Disclosure

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: 
星期四, 四月 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.

Alcohol Addiction Treatment Firm will be Banned from Disclosing Health Data for Advertising to Settle FTC Charges that It Shared Data Without Consent

Retrieved on: 
星期五, 四月 12, 2024

The Federal Trade Commission has taken action against an alcohol addiction treatment service for allegedly disclosing users’ personal health data to third-party advertising platforms, including Meta and Google, for advertising without consumer consent, after promising to keep such information confidential.

Key Points: 
  • The Federal Trade Commission has taken action against an alcohol addiction treatment service for allegedly disclosing users’ personal health data to third-party advertising platforms, including Meta and Google, for advertising without consumer consent, after promising to keep such information confidential.
  • As part of a proposed order settling the FTC allegations, New York-based Monument, Inc. will be banned from disclosing health information for advertising and must obtain users’ affirmative consent before sharing health information with third parties for any other purpose.
  • “This action continues the FTC’s work to ensure strict limits on how firms handle sensitive health data, rather than putting the onus on consumers to protect themselves,” said Samuel Levine, Director of the FTC’s Bureau of Consumer Protection.
  • Monument used these pixels and APIs to track “standard” and “custom events,” meaning instances in which consumers interacted with Monument’s website.
  • If the company is found to have misrepresented its finances, it will be required to pay the full amount.
  • The Commission voted 3-0 to refer the complaint and stipulated final order to the Department of Justice for filing.
  • The DOJ filed the complaint and stipulated order in the U.S. District Court for the District of Columbia.

To understand the risks posed by AI, follow the money

Retrieved on: 
星期三, 四月 10, 2024

Shortly thereafter, the consensus switched to fears of an imminent nuclear holocaust.

Key Points: 
  • Shortly thereafter, the consensus switched to fears of an imminent nuclear holocaust.
  • Similarly, today’s experts warn that an artificial general intelligence (AGI) doomsday is imminent.
  • It’s difficult to argue with David Collingridge’s influential thesis that attempting to predict the risks posed by new technologies is a fool’s errand.
  • Focusing on the economic risks from AI is not simply about preventing “monopoly,” “self-preferencing,” or “Big Tech dominance”.
  • It’s about ensuring that the economic environment facilitating innovation is not incentivising hard-to-predict technological risks as companies “move fast and break things” in a race for profit or market dominance.
  • OpenAI is already becoming a dominant player with US$2 billion (£1.6 billion) in annual sales and millions of users.

Degrading quality for higher profit

  • The problems fostered by social media, search, and recommendation algorithms was never an engineering issue, but one of financial incentives (of profit growth) not aligning with algorithms’ safe, effective, and equitable deployment.
  • For digital platforms, extracting digital rents usually entails degrading the quality of information shown to the user, on the basis of them “owning” access to a mass of customers.
  • But over time, a misalignment between the initial promise of them providing user value and the need to expand profit margins as growth slows has driven bad platform behaviour.

Amazon’s advertising

  • In our research on Amazon, we found that users still tend to click on the product results at the top of the page, even when they are no longer the best results but instead paid advertising placements.
  • For social media platforms, this was addictive content to increase time spent on platform at any cost to user health.
  • In the process, profits and profit margins have become concentrated in a few platforms’ hands, making innovation by outside companies harder.
  • Amazon’s most recent quarterly disclosures (Q4, 2023), shows year-on-year growth in online sales of 9%, but growth in fees of 20% (third-party seller services) and 27% (advertising sales).
  • Algorithms have become market gatekeepers and value allocators, and are now becoming producers and arbiters of knowledge.

