Factorization of polynomials

Draft guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin - Revision 1

Retrieved on: 
Thursday, April 18, 2024

REFERENCES ....................................................................................................................................... 14

Key Points: 
    • REFERENCES ....................................................................................................................................... 14

      29

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 3/14

      30

      EXECUTIVE SUMMARY

      31
      32
      33
      34
      35
      36

      This guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin

      37

      1.

    • Due to the inherent
      complexity of medicinal plants and herbal substances the quality of these starting materials requires an
      adequate quality assurance system for the collection and/or cultivation, harvest, and primary
      processing.
    • (either outdoor, indoor or in greenhouses) should be carefully considered, since each of the mentioned
      types could have several problems and advantages.
    • The used cultivation method may be dependent on
      the final application of the herbal medicinal product.
    • primary processing of herbal substances that are used for the preparation of herbal medicinal products.
    • medicinal plants and herbal substances, ensuring that they are handled appropriately throughout all
      stages of cultivation, collection, processing and storage.
    • their preparations are exposed to a large number of environmental contaminants of both biotic and
      abiotic origin.
    • to existing wildlife habitats and must adhere to CITES (Convention on International Trade in
      Endangered species of Wild Fauna and Flora).
    • https://health.ec.europa.eu/document/download/bd537ccf-9271-4230-bca1-2d...
      4 https://health.ec.europa.eu/document/download/fd318dd6-2404-4e67-82b0232...
      3

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 5/14

      104

      4.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

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      147
      148
      149

      8.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 7/14

      185

      7.

    • Where possible, stable varieties and cultivars naturally
      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 8/14

      227
      228

      resistant or tolerant to disease should preferably be used.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 9/14

      268
      269
      270
      271
      272
      273

      The application should be carried out only by qualified staff using approved equipment.

    • The following should be noted:

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 10/14

      309
      310

      ?

      311
      312
      313

      ?

      314
      315
      316
      317

      ?

      318
      319
      320

      ?

      321
      322

      ?

      323
      324
      325

      ?

      326
      327
      328

      ?

      Damaged plants or plant parts need to be excluded or limited in accordance with a specific
      pharmacopoeia monograph, where relevant.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 11/14

      347
      348

      directly to the sun (except in cases where there is a specific need) and must be protected from
      rainfall, insect infestation, etc.

    • The label must be clear, permanently fixed and made from

      6

      Reflection paper on the use of fumigants (EMEA/HMPC/125562/2006)

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 12/14

      386
      387

      non-toxic material.

    • Certain exudates that have not been subjected to a specific treatment are

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 13/14

      425
      426
      427

      also considered to be herbal substances.

    • European Pharmacopoeia General Monograph ?HERBAL DRUGS? 07/2017:1433

      Are obtained by subjecting herbal substances to treatments such as
      extraction, distillation, expression, fractionation, purification, concentration
      or fermentation.

Draft guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin - Revision 1

Retrieved on: 
Thursday, April 18, 2024

REFERENCES ....................................................................................................................................... 14

Key Points: 
    • REFERENCES ....................................................................................................................................... 14

      29

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 3/14

      30

      EXECUTIVE SUMMARY

      31
      32
      33
      34
      35
      36

      This guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin

      37

      1.

    • Due to the inherent
      complexity of medicinal plants and herbal substances the quality of these starting materials requires an
      adequate quality assurance system for the collection and/or cultivation, harvest, and primary
      processing.
    • (either outdoor, indoor or in greenhouses) should be carefully considered, since each of the mentioned
      types could have several problems and advantages.
    • The used cultivation method may be dependent on
      the final application of the herbal medicinal product.
    • primary processing of herbal substances that are used for the preparation of herbal medicinal products.
    • medicinal plants and herbal substances, ensuring that they are handled appropriately throughout all
      stages of cultivation, collection, processing and storage.
    • their preparations are exposed to a large number of environmental contaminants of both biotic and
      abiotic origin.
    • to existing wildlife habitats and must adhere to CITES (Convention on International Trade in
      Endangered species of Wild Fauna and Flora).
    • https://health.ec.europa.eu/document/download/bd537ccf-9271-4230-bca1-2d...
      4 https://health.ec.europa.eu/document/download/fd318dd6-2404-4e67-82b0232...
      3

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 5/14

      104

      4.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 6/14

      147
      148
      149

      8.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 7/14

      185

      7.

