Characterization

Draft revised Heads of Medicines Agency / European Medicines Agency guidance document on the identification of personal data and commercially confidential information within the structure of the marketing authorisation application dossier

Retrieved on: 
Thursday, April 18, 2024
Steps, Union, Patient, CTD, Syndrome, CCI, Local, Disclosure, Toxicity, Process validation, MAH, Clinical trial, IP, RMP, Pharmacovigilance, Cell, Legislation, Annex, Trial of the century, Escherichia coli, Safety, Pediatrics, INTRODUCTION, Documentation, Prevalence, Vital signs, Tablet, Design, Transparency, Conclusion, Pip, Analysis, European Parliament, INN, Record, Quality, Generic, Biology, CMO, Genotoxicity, Composition, CTIS, Uncontrolled, Health care, European Medicines Agency, Prejudice, Committee, Policy, HCP, Animal, Characterization, Cell bank, Fertility, IRB, CMOS, Risk management, Private law, European Pharmacopoeia, Telephone, Research, Good, Data Protection Directive, Ampere-hour, IEC, QP, Human, Personal data, Labelling, Bibliography, Figure, MAA, R4, Institutional review board, Elucidation, Marketing, M4, ChromeOS, Contract research organization, Mental, Impairment, Toxicokinetics, NCA, Independent, Metabolite, Drug, Risk, Metabolism, GMO, Organ, EMA, Common Technical Document, General Data Protection Regulation, Confidentiality, PPD, PI, Language, DRUG, Privacy, Result, Claimed, Medication, Comparison, Ethics, Drive, PD, Narrative, EEA, Developmental toxicity, Saccharomyces cerevisiae, Pharmacopoeia, PIP, MCB, HMA, Physical chemistry, Midol, Particle size, Council, GCP, European Economic Area, Draft, Fermentation, Overview, Justification, Control, Dicarboxylic acid, Pharmacology, WCB, Expert, Immunogenicity, Data, Study, Publication, European, ICH, Element, Analytical procedures (finance auditing), Name, Common, Guideline, Exceptional circumstances, ID, Liver, Chin Na, Toxicology, Protein primary structure, Immunosuppressive drug, Vaccine

See websites for contact details

Key Points: 
    • See websites for contact details
      Heads of Medicines Agencies www.hma.eu
      European Medicines Agency www.ema.europa.eu

      11

      Table of contents

      12

      Abbreviations .............................................................................................. 3

      13

      Definitions ................................................................................................... 4

      14

      1.

    • redaction, masking,

      68

      hiding) in such a manner that the recipient can no longer attribute the resulting information to a data

      69

      subject and make it identifiable.

    • 81

      Contract Manufacturing Organisation (CMO): shall mean an arrangement under which a

      82

      manufacturer provides upstream manufacturing services under contract on behalf of third-party

      83

      pharmaceutical companies.

    • 94

      Protected Personal Data (PPD): shall mean any personal data which should be protected from

      95

      disclosure.

    • ?Finalised? shall mean that the marketing

      102

      authorisation (MA) has been granted or refused or that the MAA has been withdrawn.

    • The application of the general principles laid down in this guidance is without prejudice to

      106

      national rules on transparency.

    • The guidance should be read in conjunction with the relevant applicable

      107

      legislation and case law on transparency and data protection.

    • 117

      This guidance document is intended to apply to information/documents on medicinal products for

      118

      human use, for which the procedure has been finalised under the national, mutual recognition,

      119

      decentralised and centralised procedures.

    • Third

      124

      parties shall be informed or consulted as needed depending on respective national and European legal

      125

      frameworks.

    • 140

      In the following sections, the agreed principles on PD and CCI are presented, including guidance on

      141

      whether such information can be disclosed.

    • EMA/131365/2024

      Page 5/50

      142

      Any information identified as PD or CCI must be subject to a preliminary review by the EMA/NCA prior

      143

      to the possible disclosure of the information/documents.

