Ensuring compliance with drug advertising promotional claims requirements

Advertising is a highly challenging and creative field. However, when making claims about the efficacy and effectiveness of products, especially drug products, advertising professionals need to comply with strict compliance guidelines which set out the limits of claims. The US government lays considerable stress on the veracity aspects of the advertising claims.

An ad for a drug product must state not just the benefits of a product, but also its side effects, risk and a lot other information such as the product ingredients, generic name/s, and proper indications of use. In addition, the image of models shown for the product should be inappropriate.

It should represent the correct age group for which the product is prescribed, and should not show a model of any other age group in the ad. If a cough preparation is targeted at the teenage population, the ad image should show only a teenager as a model and not someone who is older or younger.

The FDA has many requirements on the validity of advertising claims

In addition, there is another very important requirement from the FDA: The print ad should ask the user to report a negative finding to MedWatch and should give the contact numbers of the agency to whom to report negative findings of the use of the drug. The ad promotion branding should also advice the user to seek medical opinion before using the drug, so that expert medical advice is taken and the patient does not take the drug at will.

Offering clarity on the gray areas of advertising and promotional material

These said, there is considerable confusion about the subjective, or what are called gray areas of advertising claims. The issue is how to interpret these gray areas of a product or the ad, which will make a difference to the user’s decision making.

A webinar that is being organized by Compliance4All, a leading provider of professional trainings for the areas of regulatory compliance, will seek to clarify on these and other related areas of drug ad promotion.

Peggy Berry, who is the President and CEO at Synergy Consulting, where she provides consulting services to companies in all aspects of drug development, will be the speaker at this webinar. Over the course of this 90-minute session, Peggy will explain the requirements for compliance within the US. To benefit from the enormous experience Peggy brings into field, please register for this webinar by visiting

http://www.compliance4all.com/control/w_product/~product_id=501227LIVE?Wordpress-SEO

A description of all the issues relating to advertising and promotional material

She will explain the gray areas that must be evaluated thoroughly. She will show the ways of conducting a risk assessment and suggest and describe the strategies for mitigating risks and making challenging decision. She will familiarize participants with the critical situations and the important kinds of promotional materials in which advertisers could potentially get inputs and suggestions from regulatory agencies. She will equip participants with the knowledge needed for handling these situations. An understanding will be given of the important promotional materials and the strategies for implementing review processes and procedures to facilitate high compliance standards.

An important leaning offered at this webinar is compliance issues in the creation of advertising and promotional materials. Peggy will explain what needs to be done internally to assure assessment, evaluation and documentation of the advertising material.  Attending this webinar will ensure that the participants put in place an advertisement claims compliance program that will ensure full understanding and communication of potential risks associated with materials. The webinar will also give them the ability to mitigate risk through small but important amendments, which will go a long way in ensuring a high level of compliance standards by all the staff concerned.

Peggy will cover the following areas at this webinar:

o  Compliance Requirements

o  Submission Requirements

o  Prior to Approval

o  Direct to Consumer

o  Social Media

o  Medical Affairs

o  Sales Training

o  Review Process Considerations.

https://www.fda.gov/drugs/resourcesforyou/consumers/prescriptiondrugadvertising/ucm082284.htm

https://www.fda.gov/drugs/GuidanceComplianceRegulatoryInformation/guidances/ucm064956.htm

Writing error-free procedures while complying with GMP regulations

In the area of GMP regulations, procedures are very vital, for both execution and audits. It is always true that the greater the clarity and comprehensiveness with which these procedures are written; the easier it becomes for users to use them without missing important information for regulators.

Despite the advent of technology into almost all the areas of GMP regulations; there is still the existence of the human factor. It is still the major culprit when it comes to losses that many industries sustain in their quality and production. Technology has pervaded most industries in ways that were not imaginable a couple of decades back; yet, it is not likely that human error will ever be totally eliminated.

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Having said this, it is also true that it is possible to prevent several human performance problems. The starting point of human errors start is the design stage. Human reliability comes into play in a major way in procedures. The key to human engineering, improving and/or fixing and identifying exactly where the weaknesses in the procedures instructions lie is getting a grasp of human behavior and the psychology of error.

A learning session on all the aspects of writing for GMP regulations

An understanding of the weakness in procedures that harm productivity, quality and regulatory standing will be the major learning a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering.

The speaker at this webinar is Ginette Collazo, a human error and human behavior expert, who brings vast experience in the technical training, organizational development and human reliability areas. Interested in gaining insights into how to understand and reduce human errors in GMP procedures? Then, all that you need to do is to register for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501285LIVE?Linkedin-SEO

Discussion of all the areas of human error in writing for GMP regulations

At this webinar, Ginette will discuss everything from content development to formats designed for human error reduction due to procedures. She will start with an outline of SOP writing and describe the role and possibility of human error in content development. She will also discuss the universal purpose of procedures in the background of regulatory compliance.