    • Where possible, stable varieties and cultivars naturally
      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 8/14

      227
      228

      resistant or tolerant to disease should preferably be used.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 9/14

      268
      269
      270
      271
      272
      273

      The application should be carried out only by qualified staff using approved equipment.

    • The following should be noted:

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 10/14

      309
      310

      ?

      311
      312
      313

      ?

      314
      315
      316
      317

      ?

      318
      319
      320

      ?

      321
      322

      ?

      323
      324
      325

      ?

      326
      327
      328

      ?

      Damaged plants or plant parts need to be excluded or limited in accordance with a specific
      pharmacopoeia monograph, where relevant.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 11/14

      347
      348

      directly to the sun (except in cases where there is a specific need) and must be protected from
      rainfall, insect infestation, etc.

    • The label must be clear, permanently fixed and made from

      6

      Reflection paper on the use of fumigants (EMEA/HMPC/125562/2006)

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 12/14

      386
      387

      non-toxic material.

    • Certain exudates that have not been subjected to a specific treatment are

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 13/14

      425
      426
      427

      also considered to be herbal substances.

    • European Pharmacopoeia General Monograph ?HERBAL DRUGS? 07/2017:1433

      Are obtained by subjecting herbal substances to treatments such as
      extraction, distillation, expression, fractionation, purification, concentration
      or fermentation.

Shifts in how sex and gender identity are defined may alter human rights protections: Canadians deserve to know how and why

Retrieved on: 
Wednesday, April 10, 2024

Recent education policy changes and protests about sex education reveal increasing concern and polarization over how sex and gender identity are taught in public schools in Canada.

Key Points: 
  • Recent education policy changes and protests about sex education reveal increasing concern and polarization over how sex and gender identity are taught in public schools in Canada.
  • They also expose the significant role now played by school boards in constructing the meaning of gender identity and gender expression.
  • Changes in how words and terms are used can impact our ability to know about people’s lives and protect their rights.
  • Significant shifts are taking place around how we define and understand sex and gender in education and public policy in Canada.

Sex, gender and law

  • Yet sex, gender identity and gender expression are not defined in human rights legislation in Canada.
  • They should be able to express their concerns and participate in open discussions about the meaning of words we share.

Changes in the definition of sex

  • The Charter of the United Nations prohibits sex discrimination.
  • The United Nations Universal Declaration of Human Rights precludes discrimination based on sex.

Changes since 2018


Since 2018, the word sex is increasingly defined by the federal government as something that is “assigned at birth.” But there is no consistency across federal departments and agencies. Some continue to define sex as a biological question of male or female. Those that define sex as assigned at birth do not consistently explain how sex is assigned or by whom.

Conceptual shifts around word ‘woman’

  • Similar conceptual shifts are taking place around the word woman.
  • The word woman was formerly linked to sex and used to refer to female people.
  • Now, government departments including the Department of Justice increasingly use the word woman to refer to all people who identify as women.

Defining gender identity

  • When gender identity was added to federal human rights legislation, the Department of Justice defined gender identity as:
    “each person’s internal and individual experience of gender.
  • A person’s gender identity may or may not align with the gender typically associated with their sex.”
    “A person’s internal and deeply felt sense of being a man or woman, both or neither.
  • A person’s gender identity may or may not align with the gender typically associated with their sex.”

School boards define terms differently

  • Researchers have identified that secular boards across Ontario define gender identity and gender expression differently from one another.
  • Some school boards now define gender identity as something everyone has.

Data collection shifts away from sex towards gender

  • A shift away from sex and towards gender (identity) has occurred in data collection practices at the federal government level.
  • In 2018, the Treasury Board of Canada Secretariat and the Department of Justice Canada recommended “ways to modernize how the Government of Canada handles information on sex and gender.” They recommended that “departments and agencies should collect or display gender information by default, unless sex information is specifically needed.” They used “sex” to refer to biological characteristics, and “gender” to refer to a social and personal identity.

