Ageing

Many prisoners go years without touching a smartphone. It means they struggle to navigate life on the outside

Retrieved on: 
Friday, April 19, 2024
Interview, Health, Crime, COVID, Face, Learning, Survival, Digital, NSW, Unemployment, Risk, Prison, Education, Ageing, Prisoner, Mortality, Recidivism, Social isolation, Literacy, Anxiety, Food, Male, Rehabilitation, MyGov, Nursing

You’d be hard pressed to find any aspect of daily life that doesn’t require some form of digital literacy.

Key Points: 
  • You’d be hard pressed to find any aspect of daily life that doesn’t require some form of digital literacy.
  • We need only to look back ten years to realise how quickly things have changed.
  • In 2013, we were still predominantly buying paper bus tickets and using Facebook on a desktop computer.

Unfamiliar tech damaging confidence


Prison populations are getting older worldwide for a few reasons, including general population ageing, trends towards people entering prison at an older age, or staying in for longer. At the same time, Australian prisons remain highly technologically restricted environments, mostly for security reasons. We interviewed 15 Australians (aged 47–69 years) about their experiences of reintegration following release from prison.

  • They described feeling like a stranger thrown into a world where survival depended on their ability to use technology.
  • Regardless of their experiences before imprisonment, the rapid digitisation of daily functions that were once familiar to them rendered their skills and confidence irrelevant.
  • One former inmate said:
    There’s a significant gap […] for anybody who’s done, I’m gonna say, probably more than five to seven years [in prison].
  • There’s a significant gap […] for anybody who’s done, I’m gonna say, probably more than five to seven years [in prison].

Exacerbating recidivism

  • There’s concerning evidence around recidivism, risk of post-release mortality, social isolation, unemployment and homelessness.
  • Digital exclusion creates an additional barrier for those who are older, who already face a high risk of medical and social marginalisation.
  • A former prisoner said:
    Think about it, after being in ten years, well you think, okay, where do I start?

What can be done?

  • The interviewees provided suggestions for how such programs could be delivered and a keenness to engage with them.
  • They tended to focus on learning in environments free from stigma and judgement of their literacy level or histories, with hands-on experience and face to face support.
  • Interviewees favoured learning while in prison, with additional support available on the outside.
  • Based on the evidence, we can be certain this will encourage positive change for the 95% of Australian prisoners who will eventually be released.


Ye In (Jane) Hwang has received funding from the National Health and Medical Research Council of Australia, the Australian Association of Gerontology, and the University of New South Wales Ageing Futures Institute for this work.

The world’s oldest conjoined twins have died – what we know about this rare condition

Retrieved on: 
Friday, April 19, 2024
Twin, Brain, Gene, MRI, Growth, Surgeon, Magnetic resonance, Conjoined twins, The Royal Court, Ageing, Abdomen, Hospital, Female, History, Child, Great Ormond Street Hospital, Death, Pregnancy, Life, Royal, Magnetic resonance imaging, Thalamus, Skull, Liver, Medical imaging

The world’s oldest conjoined twins, Lori and George Schappell, recently died, aged 62.

Key Points: 
  • The world’s oldest conjoined twins, Lori and George Schappell, recently died, aged 62.
  • Conjoined twins are incredibly rare, accounting for about one or two in every 100,000 births.
  • Because conjoined twins are so rare, it is difficult to know exactly how they come about.

Types of conjoined twins

  • There are 15 recognised types of conjoined twins, based on the various places their bodies fuse.
  • Conjoined twins are usually picked up on routine ultrasound scans performed during pregnancy.
  • Conjoined twins who are diagnosed by imaging are typically delivered by caesarean section.

Separating twins

  • One of the longest operations to separate conjoined twins, who were fused at the cranium, took more than 100 hours.
  • The earliest recorded attempt at surgical separation of conjoined twins dates back to AD945 in Armenia where conjoined brothers lived until middle age before one of them died.
  • Separating conjoined twins requires a significant amount of planning before surgery can begin, including, of course, lots of imaging such as ultrasound, CT and MRI.
  • Twins who share vital organs – or whose organs are fused – have a lower chance of a successful separation.


Adam Taylor 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.

