Veristat’s Post

The German Parliament Bundestag adopted the revised Medical Research Act. The legislation among other aspects, will: ➡ Facilitate the implementation of decentralized clinical trials ➡ Create a legal basis for the publication of standard contractual clauses for trials ➡ Accelerate the conduct of mono-national clinical trials ➡ Task a specialized ethics committed in charge of special procedures at federal level ➡ Limit price confidentiality to pharmaceutical companies with research departments located in Germany ➡ Hold price negotiations first, then give manufacturers incentives to select whether the price should be confidential or public 🔗https://hubs.li/Q02HtRDN0 #EU #clinicalresearch #clinicaltrials

With a backlog of more than 300 #drug #reimbursement applications (increasing) #Switzerland‘s #pharma market loses its attractiveness. The fact that some reimbursement decisions are taken quickly cannot whitewash the increasing unpredictability. The #Swiss system works well for “me toos” - not for real #innovations.

How can society obtain the #antibiotics it urgently needs while adhering to #stewardship measures? Pull incentives reward those who have successfully developed a novel antimicrobial product by increasing or securing future revenues. Focusing on the potential #benefits of the drug for #publichealth, governments may offer producers a #remuneration system that is independent of sales volume as an incentive to foster the development of new antibiotics. Read more about this and other aspects of #regulation of #pharmaceuticals in the latest issue of "im dialog" from Dr. Melissa Newham, Postdoctoral Researcher at the ETH Zurich. https://lnkd.in/eDhK3-wJ #innovation, #researchanddevelopment, ETHZ, CSS

Diversity in clinical trials is an important aspect of furthering public health and promoting greater access and awareness to medical interventions. Check out our alert on FDA's latest guidance on clinical trial diversity. #clinicaltrials #diversity #medicalproducts #FDA Tina Papagiannopoulos Matthew Piscitelli

#Patient safety is a core responsibility of the pharmaceutical industry ⚠️  And that safety is, of course, my primary concern. My teams and I are committed to improving patient safety every day.   #Counterfeit medicines put patients' health at risk and undermine the reputation of pharmaceutical companies. #Traceability throughout the #supplychain, from production to distribution, ensures that consumers are protected from counterfeit, tainted or dangerous medicines.   Just last week, our experts Georg Schick and Frank Bixenmann spoke at the #Parenteral #Packaging Conference of the PDA - Parenteral Drug Association about how seamless traceability from a single source, including GMP process parameter tracking up to pallet aggregation, works and which solutions Uhlmann Pac-Systeme has to offer. An essential component of every Track & Trace application from Uhlmann is the in-house developed software for recording, aggregating and managing serialization data from the machine via line management to location management. The topic is particularly relevant in view of the fact that the illegal trade in counterfeit medicines continues to be an issue – as is currently the case in Austria. Although the number of counterfeit medicines seized in 2023 decreased slightly compared to the previous year, a total of 801,863 counterfeit and illegal medicines are still alarming.   Alexander Herzog, Secretary General of PHARMIG, warns of the risks of counterfeit medicines, which are often of inferior quality and can even be fatal – and I can only agree with that. While the risks are life-threatening, the solutions are already available today. https://lnkd.in/eqvgf3ZH

Interesting approach in EU’s possible new law (pharma package) to improve antibiotic resistance situation. It incorporates numerous essential measures, such as implementing prescription requirements for antibiotics in certain EU countries. Additionally, there are elements that require further validation, such as a voucher system for drug approvals, enabling pharmaceutical companies to exchange these vouchers for an extension of patent protection for more lucrative medicinal products. https://lnkd.in/dny7FC7z #AntimicrobialResistance #EUHealthcare #AntibioticResistance #PublicHealth #Pharmaceuticals #DrugApprovals #HealthPolicy #HealthcareReform #EURegulations #Medicine #HealthcareIndustry #MedicalResearch #HealthcareInnovation #EUInitiatives #HealthcareSystems #HealthcareTrends #EUHealthStrategy #HealthcareSolutions

Check out Dr. Matt Chalmers's article today. Dr Chalmers Path to Pro - Clearing up the medical lie comment The medical industry operates, shedding light on the influence of pharmaceutical companies and the dissemination of healthcare guidelines. The importance of questioning established norms and encourages individuals to seek out alternative perspectives for making informed decisions about their health. Follow his Substack for more: https://lnkd.in/geEBX-eP Follow Matt Chalmers's Linked Click the link to read the entire article: https://lnkd.in/gH8Yk5zK #HealthcareTruths #MedicalIndustryInsights #AlternativePerspectives #FunctionalMedicine #HealthAwareness #HealthcareChoices

Notification for Applicants and Sponsors of Clinical Trials – The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, and the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)) provide recommendations on complex clinical trials in mono-national clinical trials in the early development phase (early phase complex clinical trials). Read the recommendations here 👉 https://lnkd.in/ezeHvYdY #clinicaltrials

Clinical trials are research studies performed on humans to evaluate medical, surgical, or behavioral interventions. They are the primary method used to determine whether new treatments (like drugs, devices, or procedures) are safe and effective. Here are some key characteristics of clinical trials: 1. Phases Phase I- Tests the safety, dosage range, and side effects of a new treatment in a small group of people (20-80). Phase II - Expands the study to a larger group (100-300) to further evaluate its safety and effectiveness. Phase III - Involves a larger group of participants (1,000-3,000) to confirm its effectiveness, monitor side effects, and compare it to commonly used treatments. Phase IV -Conducted after a treatment is approved for use by the public to gather additional information on its risks, benefits, and optimal use. 2. Randomization 3. Blinding Single-blind - The participants do not know which group they are in, but the researchers do. Double-blind - Neither the participants nor the researchers know who is in the treatment or control group. This is done to prevent bias in treatment administration and assessment of outcomes. 4. Control Groups 5. Informed Consent 6. Eligibility Criteria 7. Endpoints 8. Regulatory Oversight 9. Data Monitoring 10. Statistical Analysis These characteristics ensure that clinical trials are conducted systematically, ethically, and with scientific rigor, ultimately contributing to the development of new and effective medical treatments. #clinicaltrials #clinicalresearch #cpa #communitypharmacistaid #pharmacy

$12.1 billion. That’s how much Big Pharma lavished on America’s doctors from 2013 to 2022, according to a new study, for things like travel, meals, drinks, honoraria, consulting, and outright gifts. About 826,000 physicians received such payouts from drug or device makers over that ten-year span. Some orthopedic surgeons raked in as much as $4.8 million! But even something as seemingly innocent as a luncheon sponsored by Big Pharma has been shown to influence the decisions doctors make. Because there’s no such thing as a free lunch. Big Pharma knows exactly what it’s getting for investing well over a billion dollars a year — which it can easily afford due to its relentless fleecing of the American people — to influence our nation’s doctors. Multiple studies demonstrate that payments from pharmaceutical companies and device manufacturers are linked to increases in prescriptions for specific medications and the use of particular devices. That, in turn, can lead to inflated costs for patients, insurers, and Medicare. There is no reason that Big Pharma lavishing money on doctors should be legal. Congress can and must change the law so that the American people know we’re getting the medicines and devices we need rather than whatever Big Pharma happens to be influencing doctors to prescribe. Tell Congress: The American people deserve to know that we’re getting the drugs and medical devices we need, uninfluenced by payments to doctors from Big Pharma. Pass legislation to ban pharmaceutical companies and medical device manufacturers from buying influence with doctors. Thanks for taking action. For progress, - Robert Weissman, President of Public Citizen