Orientation | Jotup

Grattan on Friday: Ethnic tensions will complicate the Albanese government’s multicultural policy reform

Retrieved on:

Thursday, April 18, 2024

“In 2024, threats to our way of life have surpassed terrorism as Australia’s principal security concern,” he said.

Key Points:

“In 2024, threats to our way of life have surpassed terrorism as Australia’s principal security concern,” he said.
Tensions, especially in western Sydney, are much elevated because of the Middle East conflict.
And the Wakeley attack came just two days after the Bondi Junction shopping centre stabbings, which killed six people.
While that atrocity did not fall under the definition of “terrorism”, inevitably the two incidents were conflated by an alarmed public.
The challenge for political leaders is not just dealing with the immediate increasing threats to cohesion, but with longer term policy.
Andrew Jakubowicz, emeritus professor of sociology at the University of Technology Sydney, highlights the three separate elements of multiculturalism.

“Settlement policy, which deals with arrival, survival and orientation, and the emergence of bonding within the group and finding employment, housing and education
"Multicultural policy, which ensures that institutions in society identify and respond to needs over the life course and in changing life circumstances, and
"Community Relations policy, which includes building skills in intercultural relations, engagement with the power hierarchies of society and the inclusion of diversity into the fabric of decision-making in society - from politics to education to health to the arts.”

The Albanese government last year commissioned an independent review of the present multicultural framework.
Although the review is not due for release until mid-year, the May budget is likely to see some initiatives.

Michelle Grattan 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

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

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

Retrieved on:

Thursday, April 18, 2024

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

Feedback on the input provided by the European Parliament as part of its resolution on the ECB’s Annual Report 2022

Retrieved on:

Thursday, April 18, 2024

Crypto, European banking union, Governance, Exercise, TARGET, Ciccarelli, Single, Climate, OJ, Ethics, Carbon, ECRB, Parliament, Council, European Systemic Risk Board, European Commission, Paris Agreement, Television, Annual, Letter, Speech, Employment, Social, ESRB, Euro, Prejudice, FSB, AML, ECB, Blog, Risk, ESCB, Committee, NGFS, Policy, Woman, Suggestion, Radio, GDP, Privacy, Weather, Person, Climate change, Communication, Digital, Intelligence, Economic and monetary union, SSM, Bias, Knowledge, Mentorship, EMU, Commission, Economy, Publication, Annual report, Financial Action Task Force, Orientation, Nickel, NPL, European Central Bank, Uncertainty, Financial Stability Board, Conference, NCBS, Treaty, Growth, Financial system, Central bank, European Parliament, Network, Natural Resources, COVID-19, Terrorism, Bank, Female, IMF, Multi-function printer, Recreation, Memorandum, Data, AMLA, Security printing

Beyond managing related risks, the financial sector can also contribute to the transition toward a net-zero economy.

Key Points:

Beyond managing related risks, the financial sector can also contribute to the transition toward a net-zero economy.
Our work aims to enhance data transparency in climate change analysis, while informing monetary policy, financial stability and banking supervision.
The indicators we have developed focus on the euro area financial sector and are built from harmonised granular datasets.

EQS-News: Deutsche Wohnen: Stable Performance in the financial year 2023

Retrieved on:

Wednesday, April 10, 2024

Deutsche Wohnen, Tax, EBT, Environment, Sale, NAV, EPRA, Care, Depreciation, LTV, Orientation

In a challenging environment for the real estate industry, Deutsche Wohnen SE delivered a stable operating performance in the financial year 2023.

Key Points:

In a challenging environment for the real estate industry, Deutsche Wohnen SE delivered a stable operating performance in the financial year 2023.
The Deutsche Wohnen Management Board subjected the nursing care activities to a strategic review.
Going forward, Deutsche Wohnen will be making a clearer distinction in the management system between earnings orientation and liquidity orientation.
Going forward, Deutsche Wohnen will reconcile EBITDA to earnings before taxes (EBT), establishing this as the central measure of earnings.

EQS-News: Supervisory Board of ProCredit Holding AG extends contract of Management Board Chair Hubert Spechtenhauser ahead of schedule by a further year

Retrieved on:

Wednesday, April 10, 2024

Corporation, Risk management, Supervisory board, Trust, ProCredit Holding, Frankfurt, Capital market, Orientation, Landesbank, UniCredit, Management

Frankfurt am Main, 19 March 2024 - The Supervisory Board of ProCredit Holding AG decided today to extend the contract of Management Board Chair Hubert Spechtenhauser ahead of schedule by a further year until end-February 2026.

