eCTD in Australia: key steps to start a successful submission
In this webinar you’ll learn how eCTD was introduced for Australia during the last few years and find out more on the current status of the introduction. Karl-Heinz Loebel (Pharmalex) will also give an overview of the Australian templates, their overall structure, and the standardized modules (M2-M5), as well as further specifics with a focus on module 1 and the envelope.
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DownloadUsing Real World Evidence to Transform Drug Development and Evaluation: Opportunities and Challenges
Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting regulatory expectations to an operating model that leverages data from disparate sources to aid business, regulatory, and healthcare decision making. Despite its many benefits, there is no single book or online source that systematically covers the latest development in the field. In this webinar, Dr. Yang will illustrate the potential uses of RWE in biopharmaceutical development, and present a wide range of RWE applications throughout the lifecycle of drug product development. The presentation will cover opportunities, challenges, and solutions in RWE.
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WatchSoftware Medical Devices – Considerations for Regulatory Compliance Success
Digital Health worldwide has had a massive growth in recent years, including new technologies in the healthcare space for both consumers and healthcare practitioners, such as wearable technologies, health apps and connected medical devices.
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WatchBayesian Expert Prior Elicitation to Aid Decision Making in Biopharmaceutical Development
Expert knowledge is a valuable source of information to augment available data or when interpretation/synthesis of data requires expert judgement. Prior elicitation is a key tool for translating this expert knowledge and judgement into a quantitative probability distribution that can then be used in the design, analysis, and interpretation of clinical and observational studies.
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WatchBench to Bedside: The need for an Integrated Product Strategy
Bringing new drugs to the market is becoming increasingly challenging and complex with multiple perspectives to be considered such as non-clinical, regulatory, clinical, CMC, Market access, statistics and operations among many others. In this webinar, we will discuss key elements needed to design and execute a bench to bedside integrated development strategy to help navigate these challenges in an optimized manner that increases the probability of regulatory approval and commercial success while managing costs and critical timelines. Case studies and client experience will be presented.
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WatchUsing R Shiny for Bayesian Prior Determination and Clinical Trial Design
Bayesian methods are becoming increasingly popular in the statistical design and analysis related to drug and medical device development. In early phases, they permit borrowing from auxiliary data and expert opinion in order to reduce trial sample sizes and save valuable development time. Their ability to deliver exact probability statements about the likelihood of safety, efficacy, and other key quantities makes them especially well-suited to predictions of late phase success, facilitating Go/No-Go and portfolio management decisions. However, Bayesian methods do require the user to specify a prior distribution, as a starting point for the analysis. In this webinar, we review the role and meaning of prior distributions, and how they can be elicited from past data and expert opinion. We then show this information can then be utilized to power a Bayesian clinical trial using a new Shiny app written in the popular R language. The app computes the design’s Type I error and power under both the elicitee’s informative prior, and a noninformative, reference prior. Other applications and exemplification will also be included.
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WatchBayesian Statistics: Model to predict recruitment and inform supply chain
The smooth running of patient enrolment is a key determinant of success for clinical trials. Yet many trials fail to complete on time due to delays in patient recruitment. Indeed, more than 80% of clinical trials do not reach recruitment targets on schedule (Huang et al., 2018). Despite efforts over multiple decades to identify and address barriers, recruitment challenges persist.
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WatchGene therapy products: regulatory expectations and challenges for the industry
Gene Therapy products continue to advance as unique therapeutic tools, offering potential cures to several genetic diseases for which there are no or limited treatment options.
Regulatory guidance on gene therapy products evolves at the same time, supporting the developers in their journey from early research phase to pivotal clinical studies, and eventually marketing authorization.
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WatchBayesian Methods for Joint Longitudinal and Survival Data
Many clinical trials and other medical and reliability studies generate both longitudinal (repeated measurement) and survival (time to event) data. Many well-established methods exist for analyzing such data separately, but these may be inappropriate when the longitudinal variable is correlated with patient health status, hence the survival endpoint (as well as the possibility of study dropout).