Ginette will expound the human perspective and the rational for procedure use and describe human error as a root cause. She will also explain the thinking and reading process and touch upon some common mistakes and causes.

Human error rates and measurement, the ways of creating and maintaining a procedure, as well as the goals of a procedure, will all be taken up.

Taking a glimpse at Good Procedure Writing practices

Another of the areas Ginette will traverse during the course of this very interesting session is Good Procedure Writing practices, during which she will dwell upon all its related aspects such as Terminology, Formats, layouts, mixed cases, steps content, common words, references, branching, conditional steps, the use of “Precautions”, “Warnings” and “Cautions”.

Finally, she will also explain procedure styles and the use of electronic information networks for procedure access. All in all, this promises to be a very educative and well-rounded teaching session. All the important people involved in GMP regulation and human factors, such as QA/QC Directors and Managers, Process improvement/excellence Professionals, Training Directors and Managers, those in Plant Engineering, Compliance Officers, Regulatory Professionals, people in Executive Management, Manufacturing operations Directors and Human factors Professionals, will all derive benefits in large measure from this webinar.

What to expect during GMP Inspection

Regulatory agencies such as the FDA conduct inspections for product-related Good Manufacturing Practice (GMP) in the course of assessing an application for marketing approval. The basic purpose of product-related GMP inspections is to check for compliance with the GMP guidelines set out in the International Conference on Harmonization (ICH) and national and local GMP regulations. GMP is the slightest standard that a manufacturer has to mandatorily meet in its production processes. The aim of implementing GMP is to ensure that products

o  Are of consistently high quality

o  Are appropriate to their intended use, and

o  Meet the requirements of the marketing application or product specification.

Many factors trigger a product-related GMP inspection

The reasons for which these product-related GMP inspections can be triggered are quite similar to those that trigger an OSHA inspection. It can be due to any of these:

o  A whistleblower

o  In the course of inspecting other products in the facility

o  By regulatory agencies other than the one that is meant to carry out the inspection

o  When the regulatory agency comes to know of or suspects a breach.

Thorough preparation is the key to success at a product-related GMP inspection

There are several aspects to a product-related GMP inspection that needs to be borne in mind. They could happen simultaneously, or they may happen after an announcement to this effect.

Given the complexity of the nature of a product-related GMP inspection; it is essential to understand the intricacies of this exercise. A failure at a product-related GMP inspection is sure the cost the organization a lot in terms of money and effort.

It is because of the critical importance of success at a product-related GMP inspection that an organization needs to be thorough in its preparation for such an inspection. Organizations that go through product-related GMP inspections need to be ready for a product-related GMP inspection from a number of important perspectives.

Training on how to prepare for a product-related GMP inspection

This is the training a webinar from Compliance4All, a very well-known provider of professional trainings in all the areas of regulatory compliance, will be offering.

The speaker at this webinar is Peggy J. Berry, the President and CEO at Synergy Consulting, where she provides consulting services to companies in all aspects of drug development. Understanding how to be prepared for a product-related GMP inspection from Peggy is easy. All that is needed is to visit http://www.compliance4all.com/control/w_product/~product_id=501225LIVE?Linkedin-SEO to enroll.

The aim of this webinar from Compliance4All is to offer practical tips and advice for ensuring that all inspections are conducted in the most effective and efficient way possible. The core components of ensuring these include:

o  Ongoing readiness for inspections

o  Rehearsals and preparation for successful facility inspections, and

o  Knowing how to respond to findings by regulatory agencies.

Peggy will offer in-depth insights into these aspects of product-related GMP inspection.

Handling inspections can be a tough job

Regulatory agency inspections are not the easiest of people to handle and manage during a product-related GMP inspection. They can be very fussy and tough. Organizations that have no idea about how to manage product-related GMP inspections can have a difficult time with these inspectors, no matter from various regulatory agencies they hail.

At this webinar, Peggy will show what to expect during the product-related GMP inspection. She will also show the ways of successfully and efficiently streamlining and managing the inspection. She will also highlight the importance of adequate follow-up during and after the inspection.

During the course of this 90-minute session, which will be of tremendous use to professionals related to GMP, such as Design Engineers, and those in manufacturing, supply chain, technical operations, Quality Control, Quality Assurance and Regulatory Affairs, Peggy will cover the following areas:

o  Types of Inspections (for cause, pre-approval, periodic ) > API & FDF

o  Notification Timing

o  Foreign Facilities

o  What to expect during Inspection

o  Do a company audit as the FDA would (fall dress rehearsal)

o  Make adjustments as needed/address issues/take needed actions

o  Managing the Inspection

o  Inspection on follow-up.

