Technical Writing for the Pharma, Device and Biotech Industries

Technical Writing for the Pharma, Device and Biotech Industries 3

Technical writing for the IT industry is quite different from technical writing for the pharma, device and biotech industries. Technical writing for the pharma, device and biotech industries is a combination of skills and science. On the one hand, it requires extensive knowledge required from these vast and diverse, albeit related industries. On the other, it requires good language skills to present on paper what would otherwise constitute dull and prosaic writing that the common reader would likely find quite obtuse.

Understand the audience

Technical Writing for the Pharma, Device and Biotech Industries

Technical writing for the pharma, device and biotech industries involves first of all, knowing whom the writing is being done for. This is the foremost requirement, because the level of jargon or depth of the subject that goes into technical writing for the pharma, device and biotech industries is directly proportionate to the level of knowledge the audience has of the subject. If the audience is a professional or academic with high credentials, it is necessary to shape the writing to suit them. Likewise, it is advisable to remain simple and effective and rid the writing of its high sounding cant if it is for a lesser audience.

Understand the minds of regulatory bodies

Technical training in the life sciences

A professional doing technical writing for the pharma, device and biotech industries needs to have a grasp of the intricacies that documentation for regulatory bodies expect and require. The FDA, Eudralex, the ISO and other such bodies require their own standards, so it is necessary for those doing technical writing for the pharma, device and biotech industries to be aware of these.

Understand for whom the writing is being done

Technical training in the life sciences1

Anyone doing technical writing for the pharma, device and biotech industries has to be aware of the market for which the writing is being done. They should understand the role and importance their writing plays with the eventual user. There should be clear understanding of whether technical writing done for the pharma, device and biotech industries is going to be used for higher research, for understanding the market better, or for understanding the competitor, and so on.

Understand the nitty gritty of the industryAlso, when doing technical writing for the pharma, device and biotech industries; the writer has to have a good grasp of the technicalities of the industries. Terms in these industries are filled with many hairsplitting definitions and specifications. The writer doing technical writing for the pharma, device and biotech industries has to be completely aware of the differences between each of these. It is only when these fundamentals among others are grasped that writing becomes successful and effective. The ability to also revise and edit what is written should be built into technical writing skills for the pharma, device and biotech industries.

 

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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

 

 

 

Psychiatric care is postcode lottery, say medical experts

Psychiatric care is postcode lottery, say medical experts

There are not enough NHS psychiatrists in some parts of the UK and more should be recruited to improve care, says the Royal College of Psychiatrists.

In Scotland, there are 10 consultant psychiatrists per 100,000 people – but only eight for the same number in England and Northern Ireland, and just six in Wales.

London’s tally is more than double that of the east of England.

English health ministers said thousands of new posts were already planned.

The government in England recently announced there would be 570 extra consultant psychiatrists by 2020-21.

And the Welsh government said it was committed to improving mental health services in Wales.

But the Royal College of Psychiatrists said there were too few medical students specialising in psychiatry and not enough psychiatrists becoming consultants.

In England, in the past five years, it said there had been a 1.7% increase in psychiatry consultants compared with a 20.2% increase in other consultants across the NHS.

Areas such as London and the north-east of England have more than 11 psychiatrists per 100,000 people but the south-west has six and Yorkshire five.

‘Falling short’

Prof Wendy Burn, President of the Royal College of Psychiatrists, said: “People with a severe mental illness should expect to see a specialist consultant, just as you would for a severe physical illness.

“The huge variation in consultant psychiatrists across the country means reality is increasingly falling short of our expectations.

“As highly skilled medics, psychiatrists must be able to spot the nuance in symptoms, ask the right questions, and understand what the problem is.

 

Read More: http://snip.ly/u70ov#http://www.bbc.com/news/health-41201396

Validation the complies with ICH guidelines

A clear and perceptive insight into how to understand and interpret statistical concepts used to investigate quantitative ICH Guidelines such as analytical methods validation, procedures, and acceptance criteria in calibration limits is required from professionals in the field of statistical analysis. They also need to have a proper understanding of process and quality controls, as well as ICH Q8 and Q9.

The guideline the ICH has set out for analytical methods validation is the ICH tripartite-harmonized ICH Guideline on Text, which was previously coded as Q2A, finalized in October 1994 under Step 4. This guideline seeks to identify the validation parameters that are required for a number of analytical methods. The characteristics and parameters that need to be taken into consideration when validating the analytical procedures that are included in the registration applications are also laid down in this guideline.

When it comes to procedures and acceptance criteria in calibration limits, the ICH guideline is the ICH tripartite-harmonized ICH Guideline on Methodology, which used to be previously coded as Q2B. This was finalized in November 1996 under Step 4. This guideline extends the ICH guideline on Text, or what is called Q2A (mentioned above) to comprise the actual experimental data required, along with the statistical interpretation, for the validation of a variety of analytical procedures.

Current Step 4 for process and Quality Control

The current guideline for process and Quality Control is the Current Step 4 version of the ICH-harmonized Tripartite Guideline. The final draft of this guideline has been recommended for adoption to the regulatory bodies of the three biggest pharmaceutical markets in the world, namely the US, the EU and Japan.

