Wolfgang Reinert - Guidance on guidance document development
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This document outlines a proposed guidance on developing guidance documents. It would define the process for creating and revising guidance documents, including establishing competencies, drafting steps, adoption procedures, and application dates. The guidance aims to improve quality, usefulness, and transparency by clarifying roles, avoiding duplication, and communicating the process to authorities and stakeholders. A stepwise approach is recommended that identifies needs, produces concept papers, allows for discussion and adoption, and publishes the final documents.
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DOCUMENT
A DOCUMENT is a piece of written, printed, or electronic matter that provides information or evidence or that serves as an official record.
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PURPOSE OF DOCUMENTATION:
Defines specifications and procedures for all materials and methods of manufacture and control.
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Drug substance :
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Drug product :
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GOAL
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To find out more visit: http://mneguidelines.oecd.org/responsible-mineral-supply-chains-audits.htmICH.pdf
The document discusses the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It summarizes that ICH is unique in bringing together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of drug registration and develop harmonized guidelines. ICH aims to harmonize technical requirements for pharmaceutical registration globally to help ensure safe, effective and high-quality medicines are developed and registered efficiently. It outlines ICH's structure and processes for developing guidelines through working groups and regulatory and industry members.
ICH.ppt
ICH Q8, Q9, and Q10 guidelines provide a risk-based and scientific approach to pharmaceutical development and manufacturing. Q8 describes pharmaceutical development and quality by design. Q9 covers quality risk management principles. Q10 addresses pharmaceutical quality systems. The guidelines work together throughout the product lifecycle from development to commercial manufacturing and continual improvement. Their integrated implementation enhances product quality and manufacturing efficiency.
02_Q8_9_10_together.ppt
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Ich ppt
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Title is self explanatory
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A DOCUMENT is a piece of written, printed, or electronic matter that provides information or evidence or that serves as an official record.
WHY DOCUMENTATION
Documents and products are produced in pharmaceuticals but regulatory bodies are interested to see documents first.
Due to the importance given to documentation in pharma "good documentation practices" is required.
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PURPOSE OF DOCUMENTATION:
Defines specifications and procedures for all materials and methods of manufacture and control.
Ensures that all personnel knows what to do and when to do it.
Ensure that authorized persons have all information necessary for release of product.
Ensures documented evidence, traceability, provide records and audit trail for investigation.
Ensures availability of data for validation, review and statistical analysis.
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Drug substance is an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.
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Many companies today utilize some form of a traditional phased-and-gated product development process, which originated more than 50 years ago. It hasn’t changed substantially since then.
A phased-and-gated system creates multiple batches that slows down the overall speed of a product development project.
When companies try to maintain a traditional phased- and-gated process in a changing environment, the product development team is unable to manage to the scope, timeline and budget approved at the outset.
The result usually includes changing product requirements, unexpected problems, rework, schedule delays, breaking the budget and commercial failure.
GOAL
Develop Exploratory PD® (ExPD), which help companies achieve growth and improve product development success through an adaptive system.
The primary goal of ExPD is to reduce uncertainty and risk by reducing the unknown.
When organizations adapt quickly to the changing environment (market, technology, regulations, globalization, etc.), they reduce uncertainty and risk leading to product success.
APPROACH
The product development team needs an approach that allows them to adapt to change in customer needs, markets, competition, technology and more.
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To find out more visit: http://mneguidelines.oecd.org/responsible-mineral-supply-chains-audits.htmICH.pdf
The document discusses the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It summarizes that ICH is unique in bringing together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of drug registration and develop harmonized guidelines. ICH aims to harmonize technical requirements for pharmaceutical registration globally to help ensure safe, effective and high-quality medicines are developed and registered efficiently. It outlines ICH's structure and processes for developing guidelines through working groups and regulatory and industry members.
ICH.ppt
ICH Q8, Q9, and Q10 guidelines provide a risk-based and scientific approach to pharmaceutical development and manufacturing. Q8 describes pharmaceutical development and quality by design. Q9 covers quality risk management principles. Q10 addresses pharmaceutical quality systems. The guidelines work together throughout the product lifecycle from development to commercial manufacturing and continual improvement. Their integrated implementation enhances product quality and manufacturing efficiency.
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ICH Q8, Q9, and Q10 guidelines provide a risk-based and scientific approach to pharmaceutical development and manufacturing. Q8 describes pharmaceutical development and quality by design. Q9 covers quality risk management principles. Q10 addresses pharmaceutical quality systems. The guidelines work together throughout the product lifecycle from development to commercial manufacturing and continual improvement. Their integrated implementation enhances product quality and manufacturing efficiency.
Ich ppt
The document discusses the International Council for Harmonisation (ICH), an international body that aims to harmonize technical requirements for pharmaceutical product registration among regulators in Europe, Japan, and the United States. The ICH seeks to reduce duplication of clinical trials, accelerate drug development and licensing, and make safe and effective therapies more widely available. It has produced over 50 harmonized guidelines covering quality, safety, efficacy, and multidisciplinary topics to standardize pharmaceutical development and evaluation globally.
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1) The document outlines EFSA's work on developing guidance documents for estimating soil degradation rates, soil exposure concentrations, emissions from protected crop systems, and groundwater exposure assessments.
2) EFSA has published opinions and supporting documents on estimating soil degradation rates and soil exposure and is developing guidance documents on these topics for 2013-2014.
3) EFSA is also developing a new guidance document on estimating emissions from protected crop systems based on published opinions and reports, with the guidance foreseen for 2013.
4) EFSA received mandates from the European Commission for two opinions on the FOCUS groundwater report to evaluate lower and higher tier assessment recommendations, with opinions planned for adoption in 2013.
Luc Mohimont - Probabilistic risk assessment
The document discusses the PPR Panel guidance on using probabilistic methodology to model dietary exposure to pesticide residues. It will provide guidance on how cumulative exposure varies across populations for acute and chronic exposure scenarios. It details basic and refined probabilistic modeling approaches and notes the guidance will be adopted in June 2012 after two public consultations. Next steps include EFSA developing more detailed guidance documents on specific scenarios in cooperation with the Commission and Member States.
Istvan Sebestyen - Cumulative risk-assessment
This document discusses the Panel on Plant Protection Products' (PPR Panel) work on cumulative risk assessment of pesticides. It outlines the legislative background requiring consideration of cumulative and synergistic effects of pesticides. It describes the PPR Panel's past scientific opinions developing methodologies for cumulative assessment of pesticides with similar and dissimilar modes of action. It also lists current and planned activities, including developing guidance on probabilistic exposure modeling and identifying cumulative assessment groups of pesticides. Finally, it discusses emerging work on assessing cumulative exposure from non-dietary routes.
Hans Steinkellner - Metabolites for dietary risk assessment
The document discusses tools for assessing the toxicological relevance of pesticide metabolites for dietary risk assessment. It summarizes several EFSA projects evaluating the applicability of thresholds of toxicological concern, quantitative structure-activity relationships, and the impact of metabolism on toxicity for this purpose. The projects concluded that thresholds of toxicological concern are appropriate for assessing metabolite risk and that combinations of models may help determine genotoxicity. A draft scientific opinion will apply these tools in case studies and address uncertainties to derive acute and chronic exposure thresholds for metabolites.
Istvan Sebestyen - Workers operators bystanders and residents
The document provides background on EFSA's efforts to develop guidance on pesticide exposure assessment. It summarizes EFSA's process of gathering input, conducting public consultations, and drafting the guidance document and related scientific opinion between 2006-2010. The main contents of the scientific opinion are outlined, including defining the scope, reviewing legal requirements, current risk assessment methods, and proposed new approaches for assessing acute risk and accounting for statistical variability.
Luc Mohimont - Priorities of the PPR panel
The PPR Panel is responsible for providing EFSA's scientific opinions on pesticides. Composed of 21 members with a 3-year renewable mandate, it is supported by working groups of external experts. The PPR Panel adopts scientific opinions, guidance documents, and statements on areas like human and environmental risk assessment of pesticides. It has adopted 58 opinions since 2004, including 41 on generic issues and guidance and 17 on specific compounds. Guidance development will increasingly be handled by EFSA working groups including PPR Panel experts. The PPR Panel has ongoing mandates through 2017 on topics like aquatic ecotoxicology and terrestrial ecotoxicology.