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WatchRemediation and Preparations: a recap of current state and what is next for Medical Devices and In Vitro Diagnostics in Europe under MDR and IVDR
During this session, the PharmaLex Medtech Expert, T.J. Thiel, will revisit the Medical Devices Directive (MDD, 93/42/EEC) and In Vitro Diagnostic Directive (IVDD, 98/79/EC) and their transitions to the Medical Device Regulation (MDR, 2017/745) and In Vitro Diagnostic Regulation (IVDR, 2017/746), respectively.
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WatchHealthcare system resilience during and after the pandemic
Pharmalex and Vintura have the pleasure to invite you to a discussion dedicated to healthcare system resilience during and after the pandemic from the perspective of Patient Access to innovation and optimal care.
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WatchBayesian Approaches for Incorporating Natural History Data in Studies of Rare and Pediatric Disease
In this webinar, after a very brief review of Bayesian adaptive clinical trial methods, we introduce our Bayesian responder approach to one-arm clinical trials in rare disease modeling, investigating the impact of both static and transient placebo effects.
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WatchBasic rules of pharmaceutical advertising in France
Are in you interested in knowing more about drug promotion in France? This webinar offers you a compact overview on how to promote a drug in France along with specifics and rules you need to be aware of. You will be introduced to a full spectrum of details: from the basic rules, to promotion for the public and for Healthcare Professionals (HCPs), as well as the so-called ‘visa’ rule (i.e. pre-approval system).
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WatchCritical Considerations for Mergers & Acquisitions - legal and regulatory overview on due diligence
2021 started with stellar news as Sanofi agreed to acquire British biotech Kymab for around $1.45 billion. It is a chequered flag for the start of this seasons M&A activity for Life Sciences companies. Great expectations? PharmaLex and VWV ponder legal and regulatory solutions for supporting M&A deals, takeovers, business moves, leveraging, spin-outs, carve-outs and strategic partnerships.
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WatchUnlocking BLA, NDA, IND Submissions Key considerations and LORENZ docuBridge training
The first part of this webinar will provide you with the theoretical background to plan, prepare and execute highly efficient and compliant eCTD sequences for the FDA. The second half of this webinar will feature a live demonstration of compiling submissions based on the BLA template using LORENZ docuBridge software.
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WatchExcipient Risk Assessment as per the EU Guidance and SMARTRISK as a solution
This webinar will discuss the key points in the performance of a compliant excipient risk assessment and how the PharmaLex tool, SMARTRISK, can help provide a solution for Marketing Authorization Holders that need support with the management of Excipient risk.
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WatchBayesian Adaptive Approaches in Rare and Pediatric Disease
In this webinar, after a very brief review of the Bayesian approach, we illustrate its use in simple data combination methods, including traditional two-step approaches, as well as ones using power priors, commensurate priors, and robust mixture priors for incorporating sensibly downweighed versions of the auxiliary information.
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WatchEudravigilance: overcoming challenges and gaining efficiencies with SMARTVIGISCREEN
SMARTVIGISCREEN is a cloud-based software solution that processes incoming ICSRs automating the analysis of company vs non-company cases and taking away manual efforts. The tool is GxP validated system according to GAMP 5 guidelines and CFR Title 21 Part 11 compliant. Moreover, SMARTVIGISCREEN is fully validated for both EVW and MLM download process and can easily be integrated with ICSR Management process, generating up to 70% efficiency increase.
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WatchSoftware Suite for the Life Cycle of Analytical Methods & Bioassays: Gain Trust in your Results
In this webinar three Software-as-a-Service (SaaS) solutions – Enoval, Seelva and Transval – will be presented, which meet current and newly developed regulations for two key steps in the lifecycle of analytical methods and bioassays: Validation and Transfers. All three solutions enable them to obtain fully compliant reports in minutes and implement the proposals of the USP 1210 chapter by using statistical tolerance intervals and total errors to determine whether the analytical methods are suitable for the purpose. At the end of the study, you will have more confidence in the analytical results obtained with them.
