GMP Expectations for Products Used in Early Phase IND Studies

GMP-related activities will depend upon the nature of the investigational drug and the extent of the study that is planned.


FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1.

Although the guidance appears to remove the need to follow GMPs for Phase 1 products, the need to follow GMPs is still present in the Food, Drug, and Cosmetic Act. Thus 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.

  • Discussion of the elements found in the guidance document for Phase 1 material
  • What to do at really early stages
  • What about special IND studies?
  • What about preclinical studies?
  • Varying GMP activities that depend upon the nature of the IND product
  • What are the requirements for the GMP found in the Food, Drug, and Cosmetic Act?
  • What to do about QC activities such as instrument qualification, method validation, and process validation

These guidelines remove some of the problems

Essential Components of Courses on Good [Clinical Practice] 2019

Integrity and confidentiality of the subjects that take part in a clinical trial.

Good Clinical Practices is a set of standards for the scientific and ethical aspects of the following elements of clinical trials:

–       Design

–       Conduct

–       Performance

–       Monitoring

–       Auditing

–       Recording

–       Analysis

–       Reporting.

The soul of GCP is that the adherence to its principles gives the assurance that the clinical trials are accurate, credible, verifiable and reproducible. These are the hallmarks of a scientific experiment, which means that complying with the principles enunciated in GCP makes the clinical study scientifically valid. In addition to ensuring the scientific validity of clinical trials, GCP principles also cover another critical aspect: the rights, integrity and confidentiality of the subjects that take part in a clinical trial.

For these reasons, Good Clinical Practices are considered the ISO of clinical trials. The ICH’s Harmonized Tripartite Guideline for Good Clinical Practice describes these methods. Good Clinical Practice guidelines are also issued by regulatory authorities such as the FDA, the European Medicines Agency (EMA) or The Medicines and Healthcare Regulatory Agency (MHRA) of the UK.

Essential Components of Courses on Good Clinical Practice

The career path for any clinical professional starts with gaining academic knowledge of these regulations and the practical ways of implementing that knowledge. In niche, high specialty areas such as Good Clinical Practice, which are technical in nature and not a subjective or creative area like art or writing; getting sound knowledge of the areas of GCP is essential. Also, practicality is one of the essential components of courses on Good Clinical Practices. While knowledge is imparted from books, training and experience help to put that knowledge into practice, which is essential to make the person a solid professional.

This being the nature of Good Clinical Practice, what are the essential components of courses on Good Clinical Practice? Keeping the essential components of courses on Good Clinical Practice in mind is very important for anyone who wants to take up courses on GCP, because courses on GCP are what provide the knowledge needed for becoming clinical professionals.

The need for the inculcation of professionalism and efficiency into the work of a clinical professional can perhaps be appreciated from the fact that back in 2014, in the UK alone, as many as three million people volunteered to become subjects at clinical trials. This underscores the need for proper knowledge of the subject. Courses that impart knowledge of clinical trials have to consist of a few essential components on Good Clinical Practice. Let us examine some of them:

Knowledge of regulations

Regulations sit at the very heart of GCP. Good Clinical Practice is a highly regulated area because of its highly scientific nature and for the potential it has for causing serious consequences if something goes wrong. Clinical trials can cause adverse events. An adverse event is any bad experience with a drug that can cause even death. Adverse outcomes have the chance to mar the whole trial.

It is to help counter events of such magnitude that GCP guidelines are set. Deep and insightful knowledge of the nature of the guidelines, which will help prevent adverse events is among the essential components of courses on Good Clinical Practice.

One other essential component of courses on Good Clinical Practice is that they must incorporate learning on the ISO standard which deals with clinical trials: the DS/EN 14 155 “Clinical investigation of medical devices for human subjects – Good Clinical Practice”. A course on GCP should also impart learning on the Addendum for ICH-GCP, Guideline for Good Clinical Practice E6(R2). This requirement was approved on 15 December 2016 by a committee in the EMA, namely The Committee for Medicinal Products for Human Use (CHMP). It came into official existence from June 14, 2017. These are some of the important principles that Good Clinical Practice professionals will implement during their careers. Familiarizing them with these is very essential to a course on GCP.