Risks posed by the next generation of AI

  • But how much greater are the risks for the next generation of AI systems?
  • Thankfully, society is not helpless in shaping the economic risks that invariably arise after each new innovation.
  • Risks brought about from the economic environment in which innovation occurs are not immutable.
  • Market structure is shaped by regulators and a platform’s algorithmic institutions (especially its algorithms which make market-like allocations).
  • What role might interoperability and open source play in keeping the AI industry a more competitive and inclusive market?
  • Instead, we should try to recalibrate the economic incentives underpinning today’s innovations, away from risky uses of AI technology and towards open, accountable, AI algorithms that support and disperse value equitably.
  • Ilan Strauss receives funding from The Omidyar Network through the UCL IIPP research project on algorithmic rents Mariana Mazzucato received funding for this project from the Omidyar Foundation.
  • Rufus Rock received funding from the Omidyar Network whilst pursuing the research referenced in this piece.

Fuller, Smith & Turner PLC: Total Voting Rights and Treasury Shares

Retrieved on: 
星期三, 四月 10, 2024

The following notification is made in accordance with the UK Financial Conduct Authority Disclosure and Transparency Rule 5.6.1.

Key Points: 
  • The following notification is made in accordance with the UK Financial Conduct Authority Disclosure and Transparency Rule 5.6.1.
  • As at 31 March 2024, the Company’s issued share capital consisted of 41,182,339 ‘A’ Ordinary Shares of 40 pence each, 89,052,625 ‘B’ Ordinary Shares of 4 pence each, and 13,366,013 ‘C’ Ordinary Shares of 40 pence each, each carrying one vote.
  • Of this total, 4,143,691 ‘A’ Ordinary Shares and 4,327,915 ‘B’ Ordinary Shares are held in treasury.
  • Therefore, the total number of listed voting rights in the Company for the purpose of Disclosure and Transparency Rule 5.6.1 (calculated in accordance with Disclosure and Transparency Rule 5.6.2) as at 31 March 2024 was 37,038,648.

Form 8.3 - The Vanguard Group, Inc.: Virgin Money UK plc

Retrieved on: 
星期三, 四月 10, 2024

Form 8.3 - The Vanguard Group, Inc.: Virgin Money UK plc

Key Points: 
  • Form 8.3 - The Vanguard Group, Inc.: Virgin Money UK plc
    (a) Full name of discloser:
    (b) Owner or controller of interests and short positions disclosed, if different from 1(a):
    The naming of nominee or vehicle companies is insufficient.
  • For a trust, the trustee(s), settlor and beneficiaries must be named.
  • (c) Name of offeror/offeree in relation to whose relevant securities this form relates:
    (d) If an exempt fund manager connected with an offeror/offeree, state this and specify identity of offeror/offeree:
    (e) Date position held/dealing undertaken:
    For an opening position disclosure, state the latest practicable date prior to the disclosure
    (f) In addition to the company in 1(c) above, is the discloser making disclosures in respect of any other party to the offer?
  • If it is a cash offer or possible cash offer, state “N/A”
    If there are positions or rights to subscribe to disclose in more than one class of relevant securities of the offeror or offeree named in 1(c), copy table 2(a) or (b) (as appropriate) for each additional class of relevant security.

Form 8.3 - The Vanguard Group, Inc.: International Paper Company

Retrieved on: 
星期三, 四月 10, 2024

Form 8.3 - The Vanguard Group, Inc.: International Paper Company

Key Points: 
  • Form 8.3 - The Vanguard Group, Inc.: International Paper Company
    (a) Full name of discloser:
    (b) Owner or controller of interests and short positions disclosed, if different from 1(a):
    The naming of nominee or vehicle companies is insufficient.
  • For a trust, the trustee(s), settlor and beneficiaries must be named.
  • (c) Name of offeror/offeree in relation to whose relevant securities this form relates:
    (d) If an exempt fund manager connected with an offeror/offeree, state this and specify identity of offeror/offeree:
    (e) Date position held/dealing undertaken:
    For an opening position disclosure, state the latest practicable date prior to the disclosure
    (f) In addition to the company in 1(c) above, is the discloser making disclosures in respect of any other party to the offer?
  • If it is a cash offer or possible cash offer, state “N/A”
    If there are positions or rights to subscribe to disclose in more than one class of relevant securities of the offeror or offeree named in 1(c), copy table 2(a) or (b) (as appropriate) for each additional class of relevant security.