Works Quickly Meeting the FDA’s Quality and compliance requirements

Quality and compliance are vital issues for any medical devices company. Despite the fact that the FDA’s regulatory compliance requirements are the same across the industry; many medical device companies are shocked when they receive a 483, or a Warning Letter, or even a consent decree. Is meeting the FDA’s regulatory requirements something of a chance, which some organizations get by fluke and others don’t?

This is simply not the case. Quality and compliance are built into a medical device product. It is only that companies need to have the capabilities needed for meeting Quality and compliance requirements from a regulatory perspective. If medical device companies have to be successful in their endeavors in the future, they have to be adept at how to meet quality and compliance requirements set out by the FDA.

Quality and compliance to meet regulatory requirements

Why is this needed? Simple: If medical device companies do not meet regulatory requirements set out by the FDA; they are not likely to meet the quality requirements demanded of their products. As a result, apart from being unable to create products that appeal to customers, they could end up facing punitive actions from the FDA.

As said, meeting Quality and regulatory compliance requirements is not something of a gamble. Quality and compliance, which are the key inputs for meeting customer demands, can be fulfilled by putting a thorough process in place. These are capabilities a medical device company needs to have if it has to meet quality and compliance requirements and succeed in the market.

Learn the ways of meeting Quality and regulatory requirements from the expert

The method by which medical device companies can achieve regulatory compliance requirements and ward off punitive actions from the FDA will be taught at a very interesting and lively webinar from Compliance4All.

The speaker of this webinar, Susanne Manz, an accomplished leader in the medical device industry, who emphasizes Quality, compliance, and Six Sigma and brings extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities, will demonstrate just what medical device companies need to do in order to meet Quality and regulatory compliance.

To gain complete insights into how medical device companies can take the requisite steps needed for meeting quality and compliance requirements, please enroll for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501160?Wordpress-SEO

An explanation of the seven capabilities needed for meeting quality and compliance requirements

At this session, Susanne Manz will explain that there are seven capabilities that are needed for medical device companies to accomplish their aim of meeting Quality and regulatory compliance requirements. She will explain these and offer complete understanding of how the changing regulatory climate needs to be comprehended. She will show how to evaluate one’s capabilities to develop a regulatory strategy that will help companies meet their requirements, so that they become successful in the pursuit of their objectives.

Susanne will show how to develop strategy from one’s self-awareness of the Quality and regulatory requirements. At this webinar, she will cover the following areas:

o  Evolving Regulatory Climate

o  Seven Key Capabilities for Success

o  How to evaluate and map your capabilities

o  Quality Planning and Improvement

o  Maturity Modeling

o  Developing Your Quality and Compliance Strategy.

Demonstrating Product Reliability

Product Reliability is among the most important attributes for a product, no matter what kind of product one is considering. Product Reliability can be defined as the likeliness or probability of the product performing its stated purpose, in the light of the conditions under which it is going to be put, for a defined period of time.

The parameters used for quantification of Product Reliability are:

o  MTBF or Mean Time Between Failures for products that can be repaired and used, and

o  MTTF or (Mean Time To Failure) for products that cannot be repaired.

If these are the parameters used for quantifying Product Reliability, how does one predict it? Quality professionals use a relatable analogy to explain how to assure measurability of Product Reliability. This is known as the bathtub curve analogy, where the start or early life of the product is placed at the start of the bathtub. As the product starts getting used, it moves on to the phase of its useful life, from where it moves on to its wear out time.

The time taken for each of these processes is the indication of Product Reliability. Product reliability using the bathtub curve analogy suggests that at the beginning of the product lifecycle, the probability of failure rate is relatively less. As the product progresses on to its next phases, the probability of failure rate increases. This is the root of the understanding of predicting Product Reliability. Mathematical formulae are used to describe these.

How does on get Product Reliability right?

The ways of choosing the right reliability parameters for failure rates of respective products and estimating their lifecycle in the light of failure rates will be the topic of a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

At this webinar, Steven Wachs, Principal Statistician at Integral Concepts, Inc. where he assists manufacturers in the application of statistical methods to reduce variation and improve quality and productivity, will be the speaker. To benefit from the experience Steven brings into Quality, please register for this webinar by logging on to

 

http://www.compliance4all.com/control/w_product/~product_id=501164?wordpress-SEO

A description of the various approaches to Product Reliability

Steven will offer and explain several approaches that can be used to verify whether reliability targets or specifications have been achieved at the desired level of confidence. In particular, he will describe the approaches using time-to-failure data to estimate reliability metrics.