Open discussions are overdue


As Canadian society shifts to accommodate the legal recognition of gender diversity, there will be tensions. Ultimately, courts will be tasked with deciding how some of those tensions are resolved, when sex, gender identity and gender expression are all protected in human rights laws. In the meantime, as a society, we need to openly and transparently grapple with some increasingly important questions:
First, how will foundational concepts such as sex, gender identity and gender expression be defined and given effect in education, law, public policy and beyond?
Second, how will tensions between experiences, interests and rights associated with sex and those associated with gender identity and/or gender expression be resolved?
Third, who is best placed to decide how these questions are answered in education, law, public policy and beyond?
Everyone who may be impacted by the answers to these questions should be included in the conversation.
Debra M Haak receives funding from the Social Sciences and Humanities Research Council, the Canadian Bar Association Law for the Future Fund, and the Queen's University Faculty Association Fund for Scholarly Research.

Charles River to Perform Plasmid Production for Ship of Theseus

Retrieved on: 
Thursday, April 4, 2024

Charles River Laboratories International, Inc. (NYSE: CRL) and Ship of Theseus , a therapeutics company developing degradation-resistant homeobox (HOX) family biologics, today announced a Good Manufacturing Practice- (GMP) plasmid DNA contract development and manufacturing organization (CDMO) agreement.

Key Points: 
  • Charles River Laboratories International, Inc. (NYSE: CRL) and Ship of Theseus , a therapeutics company developing degradation-resistant homeobox (HOX) family biologics, today announced a Good Manufacturing Practice- (GMP) plasmid DNA contract development and manufacturing organization (CDMO) agreement.
  • Ship of Theseus will leverage Charles River’s premier expertise to manufacture GMP plasmid DNA to serve as the active drug substance for its lead candidate.
  • Charles River’s GMP plasmid DNA CDMO center of excellence based in Keele, United Kingdom will lead the collaboration, providing services that include plasmid DNA backbone generation, plasmid synthesis, GMP master cell bank (MCB) generation, pre-production evaluation, and GMP plasmid DNA manufacture including in-house release testing.
  • We trust the team’s decades of success developing, producing, and reliably delivering plasmid DNA and look forward to bringing our therapies to patients.” – Jeremy Elser, Founding CEO, Ship of Theseus

Charles River to Perform Plasmid Production for Ship of Theseus

Retrieved on: 
Thursday, April 4, 2024

Charles River Laboratories International, Inc. (NYSE: CRL) and Ship of Theseus , a therapeutics company developing degradation-resistant homeobox (HOX) family biologics, today announced a Good Manufacturing Practice- (GMP) plasmid DNA contract development and manufacturing organization (CDMO) agreement.

Key Points: 
  • Charles River Laboratories International, Inc. (NYSE: CRL) and Ship of Theseus , a therapeutics company developing degradation-resistant homeobox (HOX) family biologics, today announced a Good Manufacturing Practice- (GMP) plasmid DNA contract development and manufacturing organization (CDMO) agreement.
  • Ship of Theseus will leverage Charles River’s premier expertise to manufacture GMP plasmid DNA to serve as the active drug substance for its lead candidate.
  • Charles River’s GMP plasmid DNA CDMO center of excellence based in Keele, United Kingdom will lead the collaboration, providing services that include plasmid DNA backbone generation, plasmid synthesis, GMP master cell bank (MCB) generation, pre-production evaluation, and GMP plasmid DNA manufacture including in-house release testing.
  • We trust the team’s decades of success developing, producing, and reliably delivering plasmid DNA and look forward to bringing our therapies to patients.” – Jeremy Elser, Founding CEO, Ship of Theseus

Premier Pediatric Research Center Adopts Complion's eISF Platform to Strengthen Pediatric Research Excellence

Retrieved on: 
Tuesday, March 26, 2024

This collaboration marks a significant milestone, as another of the nation's top 10 pediatric research institutions has chosen Complion's sophisticated eISF system to improve compliance and data management processes across its research endeavors.

Key Points: 
  • This collaboration marks a significant milestone, as another of the nation's top 10 pediatric research institutions has chosen Complion's sophisticated eISF system to improve compliance and data management processes across its research endeavors.
  • As a leading pediatric medical center overseeing almost 150 ongoing studies across its research portfolios, this world-class institution sought an exceptional eClinical solution to meet the demands of its complex pediatric clinical research.
  • Complion was chosen because of its ability to simplify research workflows by converting manual, time-consuming tasks into automated, efficient operations.
  • Complion's eISF system is distinguished by its targeted design, developed to meet the unique requirements of complex pediatric clinical research.