How to adhere to regulations

Solid Evidence That Attending Medical Devices Training Is Good for Your Career Development

These bodies also state the nature of the regulations and the requirements that medical device and healthcare organizations need to adhere to in order to meet their expectations.

Training is the foundation to producing products and services that meet regulatory and quality expectations and industrywide acceptance. This is generally true for all products and services, but in particular, for medical devices. Why? Medical devices are not in the same league as any other ordinary product that can be handled by anyone in any manner.

Training is the only means by which medical device companies that manufacture medical devices and the staff that handle these products on a daily basis and administer them on patients, can ensure patient safety. Training that imparts a degree of understanding of the methods, processes and technologies in this field is the means to this and to meeting the quality requirements.

Training ensures safety and quality in the manufacture and use of medical devices

Medical devices are highly specialized products that require extreme care and diligence when handling. A slight error or carelessness can result in far-reaching consequences that have the potential to cause anything from physical harm to death for the patient or the user. This explains the criticality of training for medical devices because an untrained person is more likely to cause errors in using these high-specialty products than a trained one.

Another core factor in medical device training is that it is part of regulatory expectations in most markets. Getting trained in the prescribed manner is very crucial for medical device professionals because training is indispensable in helping them meet regulatory requirements. The main purpose with which regulations are made is to ensure that the products that complying organizations produce and the processes they employ meet the required quality standards.

Since medical devices are an area in which one cannot take chances, regulatory agencies such as the FDA and the EMA, and standards bodies such as the ISO have made training mandatory for medical device professionals. These bodies also state the nature of the regulations and the requirements that medical device and healthcare organizations need to adhere to in order to meet their expectations.

Professionals and organizations that meet these standards are assured regulatory approval. They are also more likely to win public confidence for the quality of their products. Medical device training is what helps assure that stay updated in their professions.

Regulations mandate training in medical devices

The role of training in medical devices can be understood from the fact that it is not just another desirable, nice-to-have feature, but one that is made mandatory by regulations in this area. These are some of the regulations that make training for medical devices mandatory for companies in the medical devices field:

–       ISO 13485:2016 – Medical Device Quality Management System Requirements

–       ISO 14971

–       Medical Device Single Audit Program (MDSAP)

–       New Requirements set out by the EU Medical Device Regulation and In Vitro Diagnostics Regulations

Never Ever miss this

Facts About Compliance Courses

What is compliance? We all know the commonly used meaning of the term. One of the meanings The Oxford Online Dictionary has for compliance is its being “(t) he state or fact of according with or meeting rules or standards”. So, in the context of the regulated industries, compliance is being in a state of acquiescence or agreement with the regulatory requirements. The rules or requirements are set out by the regulatory authorities such as the US FDA or the European Union’s European Medicines Agency (EMA), or The Medicines and Healthcare Products Regulatory Agency (MHRA) of the UK, or The Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, or any other around the world.

The regulations these regulatory agencies set are aimed at ensuring compliance with standards. Of course, it goes without saying that these standards are aimed at ensuring quality and safety of drugs and other health-related products such as medical devices, food, medicines, life sciences and pharmaceutical products. It is to be in compliance with the regulations set out by these agencies that organizations that come under these regulatory bodies spend a fortune.

child Head with symbol

Why? Simple:

– Being in compliance ensures that their products are approved for release into the market, failing which all that they spend on producing the product goes down the drain;

– Lack of compliance results not only in hefty penalties and fines and other punishments which could go all the way to imprisonment; it could also result in earning a bad reputation, the quickest means to get out of business.

Compliance requirements, expectedly, are very stringent. This is very natural, considering the nature of the products that are regulated. No regulatory agency likes to take chances with the health of the people. One spurious drug in a lot of thousands could be enough to cause damage to the consumer. So, regulating these products is as onerous as ensuring the security of every individual in a nation or society.