Also taken up at this session, which will be of immense use to anyone with a vested interest in product quality and reliability, such as Product Engineers, Reliability Engineers, Design Engineers, Quality Engineers, Quality Assurance Managers, Project/Program Managers, and Manufacturing Personnel are demonstration tests, where minimum reliability may be demonstrated with zero or few failures.

A description of the methods that increase the risk of failures

Steven will discuss the kind of methods, which when used, increase the risks of field failures due either to inadequate designs or misconstruction of product use conditions that need to be managed. He will also offer the options for verifying and demonstrating that customer reliability requirements have been achieved.

Steven will cover the following areas at this webinar:

o  Overview of Reliability

o  Reliability Metrics and Specifications

o  Estimating Reliability with Time-to-Failure Data

o  Confidence Intervals and Bounds

o  Demonstrating Reliability with zero or few failures

o  Tradeoffs between Testing Time and Sample Size

o  Impact of Assumptions on Test Plans

o  Improving Demonstration Test Power

http://ftp.automationdirect.com/pub/Product%20Reliability%20and%20MTBF.pdf

Implementing cGMP quality systems and risk management approaches

After carrying out the initial preclinical studies, drug manufacturers need to implement cGMP quality systems and risk management approaches during commercial development and operations in order to be able to meet the requirements of the FDA’s current Good Manufacturing Practice (cGMP), which are contained in and are governed by regulations 21 CFR parts 210 and 211.

The FDA’s guidance on cGMP quality systems and risk management approaches is meant to help drug manufacturers implement the most current and acceptable cGMP quality systems and risk management approaches so that they meet the requirements set out in the FDA’s cGMP regulations, namely 21 CFR parts 210 and 211.

The FDA’s guidance on cGMP quality systems and risk management approaches describes an all-encompassing Quality Systems (QS) model and explains and highlights the way and extent to which the Quality model has to be consistent with the CGMP regulatory requirements for manufacturing drugs in the human, veterinary and biological categories.

FDA guidance on cGMP quality systems and risk management approaches is not mandatory

The FDA guidance on cGMP quality systems and risk management approaches also offers help to manufacturers who need to implement the Quality Systems in being in complete compliance with CFR Parts 210 and 211. However, these guidances on cGMP quality systems and risk management approaches are not obligatory or mandatory for drug manufacturers. They are not legally enforceable. Rather, like all other guidances, they are suggestive in nature and reflect the FDA’s thinking on a particular topic at a particular point of time. Although the FDA uses the word “should”, it only means something that is of a recommendatory nature.

Full compliance is expected

Even though the FDA’s cGMP quality systems and risk management approaches is not legally enforceable; that the FDA expects full compliance with its requirements is a given. Drug companies that fail to show complete compliance with the cGMP quality systems and risk management approaches are penalized. Such companies end up paying huge fines and face all sorts of issues and problems. So, it is in their best interest to show compliance with the FDA’s cGMP quality systems and risk management approaches.

A learning session on FDA guidance on cGMP quality systems and risk management approaches

The ways of implementing cGMP quality systems and risk management approaches will be the training a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering. The speaker at this session is the highly acclaimed and experienced professional, Jerry Dalfors, who has for over four decades been helping drug companies in a business administration, consultative, technical and managerial role in the development and manufacture of highly regulated biopharmaceutical products.

This session on implementing cGMP quality systems and risk management approaches will guide participants on what they can do to minimize patient risk and increase ROI. The speaker will show how this is a better option compared to paying outside contractors to fix errors.

Understanding FDA guidance on cGMP quality systems and risk management approaches from two important perspectives

This learning is important from two perspectives. First, it will help participating companies learn the nitty-gritty of implementing cGMP quality systems and risk management approaches.

Second, Jerry will help a drug company that is in the business of manufacturing materials that are regulated by the respective country’s government to ensure that the design and established operations are going meet both the local regulations but also those of the places to which the product might be shipped.