Falls, fractures and self-harm: 4 charts on how kids’ injury risk changes over time and differs for boys and girls

Retrieved on: 
Thursday, April 18, 2024
Giant, Injury, Health, Psychological abuse, Disability, Attention, Burns, Drowning, Arm, Growth, Sport, Learning, Caregiver, Risk, Ageing, Knowledge, Fracture, Aborigine, Child, Death, Choking, Crash, Head Injuries, Asphyxia, Adolescence, Safety, Government, Parent, Violence, Assault, Toy

At least a quarter of all emergency department presentations during childhood are injury-related.

Key Points: 
  • At least a quarter of all emergency department presentations during childhood are injury-related.
  • Injuries can be unintentional (falls, road crashes, drowning, burns) or intentional (self harm, violence, assault).
  • The type, place and cause of injury differs by age, developmental stage and sex.


children aged 1–4 years are the age group most likely to present to an emergency department with injuries
adolescents aged 16–18 years are the age group most likely to be admitted to hospital for injuries
boys are more likely to be hospitalised for injuries than girls. This continues into adulthood
girls are five times more likely to be hospitalised for intentional self-harm injuries than boys
falls are the leading cause of childhood injury, accounting for one in three child injury hospitalisations. Falls from playground equipment are the most common
fractures are the most common type of childhood injury, especially arm and wrist fractures in children aged 10–12 years.

  • For children under age one, drowning, burns, choking and suffocation had the highest injury hospital admission rates compared to adults.
  • In early childhood (ages 1-4 years), the highest causes of injury hospitalisation were drowning, burns, choking and suffocation and accidental poisoning.

What about sports?

  • Cycling causes the highest number of sporting injuries with almost 3,000 injury hospital presentations.
  • For the top 20 sports that are most likely to cause injury hospital admissions, fractures are the most common type of injury.
  • How to spot a serious injury now school and sport are back

Balancing risk and safety

  • To prevent injuries, we need to balance risk and safety.
  • Embracing risk is a fundamental part of play in all environments where children play and explore their world.
  • But with proper guidance and supervision from parents and caregivers, we can strike a balance between offering opportunities for risk-taking and ensuring children’s safety from serious harm.

What can governments do to prevent injuries?

  • This will provide clear guidance for all levels of government and others on prevention strategies and investment needed.
  • Better reporting on childhood and adolescent injury trends will better inform parents, caregivers, teachers and health professionals about the risks.
  • She is currently undertaking a project specific short term contract at the AIHW, in the Family and Domestic Violence Unit.
  • Dr Sharwood is recognised as a Professional Fellow in the Faculty of Engineering and IT, UTS, for her industry expertise in product related injuries.
  • Warwick Teague is Director of Trauma and Consultant Paediatric Surgeon at The Royal Children's Hospital Melbourne (RCH).

How England’s scrapped Sure Start centres boosted the health and education of disadvantaged children

Retrieved on: 
Thursday, April 18, 2024
Sure, Health, Homelessness, Sheffield Hallam University, Learning, Partnership, Family, Child, Ageing, Save the Children, Research, Food, Sure Start, Organic, Housing, Heart, Parent, Tutoring

The Sure Start programme was launched in 1999, with centres set up in communities across England to offer support to the most disadvantaged families.

Key Points: 
  • The Sure Start programme was launched in 1999, with centres set up in communities across England to offer support to the most disadvantaged families.
  • The research found that access to a Sure Start centre significantly improved the GCSE results of disadvantaged children.
  • This builds on other research that has shown that Sure Start also had significant long-term health benefits.

How Sure Start worked

  • There was no set model for how Sure Start local programmes should deliver the services they offered.
  • The support offered was tailored to the challenges that local families were facing.
  • I was lucky enough to be the community development worker for a small children-and-families charity that led an early Sure Start local programme.

Learning from Sure Start

  • Drawing on the successes of Sure Start, the nursery was established with the motto “changing lives through relationships”.
  • It had the explicit aim of building trust with families so that we can understand their challenges and work on solutions together.
  • The university runs the nursery, and together with Save the Children provides additional support to parents.
  • I have always been convinced of the benefit of Sure Start’s approach, and the recent IFS findings add further evidence of its value.


Sally Pearse 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.