    • Principles on the protection of personal data (PD)

      145

      The protection of PD is enshrined in EU legislation; it is a fundamental right of EU citizens.

    • In

      146

      compliance with the applicable European/national legislation, PD should be anonymised in order to

      147

      avoid the disclosure of the document undermining the privacy and integrity of any individual.

    • EMA/NCA applies a risk-based approach to assess which PD elements are to be

      152

      removed from the information/documents in order to limit the risk of re-identification.

    • are included in the MAA dossier because they have a legally

      164

      defined role or responsibility and it is in the public interest to disclose this data.

    • 168

      Applicants are advised that non-essential information (e.g., personal address, personal phone number)

      169

      should not be included in the MAA dossier.

    • The

      183

      confidentiality of records that could identify subjects should be protected, respecting the privacy and

      184

      confidentiality rules in accordance with the applicable regulatory requirement(s).

    • 185

      The applicant remains responsible for compliance with the relevant legislation in cases where such data

      186

      is inadvertently included in the MAA dossier.

    • 188

      EMA/NCA applies a risk-based approach to assess which personal data elements need to be removed

      189

      from the information/documents in order to limit the risk of re-identification.

    • 194

      EMA/NCA applies a risk-based approach to assess which personal data elements need to be removed

      195

      from the information/documents in order to limit the risk of re-identification.

    • 205

      Any proposal to consider information as commercially confidential should be properly justified by the

      206

      owner of the information.

    • In this respect, any reference(s) to the risk of that interest being

      209

      undermined should be foreseeable and not purely hypothetical.

    • 210

      Information that is already in the public domain is not considered to be commercially confidential.

    • Information on the Quality and Manufacturing of medicines

      226

      A general principle regarding quality and manufacturing information is that detailed information could

      227

      be considered commercially confidential but general information should be disclosed.

    • 234

      In general, and if not in the public domain, the names of manufacturers or suppliers of the active

      235

      substance or the excipients are considered commercially confidential.

    • 248

      A general description of the type of test methods used and the appropriateness of the specification is

      249

      not commercially confidential.

    • General information on the fermentation and purification process

      259

      is not commercially confidential, although details including operating parameters and specific material

      260

      requirements are commercially confidential.

    • 273

      A general description of the type of test methods used and the appropriateness of the specification is

      274

      not commercially confidential.

    • In general, the data included in clinical trial study reports is considered to be data that can be

      283

      disclosed once PD has been anonymised.

    • 338

      In each module, a non-exhaustive list of information that may be considered protected personal data (PPD) or commercially confidential information

      332
      333

      339

      (CCI) is included.

    • ?

      Direct contact details such as telephone

      Therefore, please refer to the appropriate sub-

      number, fax number, email, postal address,

      modules hereafter for guidance.

    • ?

      Information that may reveal strategic
      (contractual) agreements

      ?

      Any quality information on the clinical batches

      principal investigator

      that might be included here (such as e.g.

    • ?

      Information that may reveal strategic
      (contractual) agreements

      principal investigator

      Study Reports
      5.3.3.3

      as the evaluation of new formulation, innovative

      number, fax number, email, postal

      Paediatric Development Plan (PIP), etc.

    • This may include taking into

      More Than One Study
      5.3.5.4

      Other Clinical Study Reports

      5.3.6

      Reports of Post-Marketing
      Experience

      5.3.7

      Direct identifiers such as name,
      signature, contact details, etc.

Truman Capote was ruined when he published his society friends’ secrets. Was Answered Prayers worth it?

Retrieved on: 
Friday, February 16, 2024

In November 1975, Truman Capote, the proudly gay author of Breakfast at Tiffany’s and In Cold Blood, unveiled the hotly anticipated second instalment of his unpublished novel, Answered Prayers.