Jerry will cover the following areas at this session:

CGMPs and the concepts of current quality systems, including quality by design and development, risk management, CAPA, Change Control, Management Responsibilities, Resources, Manufacturing and Evaluation Activities.

o  Terms and Definitions – with related acronyms

o  Quality Management System – Quality = Profitability and does all it can to minimize operator errors

o  Documentation Requirements – entering data, comments and making corrections

o  Management Responsibility and GMP/Quality Commitment

o  Quality Policy – General elements of the Quality Manual and Individual Training Requirements for each job description.

o  Human Resources – Individual employee files providing documented evidence of required education or experience and related training for the individual’s position

o  Purchasing, Incoming Control and Raw Material Release

o  Gowning, Environmental Control and Monitoring

o  Product Testing, Inspection and Document Review for Final Product Release

o  Incident Tracking, Change Control, CAPA and Annual Quality Review

http://www.compliance4all.com/control/w_product/~product_id=501172LIVE?Wordpress-SEO

http://www.fda.gov/downloads/Drugs/…/Guidances/UCM070337.pdf

Expect drastic changes to the in-vitro diagnostics market in the upcoming years

The in-vitro diagnostics (IVD) market is a diverse and fast changing one. Of late, one of the significant changes that happened to it resulted from the passage of the Final Rule. As part of the Affordable Care Act (ACA) or Obamacare, the Centers for Medicare and Medicaid Services (CMS) introduced the Final Rule to the 2014 Protecting Access to Medicare Act (PAMA) in mid-2016, which is set to make a significant impact on the in-vitro diagnostics market by delaying implementation of market-based pricing reform for Medicare-reimbursed lab tests.

It also increases the range of applicable labs so that the prices become realistic and reflect that of the entire lab market. This change to the ACA thus can considerably scale down Medicare reimbursement prices on sophisticated, high technology tests that are routinely required. The trickledown effect of this Final Rule thus is that it is expected to consolidate the clinical lab services market, making it imperative for the in-vitro diagnostics market to develop elements such as biomarkers and assays routine.

And now, the new regime…

These expected changes have to reckon with the possibility of the whole system of affordable healthcare, the soul of Obamacare, undergoing changes with the inauguration of the new US President, Donald Trump, in early 2017. In line with his strong electioneering emphasis on repudiating the whole idea of affordable healthcare, among the first executive orders that he signed barely days into his presidency, he strongly exhorted his party to dismantle the plan. This is being seen in the administrative and healthcare circles as a sure first step towards its replacement.

Although the final annulment of Obamacare, if it does indeed come about, will take months and perhaps even years to materialize, it is something that can be expected of the new administration. All this has brought about a new phase of uncertainly about the very existence of Affordable Care Act, whose impact on the in-vitro diagnostics market was beginning to just get felt, as we saw.

Plus, regular factors that affect the IVD market

While all these are the crucial factors that can bring about changes to the in-vitro diagnostics market and make a difference to the industry; there is also the set of regular scenarios that need to be taken into consideration by those who design, code, manufacture, sell, buy, use or order in-vitro diagnostics. It is that the FDA keeps coming up with new plans for the industry every now and then. these could make a huge impact on those in the in-vitro diagnostics business.

In what ways do changes mean in in-vitro diagnostics for professionals in the industry and how does it affect them in the pursuit of their business objectives? A webinar from Compliance4All, a leading provider of professional trainings for the areas of regulatory compliance, will seek to answer these questions.

At this webinar, Anna Longwell, who is currently principal attorney of the Palo Alto Law firm, Longwell and Associates, which specializes in Food and Drug law, will be the speaker. To register for this highly valuable learning session, please visit

http://www.compliance4all.com/control/w_product/~product_id=501131LIVE?wordpress-SEO

Anna will take up important topics related to in-vitro diagnostics, such as how a business or practice may get affected by the changes taking place in the in-vitro diagnostics area.

She will follow it up with a review of the FDA’s draft plans for Medical Device User Fee and Modernization Act (MDUFMA), the Laboratory Developed Test (LDT) vs. IVD issue, the approach to globalization embodied in the proposed acceptance by FDA of the International Medical Device Regulators Forum (IMDRF) Software guidance, the drug and medical device development tools programs (biomarkers), Software as clinical decision assistance and Multi-Analyte tests such as DNA NGS.

This webinar will cover the following areas:

·                    Basic Definitions

o                 Label, Labeling, Advertisement

o                 Intended Use, Indications for use

·                    Off-label Use

o                 The Recent Acclarent Indictment

o                 Scientific literature and Freedom of Speech

·                    Prescription vs OTC

·                    in-vitro diagnostics a Special Case (21 CFR 809): RUO and IUO

·                    “Restricted Devices”

·                    Electronic Labeling

·                    Marketing practices Interactions with HCPs

http://www.kaloramainformation.com/Content/Blog/2016/07/07/With-Final-Rule-PAMA-Set-to-Spark-Changes-in-Lab-Market-and-in-vitro diagnostics-Strategy

https://www.nytimes.com/2017/01/21/upshot/what-does-the-order-against-the-health-law-actually-do.html?_r=0