Meeting critical milestones is required for professionals who want to achieve harmonization in Quality, professionals. Conducting stability studies, the way the studies define relevant limits for the testing of impurities, and following a more malleable approach to pharmaceutical quality that is based on the principles of Good Manufacturing Practice (GMP) risk management are among these milestones. ICH’s Quality guidelines on harmonization relating to Quality cover the following areas:

o  Stability

o  Analytical Validation

o  Impurities

o  Pharmacopoeias

o  Quality of Biotechnological Products

o  Specifications

o  Good Manufacturing Practice

o  Pharmaceutical Development

o  Quality Risk Management

o  Pharmaceutical Quality System

o  Development and Manufacture of Drug Substances

o  Lifecycle Management.

A thorough training session on the areas of Validation in accordance with ICH guidelines

It is important and necessary for professionals in this area to get proper guidance, considering the complexity and the breadth of the issues associated with these techniques, which cover both the pharmaceutical and clinical applications, and considering that these techniques apply to a number of area such as stability testing, outlier analysis and risk management.

A seminar from GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will offer this learning. Dr. Alfred Bartolucci, who serves as Emeritus Professor of Biostatistics at the University of Alabama, will be the Director of this seminar. Please visit Validation the complies with ICH guidelinesto register for this valuable learning session. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A clear and deep understanding of statistical concepts

Dr. Bartolucci will offer in-depth and clear learning of the statistical concepts used for investigating quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits, and process and Quality Control, as well as with ICH Q8 and Q9.

Although not a course in statistics, this seminar will offer an applied approach to the statistical techniques used and will show how to reasonably interpret them. Participants can use this learning to address the various challenges facing pharmaceutical and biotechnology companies when they have to quantify results in a meaningful interpretable manner through tabulations and graphical presentations.

Another area of importance at this seminar is the expectations of different regulatory agencies regarding the quantification and development of a sound statistical monitoring of a properly utilized, effective, and efficient process control. It will familiarize the participants with the critical aspects of the statistical methods and explain to them the practical application of these guidelines.

Validation in accordance with ICH guidelines

Chemical

Professionals in the field of statistical analysis need a clear and perceptive insight into how to understand and interpret statistical concepts used to investigate quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits. Along with these, process and quality controls, as well as ICH Q8 and Q9 also need to be properly and thoroughly understood.

The ICH tripartite-harmonized ICH Guideline on Text, which was previously coded as Q2A, finalized in October 1994 under Step 4, is the guideline the ICH has set out for analytical methods validation. The aim of this guideline is to identify the validation parameters that are required for a number of analytical methods. This guideline also lays down the characteristics and parameters that need to be taken into consideration when validating the analytical procedures that are included in the registration applications.

Likewise, the ICH tripartite-harmonized ICH Guideline on Methodology, which used to be previously coded as Q2B, finalized in November 1996 under Step 4, is the ICH guideline on procedures and acceptance criteria in calibration limits. This guideline extends the ICH guideline on Text, or what is called Q2A (mentioned above) to comprise the actual experimental data required, along with the statistical interpretation, for the validation of a variety of analytical procedures.

Current Step 4 for process and Quality Control

For process and Quality Control, the extant guideline is the Current Step 4 version of the ICH-harmonized Tripartite Guideline. The final draft of this guideline has been recommended for adoption to the regulatory bodies of the three biggest pharmaceutical markets in the world, namely the US, the EU and Japan.

In order to achieve harmonization in Quality, professionals have to meet critical milestones. These include conducting stability studies, the way the studies define relevant limits for the testing of impurities, and following a more malleable approach to pharmaceutical quality that is based on the principles of Good Manufacturing Practice (GMP) risk management. ICH’s Quality guidelines on harmonization relating to Quality cover the following areas:

Get professionally trained on the areas of Validation in accordance with ICH guidelines

Considering the complexity and the breadth of the issues associated with these techniques, which cover both the pharmaceutical and clinical applications, and considering that these techniques apply to a number of area such as stability testing, outlier analysis and risk management; it is necessary and important to undergo professional trainings with which professionals in these areas can clarify a number of doubts.

This is the learning a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will be imparting. This training will be led by Dr. Alfred Bartolucci, who serves as Emeritus Professor of Biostatistics at the University of Alabama. To enroll for this seminar, please register by logging on to Validation in accordance with ICH guidelines . This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A clear and deep understanding of statistical concepts

Depth and clarity of understanding of the statistical concepts used for investigating quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits, and process and Quality Control, along with ICH Q8 and Q9 will be the main thrust of this seminar.

This seminar is not a course in statistics, but offers an introduction to an applied approach to the statistical techniques used, and how to reasonably interpret them. This learning will help participants address the various challenges facing pharmaceutical and biotechnology companies when they have to quantify results in a meaningful interpretable manner through tabulations and graphical presentations.

In addition, Dr. Bartolucci will also focus on another important area: What the different regulatory agencies expect of the quantification and development of a sound statistical monitoring of a properly utilized, effective, and efficient process control. He will familiarize the participants with the critical aspects of the statistical methods and explain to them the practical application of these guidelines.