EudraLex

Questions and answers on the European Union framework for (traditional) herbal medicinal products, including those from a ‘non-European’ tradition

Retrieved on: 
Sunday, March 10, 2024
Well, DER, Fungus, Capsule, TUR, Interest, Animal, Part, Exercise, Database, Viral, Hepatitis, Powder, Collection, Directive, Union, Nutrient, DSM-IV codes, Volume, CTD, Legislation, Literature, Fermentation, Diabetes, Pharmacopoeia, Inhalation, Committee, Monograph, NTA, WEU, DCP, AIDS, See, Mineral, Marketing, Safety, Plant, MRA, Autoimmunity, Directive 2001/83/EC, GMP, Documentation, Seed, Heart failure, Distillation, CHMP, MRP, European Medicines Agency, Guideline, Disorder, Mutual, Convention, State, Tablet, Community, Clinical trial, Rapporteur, European Commission, Woman, Medication package insert, Vitamin, Quality, Authority, GACP, SAWP, Pharmacovigilance, Civil service commission, HMPS, Science, Health, Bibliography, Section 4, Infection, Kampo, Commission, Abbreviation, Pathology, Prescription, Human, Medication, Reproduction, EMA, NCA, Chapter One, EDQM, TAM, European Pharmacopoeia, European Economic Area, Food, Regulation (European Union), COM, TCM, Administration, Mutual recognition, Procedure, Medicine, Herbal, Answer, Q&A, HIV, EudraLex, Cancer, Public, Medicinal plants

1

Key Points: 
    • 1
      Committee on Herbal Medicinal Products (HMPC)

      Questions & Answers on the European Union framework
      for (traditional) herbal medicinal products, including those
      from a ?non-European? tradition

      Table of Content
      1.

    • European Pharmacopoeia

      SAWP

      Scientific Advice Working Party

      SmPC

      Summary of Product Characteristics

      THMP

      Traditional Herbal Medicinal Product

      TUR

      Traditional Use Registration

      WEU

      Well-Established Use

      Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.

    • Terminology of herbal medicinal products (Q&A 1-4)

      Question 1
      What are herbal substances, herbal preparations, and herbal medicinal products?

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Question 4
      Are food supplements regulated under the European Union (EU) pharmaceutical legislation
      for (traditional) herbal medicinal products ((T)HMPs)?
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Regulation of herbal medicinal products in the European Union (Q&A 511)

      Question 5
      Where to find the pharmaceutical legislation and dossier requirements for herbal medicinal
      products (HMPs), including traditional herbal medicinal products (THMPs), in the European
      Union (EU)?

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • These countries have,
      through the EEA agreement, adopted the complete Union acquis on medicinal products and are
      consequently parties to the Union procedures.
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Specific provisions for traditional herbal medicinal products (Q&A 1221)

      Question 12
      Which indications can be granted for traditional herbal medicinal products (THMPs)?

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Nov. 2023
      Answer 17

      Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Question 29
      Does the Committee on Herbal Medicinal Products (HMPC) hold a specific database on
      (registered) authorised (traditional) herbal medicinal products ((T)HMPs)?
    • Discussion with Member States intended to be

      Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.

3-Day Virtual Computer System Validation (CSV) Certification Course: Comprehension of the FDA Regulations Impacting your Systems and Hands-on Practice Writing Validation Documents - ResearchAndMarkets.com

Retrieved on: 
Tuesday, November 14, 2023
Technology, Pharmaceutical, Health, Other Technology, Cloud, ICH, EudraLex, Research, Test, Exercise, Risk, Business, Biotechnology, Tobacco, CSV, FDA, Q&A, Documentation, System, PQ, Computer, Boot camp, Risk assessment, Compliance training, Systems development life cycle, Software, Comprehension, SDLC, GxP, Quality control, COTS, OQ, Boot Camp (software), Medical device, Risk management

The following exercises will be included in the course content and can be completed at each attendee's discretion.

Key Points: 
  • The following exercises will be included in the course content and can be completed at each attendee's discretion.
  • If completed before the end of the Boot Camp, the attendee may ask questions during any Q&A session.
  • If completed after the Boot Camp, the attendee may ask questions via Compliance Trainings and a response will be sent as quickly as possible.
  • The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data.

Digitalization, AI and automation lead pack of advances fueling life sciences industry growth, new CRB report finds

Retrieved on: 
Tuesday, September 26, 2023
Horizon, Gene editing, Consultant, Infection, Research, RNA, Messenger, Science, EudraLex, Patient, Chemical engineering, Walters, Cell, Drug discovery, Quality control, Artificial intelligence, ADC, Ionis Pharmaceuticals, AI, R, CRB, Safety, Automation, Pharmaceutical industry, Medical device, Fine chemical

KANSAS CITY, Mo., Sept. 26, 2023 /PRNewswire/ -- Across the vast global life sciences supply chain, data, digitalization, automation, and artificial intelligence are telling complex and compelling stories about how we move vital vaccines, therapies and cures to patients. Are we ready to listen?

