject of combination products, namely compliant safety reporting for combination products and documentation requirements and interfacing, will be described in detail at this session.

Over the two days of intense learning, Salma will cover the following areas:

Documentation requirements and interfacing

Regulations in the US and EU Dealing with Combination Products 4

  • Documentation requirements for combination products EU
  • Documentation requirements for combination products US
  • Interfacing, development, quality, regulatory
  • Managing third parties and document control.

This seminar is of high value to professionals whose work is related in one or another way to combination products, such as Regulatory Affairs, Medical Officers, and Clinical Trial Managers.

click to continue reading

 

 

GMP and Regulatory Expectations for Early IND Products

 GMP and Regulatory Expectations for Early IND ProductsWhat the FDA’s recent guidance documents covering GMP requirements for Phase I products have done is to significantly reduce a few of the complexities that early phase products are typically against. These guidance documents are in addition to those that cover the CMC sections for IND submissions at Phase I.

These new guidelines appear to remove the need to follow GMPs for Phase I products; yet, this need persists in the Food, Drug, and Cosmetic Act. So, what can be said is that the need for GMP requirements for Phase I products has only been altered, not done away with. The nature of the investigational drug and the extent of the study that is planned will now determine the nature and extent of GMP-related activities.

A training session that will give complete understanding of these aspects

Steven S. Kuwahara, Founder and Principal, GXP BioTechnology LLC, will offer complete clarity on all these points of GMP and regulatory expectations for early IND products at a two-day seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance. Please visit GMP and Regulatory Expectations for Early IND Products to enroll for this seminar.

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

Advice on the GMP guidance document

GMP and Regulatory Expectations for Early IND Products3

At this seminar, Dr. Kuwahara will review the GMP guidance document and discuss how it may be integrated with the recommendations of the guidance documents on CMC requirements. It will be a one-source course at which the regulations and guidelines that apply to early phase products will be presented. In a few 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. Dr. Kuwahara will present these items in the order of product development starting from the point of R & D activities and culminating in the completion of Phase 2 clinical trials.

GMP and Regulatory Expectations for Early IND Products1

Any pharmaceutical personnel who must deal with products both in early and later phases of development, will find this presentation highly valuable, 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. Directors, Managers and Supervisors in Regulatory Affairs, Quality Assurance and Quality Control will get a grasp of these aspects.

Over these two days, Dr. Kuwahara will cover the following areas:

  • Very Early Stages
  • GLP requirements
  • Early Pre-IND Studies
  • Meetings and Preparing for the IND
  • GMPs for Phase 1 IND products
  • Requirements for Phase 2 INDs
  • Preparing for IND Meetings.

 

To continue GMP updates

Drug dissolution testing and establishing plasma drug levels in humans

Drug dissolution testing and establishing plasma drug levels in humans5

Dissolution testing is a very important tool that determines and help understand the performance and effectiveness of oral solid dosage forms. It is significant for the field of medicine because if a drug has to be effective, it must be released first from the product form, and it should then be allowed to get dissolved in the gastrointestinal fluids. This is the first step that leads to the next important phase, that of the dosage’s absorption into the bloodstream. This points to the fact that dissolution from the dosage form is a major determinant of the rate and extent to which the drug gets absorbed by the body.

Drug dissolution testing is very important during the development of drugs and drug formulations. It helps to determine if the right concentration of the drug reaches the desired or expected locus of action. This makes the investigation of the factors which affect drug absorption into the human blood flow when a drug product is taken orally important.

The usual method of measurement of drug absorption is in vivo, or, the body of a living being such as a human or animal. Time blood plasma concentration profiles of drugs after oral administration constitute an important in vivo parameter. In-vitro investigations are carried out for identifying the parameters involved in drug absorption. These are investigations that are conducted in a controlled and simulated environment that resembles biological conditions closely.

Thorough learning of drug dissolution

Drug dissolution testing and establishing plasma drug levels in humans

An important seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will offer valuable learning on all the aspects of drug dissolution testing and explain the ways of establishing plasma drug levels in humans.

At this two-day seminar, Dr. Saeed Qureshi, who has worked as a research scientist with Health Canada and is an internationally known expert on the subject whose expertise spans the areas of drug dissolution testing, pharmacokinetics, biopharmaceutics and analytical chemistry as related to animal and human studies for developing and evaluating pharmaceutical products; will be the Director.