Key Points: 
  • In November 1975, Truman Capote, the proudly gay author of Breakfast at Tiffany’s and In Cold Blood, unveiled the hotly anticipated second instalment of his unpublished novel, Answered Prayers.
  • Capote ended his days a social pariah in his former New York society circles, incapacitated by a lifetime of prodigious substance abuse.
  • The story to blame, La Côte Basque, 1965, takes its title from its setting: an achingly fashionable French restaurant in Manhattan.
  • However, Mrs. Hopkins was une autre chose: a sensation to unsettle the suavest Côte Basque client.
  • Mrs. Kennedy and her sister had elicited not a murmur, nor had the entrances of Lauren Bacall and Katharine Cornell and Clare Booth Luce.
  • However, Mrs. Hopkins was une autre chose: a sensation to unsettle the suavest Côte Basque client.

The real-life ‘Mrs. Bang-Bang’

  • There was talk of the spate of burglaries that had recently occurred in the area.
  • Ann, who suffered from insecurity and social anxiety, drank more than usual.
  • Returning home with her husband, she washed down some sleeping pills and went to bed, not long after midnight.
  • At two in the morning, Ann was woken by the sound of her dog growling.

‘What I’m writing is true’

  • Regardless of whether he truly appreciated this, it seems fair to say Capote’s encounter with Ann Woodward made quite the impression on him.
  • Capote’s conception of Answered Prayers, which he struggled with and talked about for decades, developed over time.
  • In his monumental novel-cycle Remembrance of Things Past, Proust scrutinised the social machinations of the Parisian upper classes at the turn of the 20th century.
  • Capote conceived of his project – which took shape as a roman à clef – in equivalent terms.
  • What I’m writing is true, it’s real and it’s done in the very best prose style that I think any American writer could possibly achieve.
  • […] If Proust were an American living now in New York, this is what he would be doing.
  • What I’m writing is true, it’s real and it’s done in the very best prose style that I think any American writer could possibly achieve.
  • as is generally conceded, a beautiful girl of twelve or twenty, while she may merit attention, does not deserve admiration.

Masturbation, misogyny, murder

  • At the start of January 1966, Capote signed a contract with Random House for a novel titled Answered Prayers.
  • However, by the time he actually sat down to write the book, he was already under a great deal of pressure.
  • Masturbation, menstruation, misogyny, murder.
  • Readers who thought they were getting a finely wrought piece of social critique were left scratching their heads in bemusement.
  • Read more:
    In Killers of the Flower Moon, true crime reveals the paradoxes of the past

Was the book any good?


With the benefit of hindsight, I think the overwhelming majority missed the memo when it came to Answered Prayers.

  • By the same token, it is clear Answered Prayers responds to (and even builds on) advances made in his earlier work.
  • Gossip can serve a positive, even joyous function: it is a “social activity which produces and maintains the filiations” of community.
  • To put this another way: if used in a strategic and appropriate fashion, gossip can bring people together.
  • It can help to build and sustain social groupings predicated on the basis of shared knowledge (of sexual matters).
  • Consider Unspoiled Monsters, the first chapter in the posthumously published book.
  • If he had been absolutely factual, it would have been less believable but […] it might have been better.

Settling scores

  • In part, he was looking to settle scores.
  • Try as he might, Capote, who claimed his intentions had been misunderstood, couldn’t win the swans back over.
  • As chance, or maybe fate would have it, he died at exactly the same age as Ann Woodward.
  • Given how much they despised each other, I can’t help but wonder what Capote and Woodward would have made of such dismal symmetries.


Alexander Howard does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

First-Ever Clinical Trial Exclusively in Black and Hispanic / Latinx People Living With Multiple Sclerosis Shows Genentech’s Ocrevus Effectively Manages Disease Activity

Retrieved on: 
Wednesday, October 11, 2023

One-year data from the trial show that Ocrevus effectively manages MS disease activity in these populations.