Compliance requirements are couched in very formal and often incomprehensible language. Since the industries are highly specialized, it is impossible for the regulatory agencies to avoid jargon or legalese. It is to help understand the nuances of these regulations that organizations need the services of compliance professionals. These professionals are specialized in the particular and exact nature of these regulations and do what is required to ensure compliance.

Despite the existence of these compliance officers, many organizations could still need understanding of the regulations. This could sometimes be because of the frequency of the regulatory updates or the urgency in meeting their requirements. Or, these could be beyond the resources the organization can allocate or afford for meeting compliance requirements. Further, the nature of some regulations could be such that even experienced compliance officers may need clarity. On such occasions, organizations need the services of compliance trainings.

Continues here

Current Applications – Data Mining Medical Records [Machine Learning]

The quality of patient management such as handling patient cases or coordinating the flow of tasks, such as ordering tests, among of medical personnel.

According to data from the U.S. Department of Health and Human Services, the progress of the value-based healthcare delivery system in the U.S. — a provider payment model based on patient outcomes — has run almost parallel to the significant implementation rate of electronic health records/electronic medical records (EHR/EMR).

Market research firm Research and Markets estimates that the EHR market will reach $33 billion by 2025. The firm anticipates that government initiatives to support EHR adoption will greatly influence this trend.

As the volume of patient data increases, some healthcare professionals believe the complexity of finding tools to extract insights could grow more challenging. Researchers are exploring how artificial intelligence can help draw useful information form massive and complex medical data sets.

This article will set out to determine the answers to the following questions:

  • What types of AI applications are emerging to improve analyses of medical records?
  • How is the healthcare market implementing these AI applications?

Our research suggests that the majority of AI use cases and emerging applications for medical data mining appear to fall into three main categories:

  • Predictive Analytics: When companies and healthcare professionals use machine learning to analyze patient data in order to determine possible patient outcomes, such as the likelihood of a worsening or improving health condition, or chances of inheriting an illness in an individual’s family.
  • Diagnostic Analytics: Is defined by Gartner as “a form of advanced analytics which examines data or content” to determine why a health outcome happened.
  • Prescriptive Analytics: When research firms develop machine learning algorithms to perform comprehensive analyses of patient data to improve the quality of patient management such as handling patient cases or coordinating the flow of tasks, such as ordering tests, among of medical personnel.

Below, we present representative examples from each category, as well as the current progress (funds raised, pilot applications, etc) of each example.

Predictive Analytics

Pieces Tech

Founded in 2015, Texas-based Pieces Tech claims that it leverages AI, machine learning and natural language processing to build its software platform to interpret patient data and recommend personalized treatment approaches.

Specifically, the cloud-based software platform, Pieces™ Decision Sciences (DS), uses algorithms trained on billions of data points to draw insights from patient data, improve quality of care and to lower costs by performing analyses throughout a patient’s journey, according to Pieces Tech.

When a user logs into the online platform, they can see a sidebar with a variety of different categories, including case management, patient enrollment and last encounter. After a health provider or health professional, such as a doctor, social worker, or transporter sees a patient, they can log into the platform, click into the case management category and search for a client. They can then see a client profile where they may view information on old and recent encounters, or notes or data from one specific doctor’s appointment or interaction with the health care professional.

What Big Pharma pays your doctor

It takes at least a couple of mouse clicks to locate the material. Nor is there any more detail this year than last year about how the money is used.

Members of Innovative Medicines Canada (IMC), the lobby group for the large pharmaceutical companies, recently released their voluntary reports of payments to health-care professionals and health-care organizations.

Altogether, the 10 reporting companies paid out more than $75 million in 2017.

This is the second year of these disclosures. When they started, Russell Williams, then the IMC president, said on CBC’s The Current: “We’re open to continually improving and monitoring” the disclosures. According to the new president, Pamela Fralick, the 2016 revelations were only a first step and she expected more companies to disclose payments in 2017.

Come the 2017 disclosures, and there are still the same 10 companies. Moreover, the disclosures are actually not on the IMC website, they are on the individual companies’ websites and are not easy to find. It takes at least a couple of mouse clicks to locate the material. Nor is there any more detail this year than last year about how the money is used.