In order to gain the benefit of learning from this world-renowned expert, please enroll for this seminar by visiting Drug dissolution testing and establishing plasma drug levels in humans. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

All aspects of drug dissolution and establishing plasma drug levels

Drug dissolution testing and establishing plasma drug levels in humans1

This seminar will provide its participants a unique opportunity to learn scientifically valid drug dissolution testing and establishing plasma drug levels. Lab personnel take several approaches to conduct dissolution testing using different apparatuses and methods. This makes section of an appropriate apparatus and method confusing and challenging. Dr. Qureshi will offer relevant pharmacokinetics and physiological background that is aimed at making this choice easier and intuitive. He will use simple and clear language in helping participants understand how to select or develop a dissolution method. He will describe the theoretical aspect of the drug dissolution testing, including method development, in detail. He will explain the pros and cons of different approaches.

Another important area that Dr. Qureshi will address is in vitro-in vivo correlation (IVIVC). He will address the particular issue of the use of the concepts of convolution/deconvolution and IVIVC in providing an estimate/prediction of expected drug levels in humans through drug dissolution testing. This approach has met with limited success. Dr. Qureshi will explain the reasons for this and suggest alternative approaches and will offer an explanation of the underlying scientific principles involved in convolution, deconvolution and IVIVC techniques with simple practical examples. He will describe a unique and simple approach based on convolution technique using spreadsheet software.

He will show in vitro drug dissolution testing and convolution/deconvolution techniques for predicting plasma drug levels using the principles of pharmacokinetics and physiology. Dr. Qureshi will cover the following main areas at this seminar, with its relevant subtopics:

Personnel who work in various levels of the areas of Pharmaceutical Development, setting up analytical methods (pharmacopeial, regulatory or in-house developed), R & D (both analytical and formulation), Project Management, Quality Control, Quality Assurance, and Regulatory Affairs will benefit enormously from this learning.

To join us for more information, get in touch

 

Regulatory Filing Requirements and Compliance Processes for medical devices in Japan

Regulatory Filing Requirements and Compliance Processes for medical devices in Japan.jpg

The market for medical devices in Japan is pretty huge. It ranks third in the world after the US and the EU. At just over $ 35 billion a year, which is characterized by an annual growth rate of 3-4 percent; it is far bigger than the markets in the neighborhood, such as China, Malaysia, Singapore and even Australia. Its market for medical devices is comparable to those of Europe and North America. Some of the reasons for this huge market are:

  • The aging population
  • The huge spending power of one of the world’s largest economies
  • The infusion of new technologies into the field of medical devices, which pushes up costs initially
  • The high proportion -nearly a quarter of the entire market -of imported medical devices, especially from the US, which introduce sophisticated, technology-driven products of higher price into the market

Japan’s classification system of medical devices, which classifies these products into Class I, Class II, Class III and Class IV; varies from that of the US or the EU. Adherence to Japanese Industrial Standards, which define industry-wide safety and performance requirements, is mandatory for medical devices.

In addition, the Japanese medical devices market has been undergoing a few major changes. Medical device manufacturers have to deal with strict new package insert requirements. The Marketing Authorization Holder (MAH) system, which deals with licensing rules, have changed, requiring a new MAH License category for In Vitro Diagnostic (IVD) devices. New changes have been made into several other aspects of medical devices. These include:

Medical device manufacturers have to also reckon with expanded scope of third party certifications, and comply with rules for Software as a Medical Device and for transferring pre-market certifications.

Full explanation of the regulatory requirements 

Regulatory Filing Requirements and Compliance Processes for medical devices in Japan1

All these factors make it very important for medical devices that want to enter the Japanese market, to get a thorough understanding of the regulatory requirements. Complete understanding of all these and more will be imparted at a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance.

David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry; will be the Director of this seminar. David carries an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance arenas.

 

Please log on to Regulatory Filing Requirements and Compliance Processes for medical devices in Japan to enroll for this highly valuable training session which will put the whole gamut of regulatory requirements for medical devices in Japan in perspective. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

 

Understanding how to streamline the regulatory process

Regulatory Filing Requirements and Compliance Processes for medical devices in Japan3

By attending this seminar, participants will be able to get a proper grasp of the entire registration and approval process in Japan. They will be able to identify and understand the major changes to medical device registration process in Japan. This will help them to streamline the medical device registration process, which will help them to obtain approval for their product in the most cost-effective and timely manner.