Novo Holdings Joins €30M Series A Financing for Asgard Therapeutics, Leader In In Vivo Cell Reprogramming To Treat Cancer

Retrieved on: 
Thursday, March 14, 2024

The financing was co-led by RV Invest and Johnson & Johnson Innovation – JJDC, Inc. – with participation from existing investors Novo Holdings, Boehringer Ingelheim Venture Fund and Industrifonden.

Key Points: 
  • The financing was co-led by RV Invest and Johnson & Johnson Innovation – JJDC, Inc. – with participation from existing investors Novo Holdings, Boehringer Ingelheim Venture Fund and Industrifonden.
  • Asgard Therapeutics' approach enables the transformation of cancer cells into immune cells to induce a broad immune response specific to the patient's own tumors.
  • The approach uses direct cell reprogramming to transform tumor cells into a sub-type of dendritic cell which present tumor antigens to the immune system.
  • "Asgard promises to leapfrog a core challenge in immuno-oncology – the heterogeneity of solid tumors – through the first pan-tumoral cell reprogramming approach.

Asgard Therapeutics announces €30 million Series A financing to advance its first-in-class in vivo cell reprogramming platform for immuno-oncology

Retrieved on: 
Thursday, March 14, 2024

The round was co-led by RV Invest and Johnson & Johnson Innovation – JJDC, Inc., with participation from existing investors Novo Holdings, Boehringer Ingelheim Venture Fund and Industrifonden.

Key Points: 
  • The round was co-led by RV Invest and Johnson & Johnson Innovation – JJDC, Inc., with participation from existing investors Novo Holdings, Boehringer Ingelheim Venture Fund and Industrifonden.
  • AT-108 is a first-in-class, off-the-shelf gene therapy that directly reprograms tumor cells into antigen-presenting dendritic cells, ultimately leading to a personalized anti-tumor immune response.
  • João Ribas, Principal, Novo Holdings, Seed Investments, said: "We're thrilled to welcome new investors JJDC and RV Invest to Asgard Therapeutics.
  • This marks a significant milestone for Asgard's novel concept of direct in vivo cellular reprogramming in oncology.

Novo Holdings Joins €30M Series A Financing for Asgard Therapeutics, Leader In In Vivo Cell Reprogramming To Treat Cancer

Retrieved on: 
Thursday, March 14, 2024

The financing was co-led by RV Invest and Johnson & Johnson Innovation – JJDC, Inc. – with participation from existing investors Novo Holdings, Boehringer Ingelheim Venture Fund and Industrifonden.

Key Points: 
  • The financing was co-led by RV Invest and Johnson & Johnson Innovation – JJDC, Inc. – with participation from existing investors Novo Holdings, Boehringer Ingelheim Venture Fund and Industrifonden.
  • Asgard Therapeutics' approach enables the transformation of cancer cells into immune cells to induce a broad immune response specific to the patient's own tumors.
  • The approach uses direct cell reprogramming to transform tumor cells into a sub-type of dendritic cell which present tumor antigens to the immune system.
  • "Asgard promises to leapfrog a core challenge in immuno-oncology – the heterogeneity of solid tumors – through the first pan-tumoral cell reprogramming approach.

Asgard Therapeutics announces €30 million Series A financing to advance its first-in-class in vivo cell reprogramming platform for immuno-oncology

Retrieved on: 
Thursday, March 14, 2024

The round was co-led by RV Invest and Johnson & Johnson Innovation – JJDC, Inc., with participation from existing investors Novo Holdings, Boehringer Ingelheim Venture Fund and Industrifonden.

Key Points: 
  • The round was co-led by RV Invest and Johnson & Johnson Innovation – JJDC, Inc., with participation from existing investors Novo Holdings, Boehringer Ingelheim Venture Fund and Industrifonden.
  • AT-108 is a first-in-class, off-the-shelf gene therapy that directly reprograms tumor cells into antigen-presenting dendritic cells, ultimately leading to a personalized anti-tumor immune response.
  • João Ribas, Principal, Novo Holdings, Seed Investments, said: "We're thrilled to welcome new investors JJDC and RV Invest to Asgard Therapeutics.
  • This marks a significant milestone for Asgard's novel concept of direct in vivo cellular reprogramming in oncology.