IMC touts these disclosures as “part of our commitment to high ethical standards and enhancing trust.”

But all that the companies have disclosed are gross figures — with no information about what they paid for.

Paid to promote opioids?

Why did Purdue Pharma, makers of OxyContin and a host of other opioid products, give almost $1.9 million to health-care professionals in 2017?

All Purdue’s website says is that the money was for “services.” Were some of those services speeches made by doctors on behalf of Purdue? In the past Purdue has paid doctors $2,000 a talk.

Amgen Canada gave more than $6 million to health-care organizations, but we don’t know what these organizations did with that money.

Novartis spent $350,000 on travel expenses so that doctors and possibly other professionals could go to international congresses and/or global stand-alone meetings.

Who were these health-care professionals? What meetings did they go to? Where were the meetings?

Canada lags behind

Big Pharma here in Canada is far behind the curve when it comes to disclosing where the money is going. The federal government doesn’t seem to be in any hurry to force the companies to make more information public either.

Just over a year ago, then Health Minister Jane Philpott’s position was that forcing the disclosure of payments to individual doctors was, “in principle…an important concept” but should be left to the provinces.

In the United States, companies have had to disclose any payment of more than $10 to a doctor since 2013. The doctors are named.

In Australia, an analysis of information that companies must disclose found that, from October 2011 to September 2015, 42 companies sponsored 116,845 events for health professionals.

In nine European countries, disclosure is either mandatory or voluntary. Many of the European voluntary codes allow doctors to opt out of having their names disclosed.

IMC justified not linking doctors’ names to payments on the grounds of Canadian privacy laws but Ontario’s recently passed legislation will require disclosures to include the names of all health-care professionals who receive money or any other “transfer of value.”

Later this summer, British Columbia will hold public consultations about the same type of legislation.

Point-of-care ultrasound: a reliable bedrock of the general hospital

Medical scope of practice can vary by state, country and/or local jurisdiction.

Point-of-care ultrasound is at the heart of Frimley Park Hospital’s anaesthesia department, guiding procedures such as vascular access and nerve blocks. Dr Tim Pepall, a consultant anaesthetist at Frimley Park, explained: “It’s essential to use ultrasound for central vascular access because of NICE guidelines, but we also use it occasionally for difficult peripheral vascular access and arterial lines.

Ultrasound has transformed regional anaesthetic practice and we were relatively early adopters of it – it made sense to see the nerves, rather than going in blind. There is so much variation in nerve and vascular anatomy that you realise your previous techniques were really feeling in the dark. Nowadays, I would be very reluctant to do a plexus block without an ultrasound machine.”

Tim continued: “We’ve been using FUJIFILM SonoSite point-of-care systems for the last 10 years. There are five SonoSite instruments in the anaesthetic department and we’ve stayed with the one manufacturer because we’ve been very happy with it – we like the back-up service, as well as the simplicity of the systems and the quality of images it provides.

The SonoSite S-Nerve interface is very intuitive, and it is great for portability, we can transfer it onto the wards and take it wherever we need to use ultrasound. With the new SonoSite X­Porte, we’re also doing more echocardiography than before – which saves us having to discuss preoperative cases with the cardiologists as often – and we can see dynamic changes as they occur, and responses to our interventions.”

SonoSite, the SonoSite logo, S-Nerve and X-Porte are trademarks and registered trademarks of FUJIFILM SonoSite, Inc. in various jurisdictions. FUJIFILM is a trademark and registered trademark of FUJIFILM Corporation in various jurisdictions. All other trademarks are the property of their respective owners. Copyright (c) 2018 FUJIFILM SonoSite, Inc. All rights reserved. Subject to change.

Medical scope of practice can vary by state, country and/or local jurisdiction.

FUJIFILM SonoSite, Inc., is the innovator and world leader in bedside and point-of-care ultrasound, and an industry leader in ultra high-frequency micro-ultrasound technology. Headquartered near Seattle, the company is represented by a global distribution network in over 100 countries. SonoSite’s portable, compact systems are expanding the use of ultrasound across the clinical spectrum by cost-effectively bringing high-performance ultrasound to the point of patient care.