 

At this highly interactive session, the Director will let participants discuss their own device registration and approval process relative to their work-related responsibilities and handling submissions. This will be a very hands-on approach to helping them to review and discuss pain points, challenges and solutions.

David will cover the following areas at this seminar:

  • Which regulatory bodies in the Japanese government are responsible for medical device registration in Japan?
  • In Japan, are medical devices required to be registered before they can be sold?
  • What are the different regulatory classifications for medical devices?
  • What are the different application categories for medical device registration?
  • What does the registration pathway look like for each regulatory classification?
  • What are the document requirements for notification for the various classes of medical devices?
  • What are other requirements that are necessary for approval in addition to the device application?
  • Is local testing (type testing/sample testing) required for registration?
  • When are clinical studies required for registration?
  • Is approval in the Country of Origin required for registration?

 

To join us for more information, get in touch

 

 

 

Top Healthcare Webinars You Can Get for $10

The cost of learning a new skill in regulatory compliance1Used to paying over $250 for a high quality healthcare webinar from a leading expert on the topic from a reputable provider of professional trainings? Let us change your habit! You no longer have to pay this much. So, how much do you think you need to be paying for top healthcare webinars? $200? $150? $100? None of these. All that you have to pay for a top healthcare webinar is $10!

Yes, no spelling errors here. It is indeed $10. That is all you need to pay for a healthcare webinar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance. There is a whole list of top healthcare webinars you can get for $10. There are just so many on offer; you will be spoilt for choice:

Healthcare reform is one of the hot areas of healthcare today, what with many regulations that keep coming up from time to time about this critical sector of the economy. This top healthcare webinar you can get for $10 equips you with many facets of the Affordable Care Act, or what we have come to call Obamacare. What impact will it have on employees and employers? Find out through this webinar.

Healthcare is an area in which FMEA applies very strongly. When something goes wrong at the healthcare provider’s location; it throws the whole system out of gear. Carrying out a thorough failure mode and effects analysis is a great antidote to these problems. Want to find out how to do it? This top healthcare webinar you can get for $10 has the answers.

But one question has not been answered yet: Why is GlobalCompliancePanel doing this? Why is it having this offer now? Well, it is because it wants to ensure that the community of regulatory professionals grows, and grows well. Having been in the professional trainings area for ten years now; it feels this is something it needs to do in order to draw more people into the regulatory trainings network. By offering top healthcare webinars you can get for $10; GlobalCompliancePanel wants to contribute its mite to enhancing and expanding the learning community.

Isn’t this offer of top healthcare webinars you can get for $10 the ideal means to growing up in your career? After all, we spend this amount on myriad things that could be of some use to us, but does this use compare with the enormity of the utility a healthcare webinar gives? These top healthcare webinars you can get for $10 each help you climb your professional ladder. This in turn could help your organization make a name as a responsible and ethical provider of quality products. It could earn it a reputation in the market. When you can accomplish all these through top healthcare webinars you can get for $10, what are you waiting for?

Contact Details:

https://www.globalcompliancepanel.com/webinars_home?wordpress-seo-gcp-webinar-offer-2017

John.robinson@globalcompliancepanel.com

Support@globalcompliancepanel.com

+1-800-447-9407

Don’t miss out! Offer @ $10 – Online Professional Courses

7This is a great deal. What else does one call this offer $10 deal to enhance professional skill from GlobalCompliancePanel? Wait. We are talking about $10, but did we tell you what you get for $10? Did you think it is the cost of registration for the event? Well, be prepared to get proven wrong –for the happiest of reasons. $10 is the price of a single recorded webinar that GlobalCompliancePanel is putting up at this great deal @$10 to enhance professional skills with GlobalCompliancePanel!

4Yes indeed, after all the rubbing of your eyes to confirm the truth of this seal, GlobalCompliancePanel assures you that it indeed has a great deal @$10 to enhance professional skills with GlobalCompliancePanel! Could regulatory trainings become more inexpensive and more affordable? Nowhere else in the market does one something of such high value as professional trainings in the regulatory compliance area for this price. Of course, a lot of items are available in the market for this price. Let us talk about a few toiletries. Let us talk about a few used books. Let us talk about some children’s clothing. But professional trainings that will take your profession as a regulatory compliance professional a few notches higher, at $10? Well, you can take your time to believe this, but it is true.