Draft guideline on the pharmaceutical quality of inhalation and nasal medicinal products

Retrieved on: 
Thursday, April 18, 2024
Reproduction, Midol, Medical device, Particle size, QRD, Patient, Chronic obstructive pulmonary disease, Food packaging, DPI, CTD, Isocyanate, European Pharmacopoeia, Roflumilast, GSD, Scope, Asthma, OIP, Clinical trial, European, COPD, APSD, Marketing, CQA, Nasal mucosa, Medical device regulation, Medication, Solvent, No-no, RH, Ageing, Draft, Gel, EMA, Freezing, Outline, Risk assessment, Uniformity, Chemistry, Pressurization, Micronization, Clutch (eggs), Blister, CHMP, Mass, MDI, Solubility, Documentation, Life cycle, Pharmacopoeia, Capsule, Bias, LDPE, Inhalation, Conformity, Publication, The central science, ICH, Orientation, NB, Lubricant, AIM, Excipient, Temperature, Monograph, Humidity, Cold, Light, Life, Medication package insert, Rugosity, Quality, Water, Yesa, Administration, Weight loss, Life insurance

17

Key Points: 
    • 17

      Guideline on the pharmaceutical quality of inhalation and
      nasal medicinal products

      18

      Table of contents

      19

      Executive summary ..................................................................................... 3

      20

      1.

    • Lifecycle management ........................................................................................ 28

      49

      Definitions ................................................................................................. 29

      16

      50
      51

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 2/30

      52

      Executive summary

      53

      This guideline is the first revision of the guideline on pharmaceutical quality of inhalation and nasal

      54

      products (EMEA/CHMP/QWP/49313/2005 Corr).

    • Quality aspects specific to inhalation and nasal medicinal products are discussed, the need for

      66

      safety testing (e.g., for excipients and leachables) is also considered.

    • 69

      Detailed guidance on pharmaceutical development study designs (e.g., priming studies) and the

      70

      analytical procedures primarily used for inhalation and nasal medicinal products (e.g., cascade

      71

      impactor analysis) is not included in this guideline.

    • Scope

      74

      The guideline addresses requirements "on the quality of inhalation and nasal medicinal products" in

      75

      new marketing authorisation applications, including abridged applications.

    • Liquid inhalation anaesthetics and nasal ointments, creams and gels are

      88

      excluded, however the general principles described in this guideline should be considered.

    • 118

      Different polymorphic forms including any amorphous content could affect the quality or performance

      119

      of the finished medicinal product.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 4/30

      132

      The primary packaging, type of inhaler and, if necessary, the secondary packaging or other

      133

      components required for reasons of stability should be described.

    • Pharmaceutical
      development study

      (a) Physical
      characterisation
      (b) Minimum fill
      justification
      (c) Extractable
      volume

      Pressurised

      Dry powder

      Preparations for

      Non-

      metered-

      inhalers (DPI)

      nebulisation

      pressurised

      dose

      metered-

      Device-

      Pre-

      Single-

      Multi-

      (pMDI)

      metered

      metered

      dose

      dose

      inhalers

      Yesa

      Yes

      Yes

      Yesa

      Yesa

      Yesa

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      No

      No

      No

      Yes

      No

      No

      inhalers

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      dose

      Page 5/30

      Table 4.2.1.

    • The last doses delivered by

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 7/30

      179

      the inhaler as defined by the label claim, should meet the finished medicinal product specification limits

      180

      for delivered dose and fine particle dose.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 9/30

      263
      264

      4.2.2.8.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 11/30

      345

      Instructions regarding cold temperature use should be provided in the product information.

    • Finished medicinal
      product

      Pressurised

      Dry powder inhalers

      Preparations for

      metered-

      (DPI)

      nebulisation

      dose

      Nonpressurised
      metered-dose

      Device-

      Pre-

      Single-

      Multi-

      (pMDI)

      metered

      metered

      dose

      dose

      inhalers

      (a) Description

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      (b) Assay

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      (c) Moisture content

      Yes

      Yes

      Yes

      No

      No

      No

      Yes

      Yes

      Yes

      No

      No

      Yes

      Yes

      Yes

      Yes

      No

      No

      Yes

      specification test

      (d) Mean delivered
      dose
      (e) Uniformity of
      delivered dose

      inhalers

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 15/30

      Table 4.2.2.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 16/30

      510

      4.2.5.4.

    • The proposed specification limits should take into account the shelf-life performance of the
      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 17/30

      552

      medicinal product.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 18/30

      586

      All medical devices, including inhalers and nasal devices, have to fulfil the general requirements as

      587

      outlined in the Medical Device Regulation (EU) 2017/745.

    • Stability (CTD 3.2.P.8)

      598

      All inhalation medicinal products should be tested on stability against the stability indicating tests

      599

      included in the finished medicinal product specification.

    • Quality data requirements as

      619

      described in this guideline should be met, supplemented by appropriate comparative quality and

      620

      clinical data with respect to the chosen reference medicinal product.

    • 621

      For inhalation medicinal products comparative in vitro data between the abridged application medicinal

      622

      product and the reference medicinal product must be provided.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 20/30

      670

      Nature and contents of container: The type of the device and its components should be listed.

    • Nasal medicinal products

      695

      Inhalation and nasal medicinal products have many similarities and therefore, most of the

      696

      requirements specified for inhalation medicinal products in section 4 also apply for nasal medicinal

      697

      products.

    • One difference between inhalation and nasal medicinal products is the desired

      698

      particle/droplet size of the finished medicinal product.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 21/30

      704

      5.2.

    • Nasal liquids
      Pharmaceutical
      development
      study

      Pressurised

      Nasal

      metered-

      powders,

      dose nasal

      device-

      spray

      metered

      NonSingledose
      drops

      Multidose
      drops

      Single-

      pressurised

      dose

      multidose

      spray

      metereddose spray

      (a) Physical
      characterisation
      (b) Minimum fill
      justification
      (d) Extractables /
      leachables

      Yesa

      Yes

      Yesa

      Yesa

      Yesa

      Yesa

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      No

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      No

      No

      Yes

      Yes

      Yes

      Yes

      No

      No

      No

      Yes

      Yes

      Yes

      No

      No

      Yes

      Yes

      (f) Particle /
      droplet size
      distribution
      (g) Uniformity of
      delivered dose
      through container
      life
      (j) Actuator /
      mouthpiece
      deposition

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 22/30

      Table 5.2.1.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 23/30

      728

      5.2.2.2.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 24/30

      769

      5.2.5.

    • Quality data requirements as described in

      799

      this guideline should be met, supplemented by appropriate comparative quality and clinical data with

      800

      respect to the chosen reference medicinal product.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 27/30

      849

      5.5.

    • 866

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 28/30

      867

      Definitions
      Activation:

      The act of setting in motion the delivery device.

    • Delivery device:

      The sum of component(s) of the container closure system responsible for
      delivering the active substance to the respiratory tract (inhalation medicinal
      product) or the nasal and/or pharyngeal region (nasal medicinal product).

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 29/30

      Label claim:

      The amount of active substance (usually on a per actuation basis) declared
      on the label of the medicinal product.

    • Nasal medicinal

      A finished medicinal product (including the delivery device, where

      product:

      applicable) whose intended site of deposition is the nasal and/or pharyngeal
      region.

    • 868
      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 30/30

Orphan designation: Synthetic hypericin Treatment of cutaneous T-cell lymphoma, 28/07/2015 Positive

Retrieved on: 
Thursday, April 18, 2024
Eurostat, Diagnosis, Civil service commission, X-ray, Growth, Medicine, Disease, Patient, Ageing, Committee, Knowledge, Tissue, Neoplasm, Light, Cutaneous T-cell lymphoma, Regulation, Cancer, EMA, IRIS, Quality of life, Reactive oxygen species, Lymph, CTCL, Clinical trial, European, Skin, COMP, Oxygen, European Commission, Immune system, Safety, Carmustine, Alfa, Marketing, Lymphatic system, Pharmaceutical industry

Orphan designation: Synthetic hypericin Treatment of cutaneous T-cell lymphoma, 28/07/2015 Positive

Key Points: 


Orphan designation: Synthetic hypericin Treatment of cutaneous T-cell lymphoma, 28/07/2015 Positive

Draft guideline on the pharmaceutical quality of inhalation and nasal medicinal products

Retrieved on: 
Thursday, April 18, 2024
Reproduction, Midol, Medical device, Particle size, QRD, Patient, Chronic obstructive pulmonary disease, Food packaging, DPI, CTD, Isocyanate, European Pharmacopoeia, Roflumilast, GSD, Scope, Asthma, OIP, Clinical trial, European, COPD, APSD, Marketing, CQA, Nasal mucosa, Medical device regulation, Medication, Solvent, No-no, RH, Ageing, Draft, Gel, EMA, Freezing, Outline, Risk assessment, Uniformity, Chemistry, Pressurization, Micronization, Clutch (eggs), Blister, CHMP, Mass, MDI, Solubility, Documentation, Life cycle, Pharmacopoeia, Capsule, Bias, LDPE, Inhalation, Conformity, Publication, The central science, ICH, Orientation, NB, Lubricant, AIM, Excipient, Temperature, Monograph, Humidity, Cold, Light, Life, Medication package insert, Rugosity, Quality, Water, Yesa, Administration, Weight loss, Life insurance

17

Key Points: 
    • 17

      Guideline on the pharmaceutical quality of inhalation and
      nasal medicinal products

      18

      Table of contents

      19

      Executive summary ..................................................................................... 3

      20

      1.

    • Lifecycle management ........................................................................................ 28

      49

      Definitions ................................................................................................. 29

      16

      50
      51

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 2/30

      52

      Executive summary

      53

      This guideline is the first revision of the guideline on pharmaceutical quality of inhalation and nasal

      54

      products (EMEA/CHMP/QWP/49313/2005 Corr).

    • Quality aspects specific to inhalation and nasal medicinal products are discussed, the need for

      66

      safety testing (e.g., for excipients and leachables) is also considered.

    • 69

      Detailed guidance on pharmaceutical development study designs (e.g., priming studies) and the

      70

      analytical procedures primarily used for inhalation and nasal medicinal products (e.g., cascade

      71

      impactor analysis) is not included in this guideline.

    • Scope

      74

      The guideline addresses requirements "on the quality of inhalation and nasal medicinal products" in

      75

      new marketing authorisation applications, including abridged applications.

    • Liquid inhalation anaesthetics and nasal ointments, creams and gels are

      88

      excluded, however the general principles described in this guideline should be considered.

    • 118

      Different polymorphic forms including any amorphous content could affect the quality or performance

      119

      of the finished medicinal product.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 4/30

      132

      The primary packaging, type of inhaler and, if necessary, the secondary packaging or other

      133

      components required for reasons of stability should be described.

    • Pharmaceutical
      development study

      (a) Physical
      characterisation
      (b) Minimum fill
      justification
      (c) Extractable
      volume

      Pressurised

      Dry powder

      Preparations for

      Non-

      metered-

      inhalers (DPI)

      nebulisation

      pressurised

      dose

      metered-

      Device-

      Pre-

      Single-

      Multi-

      (pMDI)

      metered

      metered

      dose

      dose

      inhalers

      Yesa

      Yes

      Yes

      Yesa

      Yesa

      Yesa

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      No

      No

      No

      Yes

      No

      No

      inhalers

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      dose

      Page 5/30

      Table 4.2.1.

    • The last doses delivered by

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 7/30

      179

      the inhaler as defined by the label claim, should meet the finished medicinal product specification limits

      180

      for delivered dose and fine particle dose.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 9/30

      263
      264

      4.2.2.8.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 11/30

      345

      Instructions regarding cold temperature use should be provided in the product information.

    • Finished medicinal
      product

      Pressurised

      Dry powder inhalers

      Preparations for

      metered-

      (DPI)

      nebulisation

      dose

      Nonpressurised
      metered-dose

      Device-

      Pre-

      Single-

      Multi-

      (pMDI)

      metered

      metered

      dose

      dose

      inhalers

      (a) Description

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      (b) Assay

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      (c) Moisture content

      Yes

      Yes

      Yes

      No

      No

      No

      Yes

      Yes

      Yes

      No

      No

      Yes

      Yes

      Yes

      Yes

      No

      No

      Yes

      specification test

      (d) Mean delivered
      dose
      (e) Uniformity of
      delivered dose

      inhalers

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 15/30

      Table 4.2.2.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 16/30

      510

      4.2.5.4.

    • The proposed specification limits should take into account the shelf-life performance of the
      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 17/30

      552

      medicinal product.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 18/30

      586

      All medical devices, including inhalers and nasal devices, have to fulfil the general requirements as

      587

      outlined in the Medical Device Regulation (EU) 2017/745.

    • Stability (CTD 3.2.P.8)

      598

      All inhalation medicinal products should be tested on stability against the stability indicating tests

      599

      included in the finished medicinal product specification.

    • Quality data requirements as

      619

      described in this guideline should be met, supplemented by appropriate comparative quality and

      620

      clinical data with respect to the chosen reference medicinal product.

    • 621

      For inhalation medicinal products comparative in vitro data between the abridged application medicinal

      622

      product and the reference medicinal product must be provided.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 20/30

      670

      Nature and contents of container: The type of the device and its components should be listed.

    • Nasal medicinal products

      695

      Inhalation and nasal medicinal products have many similarities and therefore, most of the

      696

      requirements specified for inhalation medicinal products in section 4 also apply for nasal medicinal

      697

      products.

    • One difference between inhalation and nasal medicinal products is the desired

      698

      particle/droplet size of the finished medicinal product.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 21/30

      704

      5.2.

    • Nasal liquids
      Pharmaceutical
      development
      study

      Pressurised

      Nasal

      metered-

      powders,

      dose nasal

      device-

      spray

      metered

      NonSingledose
      drops

      Multidose
      drops

      Single-

      pressurised

      dose

      multidose

      spray

      metereddose spray

      (a) Physical
      characterisation
      (b) Minimum fill
      justification
      (d) Extractables /
      leachables

      Yesa

      Yes

      Yesa

      Yesa

      Yesa

      Yesa

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      No

      Yes

      Yes

      Yes

      Yes

      Yes

      Yes

      No

      No

      Yes

      Yes

      Yes

      Yes

      No

      No

      No

      Yes

      Yes

      Yes

      No

      No

      Yes

      Yes

      (f) Particle /
      droplet size
      distribution
      (g) Uniformity of
      delivered dose
      through container
      life
      (j) Actuator /
      mouthpiece
      deposition

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 22/30

      Table 5.2.1.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 23/30

      728

      5.2.2.2.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 24/30

      769

      5.2.5.

    • Quality data requirements as described in

      799

      this guideline should be met, supplemented by appropriate comparative quality and clinical data with

      800

      respect to the chosen reference medicinal product.

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 27/30

      849

      5.5.

    • 866

      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 28/30

      867

      Definitions
      Activation:

      The act of setting in motion the delivery device.

    • Delivery device:

      The sum of component(s) of the container closure system responsible for
      delivering the active substance to the respiratory tract (inhalation medicinal
      product) or the nasal and/or pharyngeal region (nasal medicinal product).

    • Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 29/30

      Label claim:

      The amount of active substance (usually on a per actuation basis) declared
      on the label of the medicinal product.

    • Nasal medicinal

      A finished medicinal product (including the delivery device, where

      product:

      applicable) whose intended site of deposition is the nasal and/or pharyngeal
      region.

    • 868
      Guideline on the pharmaceutical quality of inhalation and nasal medicinal products
      EMA/CHMP/20607/2024

      Page 30/30

Isabel Schnabel: From laggard to leader? Closing the euro area's technology gap

Retrieved on: 
Thursday, April 18, 2024
Orbis, NACE, PRT, Premium, Employment, FRA, Economics, ITA, BACH, LVA, European Commission, GTA, ECB, Risk, CEIC, Ageing, Intangibles, Policy, Person, NGEU, TFP, GDP, GRC, NLD, EIA, RHS, Bureau of Economic Analysis, Database, Digital, European Economic Association, Journal, LUX, AUT, JPN, Frontier, Harmful, Trade Data Monitor, Gérard Schivardi, Lost, Attention, Growth, LHS, LTU, RRF, COVID-19, Rubric, Productivity, Bank, Capital, HICP, Social, METI, Total
Key Points: 

Talking to Americans reveals the diversity behind the shared opinion ‘the country is on the wrong track’

Retrieved on: 
Wednesday, April 10, 2024
Friends, ABC, Democracy, Tax, Second, Ipsos, Gender identity, Politics, Michigan State University, Opposite, Public opinion, Ageing

One ABC News/Ipsos survey in November 2023 showed three-quarters of Americans believed the country was on the “wrong track.” Only 23% believed it was headed in the “right direction.” And the survey was not an outlier.