Key Points: 
  • One-year data from the trial show that Ocrevus effectively manages MS disease activity in these populations.
  • The safety and efficacy profile demonstrated in the trial was consistent with the large body of clinical evidence from other Ocrevus studies.
  • “We know that Black and Hispanic / Latinx people with MS often experience more severe disease and greater disability compared with their white counterparts.
  • Despite making up almost 20% of the MS population,1 Black and Hispanic / Latinx people living with the disease are vastly underrepresented in clinical research.

Caelux Partners with University of New South Wales on Solar Cells Project to Improve Readiness of Solar PV Technologies

Retrieved on: 
Tuesday, September 19, 2023

PASADENA, Calif., Sept. 19, 2023 /PRNewswire/ -- Caelux, a pioneer in utilizing perovskites to make solar energy more powerful and cost-effective, today announced its partnership with the University of New South Wales (UNSW, Sydney, Australia) ACDC Research Group on the ARENA-funded project, 'High-Throughput Inspection Methods for High-Efficiency Multijunction Solar Cells.' This solar cells project will improve the commercial readiness of solar PV technologies and enable the next generation of solar innovation.

Key Points: 
  • This solar cells project will improve the commercial readiness of solar PV technologies and enable the next generation of solar innovation.
  • The Artificial Intelligence, Characterisation, Defects, and Contacts (ACDC) Research Group at the University of New South Wales (UNSW) is a leader in photovoltaic luminescence imaging and applied machine learning (ML).
  • "We are delighted to partner with the ACDC Research Group on this revolutionary solar cell project," said Scott Graybeal, CEO of Caelux.
  • "Together, we are looking forward to accelerating the commercial development and long-term reliability of perovskite solar cells.

Covalent Metrology Expands Advanced Optical Analysis Lab

Retrieved on: 
Wednesday, May 19, 2021

b'SUNNYVALE, Calif., May 19, 2021 /PRNewswire/ -- Covalent Metrology is broadening and deepening its extensive portfolio of in-house optical characterization techniques and has further expanded its suite of new, state-of-the-art analytical instruments from Thermo Fisher Scientific.

Key Points: 
  • b'SUNNYVALE, Calif., May 19, 2021 /PRNewswire/ -- Covalent Metrology is broadening and deepening its extensive portfolio of in-house optical characterization techniques and has further expanded its suite of new, state-of-the-art analytical instruments from Thermo Fisher Scientific.
  • Dr. Moore continued, "Together, these cutting-edge tools will enable Covalent to craft solutions to even more complex analytical questions for our clients.
  • Covalent invites clients to gain a firsthand look of their Raman analysis via remote-viewing services, available soon on the DXR3xi system.\nCovalent further deepens its optical and chemical testing capabilities with the newly installed Thermo Fisher Scientific Nicolet iS50 FTIR Spectrometer and Nicolet Continum IR microscope.
  • The installed Nicolet iS50 system is customized to enable integrated thermogravimetric analysis work to be performed for combination TGA-FTIR measurements.\nCovalent Metrology is a disruptive analytical services laboratory and platform based in Sunnyvale, California.

Covalent Metrology Introduces Fast, Flexible Thermal Analysis Capabilities Using New High-Performance Instruments

Retrieved on: 
Wednesday, May 12, 2021

Thermal testing with DSC and TGA allows engineers to optimize around these changes by illuminating the relationship between a sample material\'s structure and thermal response.\n"The TA Instruments DSC 2500 and TGA 5500 will allow Covalent to deliver the most accurate, flexible, and efficient thermal characterization services possible.

Key Points: 
  • Thermal testing with DSC and TGA allows engineers to optimize around these changes by illuminating the relationship between a sample material\'s structure and thermal response.\n"The TA Instruments DSC 2500 and TGA 5500 will allow Covalent to deliver the most accurate, flexible, and efficient thermal characterization services possible.
  • Covalent\'s new TGA 5500 can probe these and more with a suite of advanced measurement modes, such as: modulated- and high-resolution-TGA, evolved gas analysis, and more.
  • The system provides the fastest heating and cooling rates available, as well as the best mass resolution limits and the lowest signal drift.
  • This webinar discussed the unique technologies in the DSC 2500 and TGA 5500 and examined the new applications they facilitate.\nFor more information on Covalent\'s thermal analysis services, explore:\nCovalent Metrology is a disruptive analytical services laboratory and platform based in Sunnyvale, California.