Key Points: 
  • CRB releases its latest Horizons: Life Sciences industry report
    The answer, found in CRB's newest survey-based Horizons: Life Sciences report, is an emphatic "yes" as the industry embraces data analytics, automation and AI technologies to streamline how groundbreaking products scale quickly and efficiently from R&D to commercial production.
  • Underpinning the industry's transformation, the report finds, is its progress along the digital plant maturity model, with companies of all sizes adopting an agility mindset.
  • Digitalization investments, the survey data finds, are driving advances in drug discovery, quality control and regulatory compliance.
  • Gene therapies: Survey data reveals a curious split affecting gene therapy's place in the broader life sciences industry.

QAD and USDM Life Sciences Announce New Cloud Assurance Certification

Retrieved on: 
Tuesday, June 28, 2022
Technology, Medical Devices, FDA, Biotechnology, Health, Health Technology, Engineering, Security, Training, Manufacturing, Software, Retail, Education, Internet, Pharmaceutical, Data Management, Supply Chain Management, Cloud, Review, SDLC, Documentation, FDA, View, Patient, CFR, LinkedIn, DSCP, Computer, European Commission, GMP, QAD Inc., Food, Pinterest, Compliance, ERP, Risk, List, Technology, List of life sciences, EudraLex, QAD, USDM, Instagram, Time, Twitter, Program, CSV, Audit, Medical device, Facebook

QAD Inc. , a leading provider of next-generation manufacturing and supply chain solutions in the cloud, will join the exclusive USDM Life Sciences Cloud Assurance Certification program.

Key Points: 
  • QAD Inc. , a leading provider of next-generation manufacturing and supply chain solutions in the cloud, will join the exclusive USDM Life Sciences Cloud Assurance Certification program.
  • After a formal audit and review of QAD SOPs and SDLC business processes, USDM Life Sciences has also released the QAD Cloud Assurance Report .
  • This third party assessment provides QAD life sciences customers with documented evidence of the rigorous and well-tested development, quality, security, cloud hosting, and training processes and policies supporting Life Sciences GMP requirements.
  • USDM manages continuous cloud compliance for hundreds of life sciences customers, and we understand their reluctance to adopt cloud technologies first-hand, said Kim Hutchings, head of alliances at USDM Life Sciences.

Five Day Online Computer System Validation Professional Certificate Program (September 6-10, 2021)

Retrieved on: 
Thursday, August 26, 2021
Online, OQ, Boot, Engineering validation test, PQ, Immersion, CSV, Software, Documentation, Certification, IQ, Test, Comprehension, FDA, ICH, EudraLex, Cryptocurrency, Risk management, Medicine

DUBLIN, Aug. 26, 2021 /PRNewswire/ -- The "Computer System Validation Boot Camp" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Aug. 26, 2021 /PRNewswire/ -- The "Computer System Validation Boot Camp" training has been added to ResearchAndMarkets.com's offering.
  • A course designed to completely immerse you in computer system validation.
  • This course delivers comprehension of the regulations impacting your systems and hands-on practice writing validation documents.
  • We have designed a computer system validation course that not only meets FDA, ICH, and Eudralex expectations for risk-based validation but also prepares you to implement these practices in your company.

Five Day Online Computer System Validation Professional Certificate Program (September 6-10, 2021) - ResearchAndMarkets.com

Retrieved on: 
Wednesday, August 4, 2021
Entertainment, Education, Technology, Other Technology, Online, Training, Pharmaceutical industry, Validity, Quality, Health sciences, Clinical data management, Clinical research, Validation, Health, Life sciences, Verification and validation

The "Computer System Validation Boot Camp" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Computer System Validation Boot Camp" training has been added to ResearchAndMarkets.com's offering.
  • A course designed to completely immerse you in computer system validation.
  • This course delivers comprehension of the regulations impacting your systems and hands-on practice writing validation documents.
  • We have designed a computer system validation course that not only meets FDA, ICH, and Eudralex expectations for risk-based validation but also prepares you to implement these practices in your company.

Working Through Veterinary Drug Development in the EU and USA: 4-Day Course (London, United Kingdom - June 8-11, 2020) - ResearchAndMarkets.com

Retrieved on: 
Monday, March 9, 2020
Veterinary, Health, Pharmaceutical industry, Health, Articles, Life sciences, Pharmaceuticals policy, Marketing authorization, Pharmacology, Medication, Drug development, Clinical trials, European Medicines Agency, EudraLex

The "Working Through Veterinary Drug Development in the EU and USA" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Working Through Veterinary Drug Development in the EU and USA" conference has been added to ResearchAndMarkets.com's offering.
  • This intensive four-day course provides a thorough understanding of how to develop veterinary medicine in the EU and USA.
  • It will take participants through all the stages in the development of a veterinary medicinal product for which marketing authorisation is sought in the EU and the USA.
  • Presentations will cover pharmaceutical and process development, toxicological, pharmacological, residues and environmental studies, safety risk assessments, clinical development, regulatory and marketing input and project management.