Key Points: 
  • One ABC News/Ipsos survey in November 2023 showed three-quarters of Americans believed the country was on the “wrong track.” Only 23% believed it was headed in the “right direction.” And the survey was not an outlier.
  • Poll after poll shows a sizable majority of the nation’s residents disapprove of its course.
  • Have Americans – long seen as upbeat, can-do optimists – really grown dour about the state of the nation and where it’s headed?

An ‘astonishing finding’


“Do you feel things in the country are generally going in the right direction, or do you feel things have gotten off on the wrong track?” That question or one very much like it is well known to anyone who has glanced at a poll story or studied the data of a survey in the past 50 years.

  • These public opinion surveys, often sponsored by news organizations, seek to understand where the public stands on the key issues of the day.
  • Political parties and candidates often conduct their own surveys with a version of the “right direction/wrong track” question to better understand their constituencies and potential voters.
  • In 2023, we worked with Ipsos to survey more than 5,000 people across the country in all those community types.
  • One of the big ones: In every community we surveyed, at least 70% said the country was on the “wrong track.” And that is an astonishing finding.

Agreement for different reasons

  • The community types we study are radically different from each other.
  • Some are full of people with bachelor’s degrees, while others have few.
  • Some of the communities voted for President Joe Biden by landslide numbers in 2020, while others did the same for Donald Trump.
  • Given those differences, how could they be in such a high level of agreement on the direction of the country?
  • In 2020, Biden won 86% of the vote in big metropolitan Manhattan, and Trump won 60% in aging, rural Chenango.

Opposite views in same answer

  • There may be some value in chronicling Americans’ unhappiness with the state of their country, but as a stand-alone question, “right direction/wrong track” is not very helpful.
  • It turns out that one person’s idea about the country being on the wrong track may be completely the opposite of another person’s version of America’s wrong direction.


Dante Chinni receives funding from the Robert Wood Johnson Foundation for his work on the American Communities Project and is a contributor to the Wall Street Journal. Ari Pinkus receives funding from the Robert Wood Johnson Foundation for the American Communities Project.

Clairmont tells the story of the woman Byron cast aside

Retrieved on: 
Wednesday, April 10, 2024
Grief, Noise, Empathy, Ageing, History, Female, Child, Human, Death, Romantic, Woman, Great, Love, Fever, The Great One, Engineering, Fear

A rebellious, freedom-fighting Romantic poet, Byron’s reputation is the stuff of legend, his legacy assured and revered in the European literary canon.

Key Points: 
  • A rebellious, freedom-fighting Romantic poet, Byron’s reputation is the stuff of legend, his legacy assured and revered in the European literary canon.
  • While the star of Byron’s literary fame rose, however, many fell by the wayside, cruelly discarded by the poet.
  • It was the summer of 1816, dubbed the “year without a summer”“ thanks to a volcanic eruption in Indonesia.
  • She later described it in her author’s introduction to the 1831 edition of her terrifying and groundbreaking novel.

A different perspective

  • Viewed from the perspective of Claire Clairmont – but not narrated by her – the novel imagines and explores the feelings of the person who propelled Shelley and Mary Godwin to accompany her to Lake Geneva so that she could pursue her passion for Byron.
  • She leaves Byron’s bed one morning, intoxicated by the illusion that: "She’s a lover of a Great One.
  • Elsewhere, Byron calls her a handmaiden, making his feelings for her brutally clear by shaming her in front of the other guests.
  • The story is narrated across three different decades of Clairmont’s life, with chapters on the three decades interspersed throughout the novel.

Life after Byron

  • Byron of course looms large, first in his attempts to end Clairmont’s pregnancy, and then in his insistence that their daughter, Allegra, live with him, only then to send her away to school.
  • The novel also portrays the absence of empathy between Godwin and Clairmont throughout their lives, by drawing from correspondence and journal entries.
  • Byron and Shelley both died young, and in middle age, the mutual suspicion between the two surviving women persists.
  • It explores the painful sacrifice and erasure of female suffering at the altar of more “heroic” male narratives of love, idealism and creation.


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Angela Wright 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.