Key Points:

Frankfurt am Main, 19 March 2024 - The Supervisory Board of ProCredit Holding AG decided today to extend the contract of Management Board Chair Hubert Spechtenhauser ahead of schedule by a further year until end-February 2026.
The Supervisory Board is committed to continuity in the management of the ProCredit group and, with this staffing decision, has reaffirmed its recognition of successful strategic management and the achievement of excellent business results.
"As Chair of the Management Board, Hubert Spechtenhauser has driven the development of the ProCredit group in a convincing manner.
We wish him and the entire Management Board continued success," said Rainer Ottenstein, Chair of the Supervisory Board of ProCredit Holding AG.

GF Securities Announced 2023 Annual Results Adhering to Principal Duties and Business Focus, Promoting the High-quality Development of the Company to a New Stage

Retrieved on:

Wednesday, April 10, 2024

Adhering to principal duties and business focus, striving to improve and strengthen core business

Key Points:

Adhering to principal duties and business focus, striving to improve and strengthen core business
GF Securities has four business segments: investment banking, wealth management, trading, and institution and investment management.
It has obtained full-service license and established a complete business chain with perfect layout and leading strength.
As of the end of 2023, the Company had more than 4,400 securities investment consultants, ranking No.
As of 31 December 2023, the Company has issued a total of 103,184 OTC products with an aggregate amount of approximately RMB2,445.63 billion.

The Board of Directors comments on zCapital’s proposals

Retrieved on:

Wednesday, April 10, 2024

Proxy, Risk, Form, Internet, Mass meeting, Insurance, QR, SMI Expanded, Orientation, Feedback, Security (finance)

Baloise’s Board of Directors encourages shareholders to vote and recommends zCapital’s proposals be rejected.

Key Points:

Baloise’s Board of Directors encourages shareholders to vote and recommends zCapital’s proposals be rejected.
The Board offers the prospect to amend the corresponding provisions of the articles of association at the 2025 General Meeting.
On the 21st of February 2024, asset manager zCapital has submitted proposals to the Board of Directors, according to which the registration and voting rights restriction in the articles of associations is to be lifted.
In preparation for this statement, the Board of Directors has initiated the discussion with shareholders and other stakeholders.

Rio Silver Finalizing Access Agreements for Jorimina Property, Peru

Retrieved on:

Wednesday, April 3, 2024

Department of Ayacucho, National Instrument 43-101, Database, Gold, News, National instrument, Nature, Q3, Orientation, Mining

VANCOUVER, British Columbia, April 03, 2024 (GLOBE NEWSWIRE) -- Rio Silver or the "Company", TSX.V: RYO, is pleased to announce it is finalizing an access agreement with the local community for its 100% owned Jorimina project "Jormaina", Department of Ayacucho, Peru.

Key Points:

VANCOUVER, British Columbia, April 03, 2024 (GLOBE NEWSWIRE) -- Rio Silver or the "Company", TSX.V: RYO, is pleased to announce it is finalizing an access agreement with the local community for its 100% owned Jorimina project "Jormaina", Department of Ayacucho, Peru.
The Main Niñobamba zone is located 7 kilometres to east of Jormina where a significant Au-Ag high sulphidation is present.
Jorimina was recognized by Newmont as having all the necessary elements to be capable of hosting a precious metal epithermal resource.
Rio Silver initially plans to confirm the historic surface results and drill results and to determine the shape and the orientation of the precious metal mineralization.

Calibre’s Valentine Gold Mine Property-Wide Exploration Program Underway With Initial Drill Program Southwest of the Leprechaun Deposit Following Recent Discovery Drilling Including 46 g/t Gold Over 5.3 Metres

Retrieved on:

Wednesday, April 3, 2024

Our initial exploration focuses on prioritizing new regional target identification along with resource expansion in previously drilled areas.

Key Points:

Our initial exploration focuses on prioritizing new regional target identification along with resource expansion in previously drilled areas.
Below the Marathon, Berry and Leprechaun pits the gold system remains open for expansion and we see excellent potential for additional high-grade gold mineralization as supported by drill results including 150.27 g/t Au over 4.3 metres.
This mineralization is trending southwest along the VLSZ toward Frank ( Calibre Reports Positive Drill Results February 6, 2024 news release ).
(NL), Calibre Mining’s Vice President, Geology and Exploration for Canada, and a "Qualified Person" under National Instrument 43-101.