8This great deal @$10 to enhance professional skills with GlobalCompliancePanel is open to all professionals who want to enhance their skill and learning of the regulations in their respective domains of specialization. Who wouldn’t want to, at this price? When professional trainings in regulatory compliance becomes available at this great deal @$10 to enhance professional skills with GlobalCompliancePanel; what could be a better means to spend your ten dollars!

4What is the motive behind this offer? Simple: GlobalCompliancePanel has been a provider of professional trainings for the regulatory compliance arena for a good ten years now. It has become an established name in this area. It thought, why not make our trainings more wide-ranging and accessible to many more professionals? After all, regulations do keep changing every now and then. Shouldn’t regulatory professionals keep pace with them?

3A rich assortment of courses is available at this great deal @$10 to enhance professional skills with GlobalCompliancePanel. You can choose from trainings that help you with nuances of how to establish a reduce testing program for pharmaceutical and medical device components, where the guru of starting up, developing, implementing, managing, and remediating pharmaceutical and medical device Quality Systems, Howard Cooper, will show how to derive the benefits of systematic reduced testing program include increased compliance, smaller inventory cycles, less testing, less handling, and increased productivity and efficiency.

9Are you at odds when it comes to designing, planning and conducting effective audits? Then, why don’t you purchase this webinar that comes as part of great deal @$10 to enhance professional skills with GlobalCompliancePanel, in which Mark Roberts, Head of Roberts Consulting and Engineering (RCE), a consulting firm specializing in quality system and sterility assurance compliance, will offer his insights?

There could be no better means to improve your knowledge of regulatory requirements. And the time is now, with this great deal @$10 to enhance professional skills with GlobalCompliancePanel!

Contact Details:

https://www.globalcompliancepanel.com/webinars_home?wordpress-2017-SEO

John.robinson@globalcompliancepanel.com

Support@globalcompliancepanel.com

+1-800-447-9407

 

Learn any professional courses for $10 only

GCP Offer 4

Want to enhance your regulatory compliance career by learning a new course? All that it costs is $10. Yes, GlobalCompliancePanel, a provider of professional trainings, is offering hundreds of high value regulatory compliance courses for a mere $10 each.

GCP offer 7

Regulatory compliance learning, that vital ingredient needed for professionals in any area of regulatory compliance, is a put off, because many professionals consider it expensive. But not anymore. GlobalCompliancePanel makes it possible to scale up in one’s career. What used to cost $265 is now available for $ 10, at about the price of a T-shirt. See the math: It is a saving of about 95%.

Myriad number of courses

GCp offer 9

Regulatory compliance, as we all know, is a really vast area of knowledge. With the FDA framing innumerable laws and regulations on every area that it regulates, it is imperative for regulatory professional to show compliance with the regulations. They are doomed if they fail. GlobalCompliancePanel brings hundreds of courses in all the areas of regulatory compliance to help professionals understand how to meet these stringent standards.

GCp offer 10

Want to explore what expectations the FDA has of the drug development process? Want to understand the nitty gritty of drug development and how to meet the FDA’s stringent requirements as far as IND and NDA requirements, or nonclinical or the human clinical studies required for it? Then, take a look at how GlobalCompliancePanel can help you achieve this, for just $10.

Are you working in an industry in which you are required to carry out Root Cause Analysis, but are having problems with it? Understand the fundamentals of Root Cause Analysis and get to know how to determine what caused the problem, why it happened, and what to do about it to reduce its likeliness of occurrence, with this course from GlobalCompliancePanel.

GCP offer 8

Have you understood how to get HACCP validation done for your facility? Do you have a problem in grasping its validation and verification? No worry. This recorded webinar from GlobalCompliancePanel will set you on the path to it. At just $10, it will offer you the knowledge you need for understanding how to tackle supplier and other issues and put in place a robust HACCP validation and verification program.

This is just a small sample of the many courses that are on offer for $10 each. Want to explore how many more courses are on offer at this huge discount price? Then, just visit our website to open up the possibility of unlimited learning. All that you need to spend is just $10 to enhance your learning on an area of regulatory compliance.

GCp offer 11

Contact US:

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com

support@globalcompliancepanel.com

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

Website: http://www.globalcompliancepanel.com

Registration Link –

https://www.globalcompliancepanel.com/webinars_home?wordpress-seo-gcp-webinar-offer-2017

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel