Oracle Argus Safety is an advanced and comprehensive adverse events (AE) management system that helps life sciences companies enable regulatory compliance, drive product stewardship, and integrate safety and risk management into one comprehensive platform. Writing a detailed medically oriented description of the events in the form of safety narrative.
Today’s pharmaceutical industry faces many challenges as drug development costs continue to climb, pricing pressures mount, and new global markets gain critical importance. Too often, life science companies view clinical trial information management as a discrete activity, and have not advanced a holistic view of information and content management as enterprise-wide processes. In order to best compete in the global market, life science companies must maximize and leverage clinical information across all operations, including R&D, submissions, labeling and marketing.
While document management technologies have been around for many years, their limitations are far more significant in life sciences than in most other industries. What is needed is a more transformative structured content management platform, which works in harmony with a document management system if not outright replaces it.
Considering that development of just one drug generates thousands of documents comprising millions of pages, it behooves a company to leverage their accumulated data and extract the value from past content exercises. In this study, component reuse across pre-clinical and clinical study content was analyzed at a global pharmaceutical company(4).
Many types of information, such as Study Objective, have a lifecycle well beyond a simple link to one or two documents. Illustrating the workflow of reused clinical data components in drug development documents. This image is a document map showing the relationships between the Toxicology Protocol and Toxicology Report. By leveraging company content, as an example, submission documents could be quickly built on-demand from a searchable library of core data components.
The workflow and process study proved how information reuse in a structured content management system could cut costs, improve accuracy, and get products to market more quickly. Life science companies are increasingly tying structured content management into other systems, such as regulatory management systems. In conclusion, life science companies should consider these new technology approaches to managing clinical content. The ICH Steering Committee (SC) will meet in Fukuoka, Japan from 6 to 11 June to discuss ongoing harmonisation activities. The IPEC Federation (International Pharmaceutical Excipients Council) has published a three-page position paper concerning the risk-based approach of the EU Guidelines following the principles of Quality Risk Management according to ICH Q9. For many years now, discussions have been ongoing as to whether it is possible to include non-distillation technologies as a method for the production of Water for Injections (WFI). The currently valid version of the EU GMP Guide  Annex 15 “Qualification and Validation” from 2001 will finally be replaced by 1 October 2015.
With this GMP MANUAL UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations.
In a highly acclaimed talk held during our GMP Symposium, Richard Denk elucidated the risk factors for contamination and the influence of highly active substances. The European Medicines Agency (EMA) has released a Concept Paper on the Revision of Annex 1 of the Guidelines on Good Manufacturing Practice – Manufacture of Sterile Medicinal Products which addresses the need to update Annex 1 of the European GMP Guide. New versions of Chapter 3 (Premises and Equipment) and Chapter 5 (Production) have been published providing transitional arrangements for toxicological evaluation. FDA Center for Drug Evaluation and Research (CDER) launched an Office of Pharmaceutical Quality (OPQ) as part of its ongoing Quality Initiative.
The ICH Q3D Guideline on Elemental Impurities reached Step 4 of the ICH Process in December 2014 and now enters the implementation period (Step 5). The US Food and Drug Administration (FDA) has just released a list of all new and revised draft guidances it plans to release in 2015. The ICH Steering Committee (SC) and its Expert Working Groups (EWGs) met in Lisbon, Portugal on November 8–13, 2014. Before the end of the year the European Commission has published the “Commission Delegated Regulation (EU) No.
The EMA has published the final version of the „Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities”.
A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorised original biological medicinal product (reference medicinal product) in the EEA.
Officials of Australia and New Zealand have confirmed the plan to stop the development of the joint regulatory authority ANZTPA.
This month representatives of the FDA have met with their cross-agency team from the EMA, the European Commission and GMP experts form European Union Member States in London, in order to make progress on mutual reliance on GMP inspections. ISPE released its Drug Shortages Prevention Plan during the 2014 Annual Meeting in Las Vegas, Nevada. This month the EMA released a “Reflection paper in the requirements for selection and justification of starting materials for the manufacture of chemical active substances”.
On 21 October 2014, the FDA released the final version of its Guidance for Industry entitled „Circumstances that constitute delaying, limiting, or refusing a drug inspection”.

The ICH Steering Committee has endorsed the final concept paper Q12 “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management”.
The use of products with non-declared pharmacological activity or “other illegal medicines”, often from uncontrolled sources but also purchased from the legal market, is still a major problem within Europe. From 10-11 September 2014, the second symposium on combating counterfeits and other illegal medicines took place at EDQM. The Active Pharmaceutical Ingredients Committee, APIC, has recently published a comprehensive How to do Document regarding electronic Common Technical Documents.
The European Commission has published a revised version of Part II of the EU GMP Guide – Basic Requirements for Active Substances used as Starting Materials. The EU’s decentralised procedure is being used as a model to accelerate the assessment of applications for generic medicines as part of the International Generic Drug Regulators PilotExternal link icon (IGDRP). The ICH M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk has reached Step 4 of the ICH process and is now entering the implementation period (Step 5).
FDAs Center for Drug Evaluation and Reseach (CDER) has published its yearly list of guidance documents and a list of new, revised and withdrawn guidances. Last week the FDA issued several policy documents regarding compounded drug products for human use, as part of the agency’s effort to implement the compounding provisions of the Drug Quality and Security Act (DQSA), enacted in November 2013. EU regulators have unveiled a new logo which will appear on the websites of all authorised online pharmacies known to provide authentic medicines. The Australian Therapeutic Goods Administration (TGA) is set to strengthen its collaboration with the European Directorate for the Quality of Medicines and HealthCare (EDQM).
EMA has published the long awaited Qualified Person (QP) declaration template and accompanying guidance concerning GMP compliance of API manufacture. The FDA, in partnership with other federal and international agencies, took action last week against websites that sell potentially dangerous, unapproved prescription drugs to U.S. As previously reported, the FDA is working on a system that will help to identify and trace dangerous drugs that are counterfeit, stolen or tainted throughout the whole supply chain. This month, the WHO has published a proposal for the revision of the supplementary guidelines on GMP: Validation, namely Appendix 7 – non-sterile process validation.
The European Commission has published the final version of Chapter 6 Quality Control of the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use on April 3, 2014.
The EMA has published the final version of the long awaited Guideline on Process Validation “Guideline on process validation for finished products – information and data to be provided in regulatory submissions” on February 24, 2014. The FDA has published a Draft Guideline for Industry entitled Analytical Procedures and Methods Validation for Drugs and Biologics.
The FDA initiates the Secure Supply Chain Pilot Program to enhance the security of imported drugs.
The CFDA has announced the adoption of the draft amendment to the Regulations for the Supervision and Administration of Medical Devices at the executive meeting of the State Council on February 12, 2014.
As announced by the Swiss Regulatory Authority Swissmedic, a Memorandum of Understanding in the area of therapeutic products was signed with the Korean Ministry for Food and Drug Safety (MFDS). Shortly after the FDA notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products due to particularly serious GMP deficiencies, health agencies in Europe are evaluating the FDA inspection findings to assess if these deviations from GMP have any implication on medicines on the European market.
The Health Ministry of India has constituted a sub-committee to prepare guidelines regulating the transportation of drugs in the country. Early this month, the China Food and Drug Administration (CFDA) issued an announcement on the implementation of the Good Manufacturing Practice for Drugs (2010 Revision) for sterile pharmaceutical products. According to pharmabiz, the government of India is planning a revision of its GMP guidelines – Schedule M – and considers making them on par with the WHO-GMP standards. The International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) published the results of their last meeting in Osaka: ICH Reviews Future ICH Topics and Its Organisation Towards Increased Engagement Globally.
Argus Safety is industry-proven and accepted, having been used for more than a decade at leading Pharmaceutical, Biotech, CRO, and IT Companies. One area receiving increasing attention is the opportunity to manage clinical content much more effectively.
According to industry analyst firm IDC Health Industry Insights, a new drug costs from $800 million to $1.2 billion to bring to market, and a quarter of this cost is content and regulatory requirements(2).
Hence, traditional information management systems and processes are risk-prone and increasingly problematic to business growth and success. This is a tall order that most life science companies have attempted to do so with electronic document management systems but have not been successful. With this approach, all clinical content in every document is organized in data components, each granularly identified, cataloged, and stored in the component library for reuse, tracking, traceability, and regular updates. The level of data reuse among documents is quite high – up to two-thirds of data is reused, according to an industry study(3). In fact, some information segments persist for many generations of document cycles and have life-spans which can be up to a decade in length. Shown above is a map of all seven documents types analyzed in this study with document sections expanded as information segments. All of the information in the resulting document is tracked back to reviews and discussions about each piece of the included content.

When done correctly, a life science company can set the underlying architecture required to support what will amount to millions of information segments in hundreds of thousands of documents to be created in the coming years. This approach provides granular visibility into different facets of the drug development lifecycle. A life science company taking a more sophisticated structured content management approach can better manage and automate the complex content requirements of the drug product life cycle.
The report was developed during a Member State Meeting on SSFFC in October 2014 in Geneva, Switzerland.
Food and Drug Administration (FDA) has published their yearly list of new and revised draft guidances CDER is planning to publish in 2015.
Food and Drug Administration (FDA) issued five draft documents related to drug compounding and repackaging to help entities in complying with important health provisions.
The EMA has published a revised version of the guideline "Guideline on similar biological medicinal products". The report has been presented in a revised format, following comments from a stakeholder focus group.
Delaying, refusing, denying – FDA inspectors often see themselves confronted with cooperation problems.
Representatives from forensic and customs laboratories, national medicines and food authorities, enforcement groups and the European Commission were invited to shed light on the problem of falsification of medicines. According to the EC this became necessary due to changes in various Annexes of the GMP Guide. FDA and the EMA (European Medicines Agency) announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. The life sciences industry spends several billion dollars a year on management of content and regulatory data(1).
Clinical content contained in mandated documents are vital assets, often supporting drug development for decades. Critical information is isolated in data and document silos, negatively affecting regulatory and operational compliance, strategic planning, innovation, and productivity. The basic problem with document management technology is that the content resides locked in the document itself, with no interconnecting network of core data or rules across the enterprise. This type of system relies upon the reuse of core data, applies specific reporting templates and business rules, and leverages content management to better manage the creation and use of clinical and regulatory documents. Examples can be found where information is created back in the discovery phase and persist well into Phase III and IV Clinical Trials. The ability to change and validate a single document template and apply the changes to hundreds if not thousands of documents is essential for today’s global regulatory environment. As clinical content documents are authored with a structured content management system, they can then be easily utilized by regulatory information management systems. The draft documents apply to outsourcing facilities, federal facilities, pharmacies and physicians. The regulation was issued on 25 November 2014 in the Official Journal of the European Union and has entered into force on 15 December 2014.
At the same time, the FDA, EMA, and other international regulatory bodies are expanding and amending requirements, clinical trials are becoming more complex, and effective partnering is becoming an ever more important capability. Thus the value of the clinical content is limited and it becomes easily lost and difficult to update. By reusing content, companies can dramatically reduce time to market by compressing document cycle times while improving document quality and speeding up regulatory interactions.
This ensures that the correct data is incorporated into the response, all submission requirements are met, electronic sign-offs are present, and the latest regulatory rules are fulfilled. One top global pharmaceutical illustrates the global benefits of this regulatory data management approach. Not only the new principles of ICH Q8, Q9, Q10 and Q11 constituted a new regulatory environment but also a continuous updating of Chapters of Part I of the EU GMP Guide or Annex 11 (computerised systems).
This system tracks global product submissions, contacts, commitments, milestones, registrations and on-going maintenance submissions. Tadikonda holds a Doctorate in Electrical and Computer Engineering from the University of Iowa, and a Bachelor of Technology in Electrical and Electronics Engineering from Birla Institute of Technology and Science, India. Another important document to be mentioned in connection with the new Annex 15 is the EMA guidance on process validation. This standardizes global regulatory processes and provides executives with timely reporting.

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