Aija Kazocina - Update on risk assessment of MRLs
The document provides an update on EFSA's progress in assessing maximum pesticide residue limits (MRLs) according to Articles 10 and 12 of Regulation (EC) No 396/2005. [1] EFSA is responsible for assessing new MRL proposals under Article 10 and reviewing existing MRLs under Article 12 to ensure they are safe for consumers. [2] From 2008-2012, EFSA assessed 432 new MRL applications under Article 10 and is ongoing in its review of existing MRLs for 167 substances approved before 2008 and 243 approved after under Article 12. [3] The document notes some priorities and challenges for applicants in the MRL assessment process.
Daniela Brocca - Pesticide residues in food: Monitoring programmes in Europe ...
The document summarizes monitoring programs and findings related to pesticide residues in food in Europe. It discusses the legal framework for monitoring in EU countries, EFSA's annual reports on pesticide residues, and a new EU data collection system. The main findings from EFSA's 2009 annual report are that over 97% of samples did not exceed maximum residue levels, with exceedances more common in imported and unprocessed foods. EFSA also conducts cumulative risk assessments of pesticide residues.
IBMA input and EFSA/PSC response at industry meeting April 2012
The document summarizes discussions between EFSA and IBMA on various topics related to the review of List 4 biocontrol substances. Key points included an update from EFSA on timelines for reviews, acknowledgment of the value of a post-assessment lessons learned document, and discussions around guidance documents, data requirements and waivers, consequences of delays, and handling of substances included in the Green Track process. EFSA advised that many of the issues raised would need to be addressed by risk managers or relevant expert groups.
Herman Fontier - Update on the evaluation of active substances
This document summarizes Herman Fontier's presentation on the evaluation of active substances by the European Food Safety Authority (EFSA). The presentation discusses EFSA's peer review activities in 2011, including conclusions delivered. It also outlines the peer review planning for 2012 and beyond, implementation of Regulation (EC) No 1107/2009, and the process for commenting on draft EFSA conclusions.
Per Bergman - EFSA general priorities
EFSA provides independent scientific advice on food safety and nutrition issues to the European Commission, European Parliament, and EU member states. In 2013, EFSA predicted 676 scientific outputs to meet the continuing high demand for scientific advice. Key priorities included boosting risk assessment capacity, enhancing dialogue with risk managers, and improving efficiency. Major science highlights included providing scientific opinions on meat inspection modernization, dietary reference values, and assessments of genetically modified organisms, pesticides, and food contact materials.
J.P Busnardo - ECPA industry feedback
1) The document provides industry's view on EFSA's contributions to pesticide regulation, including their processes for active substance peer reviews, establishing maximum residue levels (MRLs), and scientific guidance.
2) While timelines are generally respected, industry finds some EFSA comments on active substance evaluations arrive too late and there are limitations on submitting new information.
3) Guidelines for MRL reasoned opinions are followed predictably but outcomes are sometimes viewed as conservative.
4) The annual MRL report is considered very useful but guidance documents are seen as sometimes disconnected from use contexts and imposing unnecessarily complex or conservative standards.
Jeff Pim - Botanicals
The document discusses several issues related to evaluating the safety of botanical active substances for use in plant protection products and biocides. It notes limited toxicology data available for many botanicals due to a lack of standardized testing methods. It also raises questions around defining the identity of active substances in botanicals and ensuring representative marker compounds are used in required studies.
Hungry for Change - Mella Frewen
This document discusses sustainability in the EU food and drink industry. It notes that the industry purchases 70% of EU agricultural produce and is the largest agricultural importer globally, relying on stable supplies of high quality raw materials. It highlights challenges like climate change, population growth, and resource scarcity putting pressure on food security. The document advocates for reducing waste, promoting industrial symbiosis, and cooperation across the food chain to develop sustainable solutions through roundtable discussions. It stresses the importance of securing raw materials sustainably to support the EU economy and food supply.
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- 1. Guidance on guidance document development Wolfgang Reinert European Commission Health and Consumers Directorate General Unit Chemicals, contaminants, pesticides ECPA-IBMA workshop – EFSA evaluation of PPP 26 April 2012 Health and Consumers
- 2. Guidance document on guidance documents What ? • Provide procedure for producing new and revising existing GDs • Define - competencies - steps to be followed in drafting - adoption procedure - adoption date • Include a (continuously updated) list of guidance documents Health and Consumers
- 3. Guidance document on guidance documents Why ? • Acknowledge different roles of different players • Avoid duplication of work • Improve quality and usefulness of the GDs • Improve communication and create transparency (Authorities, stakeholders, Third Countries) Health and Consumers
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