Thermo Scientific Spectra Ultra Offers a Leap Forward for Advanced Materials Characterization

Retrieved on: 
Wednesday, March 3, 2021

The new Spectra Ultra provides flexibility to optimize conditions for advanced imaging and analysis in minutes versus hours.

Key Points: 
  • The new Spectra Ultra provides flexibility to optimize conditions for advanced imaging and analysis in minutes versus hours.
  • Spectra Ultra includes a new energy-dispersive X-Ray (EDX) analysis system, the Thermo Scientific Ultra-X, with the largest detector area available in a commercially released (S)TEM.
  • Spectra Ultra builds on the advancements already available in the Thermo Scientific Themis and Spectra platforms, removing complexity so users can obtain quality data at high resolutions.
  • "The Spectra Ultra provides industry-leading (S)TEM analysis and characterization capabilities to assist them in meeting the demands for advanced material solutions."

2020 Market Study on Material Characterization - Featuring Anton Paar, Horiba Scientific & PAC Among Others - ResearchAndMarkets.com

Retrieved on: 
Friday, October 23, 2020

Material characterization is the assessment of a material's mechanical or physical properties and features.

Key Points: 
  • Material characterization is the assessment of a material's mechanical or physical properties and features.
  • Product segments include physical testing instruments, thermal analyzers, particle characterization analyzers, and rheometers and viscometers.
  • The global material characterization market is witnessing a shift in demand from laboratory to online process analyzers.
  • In the pharmaceutical industry, for example, direct online analyzer process control can minimize time to market and eliminate additional laboratory research.

Frost Radar™: Material Characterization Market, 2020

Retrieved on: 
Monday, August 17, 2020

NEW YORK, Aug. 17, 2020 /PRNewswire/ -- Material characterization is the assessment of a material's mechanical or physical properties and features.Product segments include physical testing instruments, thermal analyzers, particle characterization analyzers, and rheometers and viscometers.

Key Points: 
  • NEW YORK, Aug. 17, 2020 /PRNewswire/ -- Material characterization is the assessment of a material's mechanical or physical properties and features.Product segments include physical testing instruments, thermal analyzers, particle characterization analyzers, and rheometers and viscometers.
  • The global material characterization market is witnessing a shift in demand from laboratory to online process analyzers.In the pharmaceutical industry, for example, direct online analyzer process control can minimize time to market and eliminate additional laboratory research.
  • Advanced material analysis requires a specialized instrument with high sensitivity detection that not all participants have the technical expertise to provide.
  • Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

Covalent Metrology Advances (Scanning) Transmission Electron Microscopy Analytical Services

Retrieved on: 
Wednesday, August 12, 2020

SUNNYVALE, Calif., Aug. 12, 2020 /PRNewswire/ -- Covalent Metrology has completed installation of a new Thermo Scientific Talos F200X G2 S/TEM at its Sunnyvale, CA headquarters.

Key Points: 
  • SUNNYVALE, Calif., Aug. 12, 2020 /PRNewswire/ -- Covalent Metrology has completed installation of a new Thermo Scientific Talos F200X G2 S/TEM at its Sunnyvale, CA headquarters.
  • The Talos S/TEM will round out a complete suite of in-house instrumentation for electron microscopy analysis, enabling Covalent to deliver industry leading S/TEM analysis with rapid turnaround times and no expedite fees.
  • Covalent Metrology is now positioned to help scientists and engineers tap into S/TEM characterization solutions by providing affordable atomic-level resolution images, diffraction patterns for crystallography, and elemental composition through energy dispersive x-ray spectroscopy (EDS).
  • Covalent Metrology is a disruptive analytical services laboratory and platform based in Sunnyvale, California.