Form 8.3 - The Vanguard Group, Inc.: Spirent Communications PLC

Retrieved on: 
星期三, 四月 10, 2024

Form 8.3 - The Vanguard Group, Inc.: Spirent Communications PLC

Key Points: 
  • Form 8.3 - The Vanguard Group, Inc.: Spirent Communications PLC
    (a) Full name of discloser:
    (b) Owner or controller of interests and short positions disclosed, if different from 1(a):
    The naming of nominee or vehicle companies is insufficient.
  • For a trust, the trustee(s), settlor and beneficiaries must be named.
  • (c) Name of offeror/offeree in relation to whose relevant securities this form relates:
    (d) If an exempt fund manager connected with an offeror/offeree, state this and specify identity of offeror/offeree:
    (e) Date position held/dealing undertaken:
    For an opening position disclosure, state the latest practicable date prior to the disclosure
    (f) In addition to the company in 1(c) above, is the discloser making disclosures in respect of any other party to the offer?
  • If it is a cash offer or possible cash offer, state “N/A”
    If there are positions or rights to subscribe to disclose in more than one class of relevant securities of the offeror or offeree named in 1(c), copy table 2(a) or (b) (as appropriate) for each additional class of relevant security.

Form 8.3 - The Vanguard Group, Inc.: Ageas SA/NV

Retrieved on: 
星期三, 四月 10, 2024

Form 8.3 - The Vanguard Group, Inc.: Ageas SA/NV

Key Points: 
  • Form 8.3 - The Vanguard Group, Inc.: Ageas SA/NV
    (a) Full name of discloser:
    (b) Owner or controller of interests and short positions disclosed, if different from 1(a):
    The naming of nominee or vehicle companies is insufficient.
  • For a trust, the trustee(s), settlor and beneficiaries must be named.
  • (c) Name of offeror/offeree in relation to whose relevant securities this form relates:
    (d) If an exempt fund manager connected with an offeror/offeree, state this and specify identity of offeror/offeree:
    (e) Date position held/dealing undertaken:
    For an opening position disclosure, state the latest practicable date prior to the disclosure
    (f) In addition to the company in 1(c) above, is the discloser making disclosures in respect of any other party to the offer?
  • If it is a cash offer or possible cash offer, state “N/A”
    If there are positions or rights to subscribe to disclose in more than one class of relevant securities of the offeror or offeree named in 1(c), copy table 2(a) or (b) (as appropriate) for each additional class of relevant security.

Form 8.3 - The Vanguard Group, Inc.: Tritax Big Box REIT plc

Retrieved on: 
星期三, 四月 10, 2024

Form 8.3 - The Vanguard Group, Inc.: Tritax Big Box REIT plc

Key Points: 
  • Form 8.3 - The Vanguard Group, Inc.: Tritax Big Box REIT plc
    (a) Full name of discloser:
    (b) Owner or controller of interests and short positions disclosed, if different from 1(a):
    The naming of nominee or vehicle companies is insufficient.
  • For a trust, the trustee(s), settlor and beneficiaries must be named.
  • (c) Name of offeror/offeree in relation to whose relevant securities this form relates:
    (d) If an exempt fund manager connected with an offeror/offeree, state this and specify identity of offeror/offeree:
    (e) Date position held/dealing undertaken:
    For an opening position disclosure, state the latest practicable date prior to the disclosure
    (f) In addition to the company in 1(c) above, is the discloser making disclosures in respect of any other party to the offer?
  • If it is a cash offer or possible cash offer, state “N/A”
    If there are positions or rights to subscribe to disclose in more than one class of relevant securities of the offeror or offeree named in 1(c), copy table 2(a) or (b) (as appropriate) for each additional class of relevant security.