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WatchMarketing a drug in France, what are the responsibilities of an exploitant?
This webinar offers an overview of the exploitant status in France together with an overview of key French regulations in that matter. An exploitant is a pharmaceutical company based in France, having a “Pharmacien Responsable” and having been authorised by French Agency. Roles and responsibilities cover various activities, such as: promotion, pharmacovigilance, medical information, distribution, sales, batch recall, complaints, shortage …. Alternatively, companies may choose to market a drug in France from another European country (EU) as long as they comply with the French regulation.
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WatchIntroduction to Bayesian Methodologies in CMC
Chemistry, manufacturing, and control (CMC) is a crucial stage in drug development. In CMC, activities such as defining product characteristics and modeling manufacturing processes are carried out to ensure the safety, consistency, and efficiency of drug products. In this webinar, we will demonstrate the importance of applying Bayesian statistics to CMC via several case studies.
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WatchQbD and Process Characterization
Product quality is achieved through process validation. During process characterization, manufacturers are using Quality By Design tools in order to acquire knowledge on the process. In this webinar, process scientists will be introduced to important concepts that will ease their communication with statisticians.
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WatchBiotech Drug Development Challenges and Case Studies (CMC)
This talk provides an overview of biotech drug development and focusses in the most common CMC pitfalls we have recently observed and how to avoid them.
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WatchBayesian Power, Assurance and Probability of Success
In this webinar you will learn the important difference between probability and certainty in order to successfully implement a clinical trial. The more uncertainties you include in your clinical trial, the better you can assess your chances in the follow-up. In this webinar, you will learn important details about how to make your clinical trial a success, together with our two experts Maud Hennion and Arnaud Monseur.
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WatchElectronic Submission in the EAEU - the challenges
The first part of this webinar will provide an overview and update on the new Regulatory legislation in the Eurasian Economic Union (EAEU) and its impact on pharmaceutical companies intending to apply for new or to preserve existing Marketing Authorisations in the Region. It will also explain the key features of the mandatory eCTD-like EAEU electronic submission format.
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WatchVirtual Audits Webinar
The webinar on Virtual Audits will present the current regulatory expectations, benefits and challenges of virtual auditing and will share expertise on the planning, preparation, performance and reporting for a virtual audit.
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WatchMedical Device Clinical Evaluation Reports (CERs) -What you need to know
The webinar presents on four key aspects of CERs: Clinical Trials, demonstration of equivalence, literature reviews and analysis of post-market data. These are critical components of Clinical Evidence Reports, and those which are often misunderstood by authors. The webinar explores what these aspects mean for Clinical Evidence Reports and how they can be applied, delving deeper into key parameters and considerations.
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WatchImplementation of an efficient QRM program
Quality Risk Management has been a hot topic for many years in the Pharmaceutical Industry and appropriate management of risk in our processes and procedures has become the foundation on which Quality compliance is based. This webinar will discuss how to get the most benefit from a QRM program so that it delivers its full potential as a powerful tool for decision making, prioritisation, efficiency, continuous improvement, training and knowledge management.
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WatchGood Statistical Practices - Discovery to Clinical Research
For 15 years the scientific literature repeatedly underlines the important lack of reproducibility and replicability of studies in biomedical and psychological research. As a consequence, several scientific organizations (journal, scientific societies, universities, national agencies) have identified some root causes to this issue and proposed good research practices to improve the reproducibility of the results.
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WatchRisk Management of the presence of Nitrosamines in medicines
The presence of nitrosamines, potentially carcinogenic compounds, in some chemically synthesized drugs has led to the withdrawal and supply of several drugs from the market and has raised the alarm among regulatory agencies around the world, especially in Europe. As a result of these events, a new strategy for the control and monitoring of these compounds must be defined by the pharmaceutical laboratories.
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WatchSafety considerations for an Rx to OTC Switch Program
The OTC Drug Monograph identifies specific requirements for a class of drug products. If product complies, manufacturer does not need FDA approval before marketing. However new ingredients targeting are not developed OTC monograph process. These products made it to the market via a New Drug Application. These drugs can arrive via OTC switch, of which there are 2 types: a full or partial switch.
