RWE

• Real World Evidence Solutions Market Dynamics:
  Key Market Players of Real World Evidence Solutions Industry:
  Prominent players in the Real-World Evidence Solution market include Iqvia Holdings Inc. (US), Merative(US), Optum Inc. (US), Icon Plc.
• Product Development/Innovation: Detailed insights on upcoming trends, research & development activities, and new software launches in the Real-World Evidence Solution market.
• Market Diversification: Exhaustive information about the software portfolios, growing geographies, recent developments, investments in the Real-World Evidence Solution market.
• Competitive Assessment: In-depth assessment of market shares, growth strategies, product offerings, company evaluation quadrant, and capabilities of leading players in the global real-world evidence solution Market.

• Industry level .................................................................................................. 13

  Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
  EMA/CHMP/58124/2023

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  1.

• A reflection paper
  (RP) on the clinical pharmacology package for oligonucleotides is a prioritised activity in the MWP work

  Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
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  plan, and it is envisaged that something similar may be needed for other emerging treatment
  modalities (e.g., peptides).

• Guideline work led by other working parties
  ?

  Revision of the guideline on the requirements for clinical documentation for orally inhaled
  products (CPMP/EWP/4151/00 Rev.

• Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
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  The planned concept papers (CPs) will formulate problem statements for potential workshops and
  subsequent guidance documents will be informed and enriched by the outcome of discussions of
  workshops to be held in 2024.

• Guideline work led by other working parties and committees
  ?

  Revision of Guidance on the investigation of medicinal products in the term and preterm
  neonate (EMEA/536810/2008).

• There is a need for
  Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
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  new guidance in these areas to ensure these novel approaches meet the required evidentiary
  standards and facilitate their evaluation.

• Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
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  ?

  Revision of Guideline on clinical evaluation of diagnostic agents (CPMP/EWP/1119/98/Rev.

• Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
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  ?

  Provide appropriate support to the EU network for generic and hybrid medicines including
  product-specific requirements.

• Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
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  2.3.

• ?

  Cross disciplinary work with Quality Working Party and other stakeholders on physiologically
  based biopharmaceutics modelling (PBBM).

• Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
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  ?

  In order to support adequate evaluation of all methodology MWP will aim to facilitate an
  increase in presence and visibility in relevant committees of methodological expertise from
  across the EU network such as CHMP, PRAC, PDCO, CMD(h), ETF and CAT.

• Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
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  ?

  Product Specific Bioequivalence Guidelines (PSBGLs) (multiple) in liaison with CMD(h): for
  2024, azacitidine, budesonide (LALA GIT), trametinib, dabrafenib, paliperidone palmitate (3M
  depot) and melatonin have been prioritised as the next in series for drafting.

• Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
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  4.2.

• ?

  Cross disciplinary work with Quality Working Party and other stakeholders on PBBM model
  assessment.

• Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
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  ?

  To deliver an improved access to raw data (e.g.

• ?

  Propose regulatory research priorities for funders in across the activities of Methodology
  Working Party, including in the big data area.

• ?

  Establish key communication points in national competent authorities and build a resource of
  key messages and communication materials on regulation and methodology.

• The timing of workshops may need to be arranged according to the

  Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
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  specific needs of the guidance ? either before the guidance is finalised to gather views and
  expertise; or once it is finalised for training purposes.

• Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
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• The Supreme Court overturned lower court rulings which had struck out Smith’s ambitious claim seeking to establish civil (tort) liability for those emitters’ contributions to climate change.
• With the Supreme Court decision, Smith has won the right to present his full case before the High Court.

The case against the corporate emitters

• Smith argued the activities and effects of the corporate defendants amount to three forms of “tort” or civil wrong: public nuisance, negligence, and a new form of civil wrong described as a “proposed climate system damage tort”.
• Read more:
  Children's climate change case at the European Court of Human Rights: what's at stake?
• The first two causes of action – public nuisance and negligence – have long lineages in the common law.
• A key plank of the corporate emitters’ argument was that the courts “are ill-suited to deal with a systemic problem of this nature with all the complexity entailed”.

The challenges of establishing causation

• Questions of causation and proximity have been stumbling blocks for litigants overseas attempting to bring similar tort claims to Smith’s.
• In this case, the seven corporate emitters are associated with around 30% of total New Zealand emissions.
• The court suggested that there may be scope for adjusting the causation rules to better reflect the nature of modern environmental issues like climate change.

What role for tikanga and where now?

• Recent Supreme Court decisions have accepted and applied tikanga as the “first law of New Zealand” including in relation to environmental protection.
• The Court followed that approach in this case, accepting that crucial aspects of Smith’s case rely on tikanga principles.
• The court pronounced that “addressing and assessing matters of tikanga simply cannot be avoided”.

Vernon Rive has previously received funding from the New Zealand Law Foundation.

• “Vetting the registrational program and design of our clinical studies with the FDA is an important milestone for Helius and meeting the agency’s expectations will give us the most efficient path to delivering PoNS Therapy to stroke patients,” said Dr. Antonella Favit-Van Pelt, Helius’ Chief Medical Officer.
• Across all stroke patients in the database, 69.2% of patients experienced at least a 5-point FGA improvement, which is larger than the 4.2-point minimal detectable change usually seen in stroke patients.
• “One of our chief objectives is to optimize access to PoNS Therapy for stroke patients suffering from gait and balance deficit in North America.
• PoNS received breakthrough designations in both multiple sclerosis and stroke in the United States, potentially benefiting, with a new indication, an estimated 90% of stroke patients who are covered by Medicare.