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WatchClinPHLEX |Strategic & Cross-Functional Partnership
ClinPhlex is a global, cross-functional, clinically-focused team that works in close collaboration with a client to provide innovative, customized, efficient, strategic and tactical solutions to optimize and de-risk development. Our expertise and global experience in clinical development, clinical-regulatory strategy, biostatistics and biostatistical regulatory strategy, clinical and translational pharmacology as well as clinical research/operations and program management allow ClinPhlex to evaluate and improve your current position.
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WatchAn Overview to Non clinical testing: why? when? what?
Why is non-clinical testing needed? This webinar will deliver you an overview of the non-clinical framework in the EU. Furthermore different products are shown as examples to illustrate the process of non-clinical testing in praxis.
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WatchVendor Management Programs - Ensuring Success!
Vendor management is a challenge for bio/pharmaceutical companies throughout all phases of product lifecycle. Using effective vendor management tools can promote good working relationships, leading to favorable vendor performance and successful outcomes.
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WatchEarly-Phase Modelling – Costs and Effectiveness in Pharma
This webinar offers an overview of the benefits early-phase, health-economic modelling can provide, at a stage when the outcome of the product development program is still largely unknown. Early-Phase Modelling balances between accuracy and manageability, and represents an easy to grasp, conceptual overview of your product and its potentials regarding reimbursement.
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WatchOverview of the biotech drug development pathway
This webinar offers an overview of the multidisciplinary (CMC, non-clinical and clinical) requirements for the development of biotech products, outlines the regulations, highlights critical requirements and summarizes common CMC pitfalls and how to avoid them.
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WatchEnvironmental Risk Assessments for Human Medicinal Products
Dr. Angela Vogt-Eisele, Senior Manager Scientific Affairs, Pharmalex will give you a clear overview on Environmental Risk Assessments for Human Medicinal Products especially about Challenges and Recent Developments.
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WatchEudraVigilance – The fundamental tool for Pharmacovigilance
In this complimentary webinar, PharmaLex experts discuss updates on the EudraVigilance database and shed light on the Electronic Reporting System. Learn how to download Individual Case Safety Reports (ICSRs) and understand the EudraVigilance data analysis system (EVDAS).
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WatchBrexit: An update on preparations for MA holders
PharmaLex experts will provide updates for our UK and International audiences answering queries on how, as a Marketing Authorisation Holder (MAH), you can prepare for Brexit. Following the outcome of the UK’s referendum on membership of the European Union, we have analysed the most feasible Brexit scenarios and what their impacts could be for the Pharmaceutical industry.
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WatchStrategy For A Successful Quality By Design Implementation
Bruno Boulanger holds a PhD in Experimental Psychology from the University of Liège (Belgium). Since 2000, Dr. Boulanger is Senior Lecturer at the Université of Liège, in the School of Pharmacy, teaching Design of Experiments and statistics. He organizes and contributes to Non-Clinical Statistics in Europe.
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WatchRegulatory Landscape for Tissue, Cell and Gene Therapy
Dr. Buljovcic is a Biologist and has 15 years of experience working in the Regulatory Affairs business, including 10 years specializing in Tissue, Cell and Gene therapies.
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WatchMergers & Acquisitions related activities - A RA perspective
Dr. Adam King has nearly 30 years of experience working in the Pharmaceutical industry, with over 18 years specializing in global Regulatory Affairs and Regulatory Consultancy.
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WatchA comprehensive approach to regulatory portfolio management
Dr. Constanze Burkhardt’s experience in Strategic Outsourcing and Program Management has enabled her to build a strong team environment in a matrix management setting with a high commitment to the drug development and LCM process.
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WatchOptimize your biosimilar development strategy
Zeb Younes has over 16 years´ of experience in biopharmaceutical / biosimilar development lifecycle from proof of concept through to, and beyond commercialization with both laboratory and desk based experience in process development, purification, formulation, method development, characterisation, validation, comparability, release and stability testing.
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