University of Basel

DUBLIN--( BUSINESS WIRE )--The "Pharmaceutical Regulatory Affairs in China Training Course" conference has been added to ResearchAndMarkets.com's offering. This seminar will provide an invaluable overview of how to gain and maintain a successful pharmaceutical marketing authorisation in the People's Republic of China (PRC), including Hong Kong, Macau and Taiwan. The two-day course offers a comprehensive overview of critical components necessary for obtaining and preserving successful marketing authorization within the region. It will delve into the recent regulatory reforms and the drug regulatory systems that impact this process. Participants will gain insights into both import and local manufacture registration procedures, alongside detailed coverage of clinical product development, including Chemistry, Manufacturing, and Controls (CMC) regulatory requirements. The course also provides a practical interpretation of these topics, aiming to equip attendees with applicable knowledge. Additionally, it offers a valuable platform for delegates to exchange experiences, enhancing learning through shared insights and discussions. Who Should Attend: This seminar will be of particular interest to all those who need to learn about successful marketing authorisation applications and in-market regulatory compliance in this region. You will find this seminar useful both as an introductory or refresher course. Previous delegates have included scientists and technical staff in regulatory affairs and registration departments, medical directors, and personnel from analytical research and development, clinical development, quality assurance, new business development and regulatory authorities. Benefits of attending: Gain an overview of the regulatory procedures in the region Understand and assess the impact of recent regulatory reforms Discuss clinical product development and Chinese-specific approaches Understand requirements for import and local manufacturing registration Discuss product registration strategies Certifications: CPD: 12 hours for your records Certificate of completion Agenda: Day 1 General introduction to the PRC and the pharmaceutical market Commercial and cultural background P.R. China - Drug Regulatory Systems Regulatory authorities Recent regulatory changes Regulations and guidelines Drug classification systems Import and local manufacture registration Data requirements Registration requirements Labelling requirements P.R. China - Clinical Product Development Regulatory aspects of clinical development Recent regulatory changes Documentation needs including CMC Regulatory requirements including GCP aspects Chinese-specific approaches Multinational clinical trials Hong Kong SAR Background overview Regulatory authorities Regulatory requirements and procedures Specific market aspects Macau SAR Brief overview of regulatory aspects Day 2 P.R. China - Regulatory Strategies P.R. China - Health Authority Interactions P.R. China - Maintenance Taiwan (Republic of China) Cultural background Regulatory authorities Regulations and guidelines Drug classification systems Data requirements Country-specific matters P.R China - Recent Developments Speakers: Mónica Dressler-Meyer DRA Manager Management Forum Mónica is DRA Manager based in Switzerland with several years of regulatory experience. She has spent many years in DRA working with different pharmaceutical companies with responsibility for Asia Pacific and lately also for development activities in other regions. Prior to this, she worked at F. Hoffmann-La Roche in Switzerland where she gained several years' experience in industry basics and pre-clinical research. Mónica has a Degree in Chemistry and Biochemistry from Basel University. Alan Chalmers Pharmacist Management Forum Dr Alan Chalmers is a pharmacist with over 35 industrial experiences mainly in the field of pharmaceutical regulatory affairs. A graduate of Strathclyde University in Glasgow with a B.Sc. in Pharmacy with specialisation in Pharmaceutical Technology, his Ph.D. at Manchester University was in Pharmaceutical Formulation. From 1975-1978 he was Development Officer and Clinical Trials Pharmacist of Allen & Hanburys (part of the then Glaxo group). In 1978 he joined Ciba-Geigy in DRA. Over 20 years were spent with Ciba-Geigy/CIBA/Novartis in all aspects of regulatory affairs including head of a group company DRA in Canada and for many years as Head of Pharma International regulatory affairs. He has been consultant to the IFPMA, WHO and other international bodies and was Chairman of the Organising Committee of the initial IFPMA Asian Regulatory Conferences in Hong Kong and Singapore and Rapporteur to the more recent conferences in China and Malaysia. Since 1998 he has been an independent regulatory consultant and is Director of his own consultancy company Pharma International in Switzerland. He has also been director of two UK and Swiss registered pharmaceutical companies with specialised responsibility for international regulatory strategy. More recently as accredited by Swissmedic, Dr. Chalmers is a Qualified Person supporting several Swiss pharmaceutical companies trading internationally with pharmaceuticals and medical devices. He is published, and his publications include a textbook on International Pharmaceutical Registration, Active Pharmaceutical Ingredients and as Swiss correspondent to the Regulatory Affairs Journals Pharma and Medtech. Since 2012 he has been a member of the Editorial Board, Scrip Regulatory Affairs. For more information about this conference visit https://www.researchandmarkets.com/r/smaxv9 About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

BASEL, Switzerland & PHILADELPHIA--( BUSINESS WIRE )--RhyGaze, a biotechnology company based in Basel, Switzerland and Philadelphia, Pa., USA, today announced that it has secured a Series A financing of USD 86 million. The round was led by GV (Google Ventures), alongside Arch Venture Partners, F-Prime Capital and founding investors BioGeneration Ventures and Novartis Venture Fund, who contributed USD 11 million to an earlier seed round. RhyGaze was founded on intellectual property exclusively licensed to the company by the Institute of Molecular and Clinical Ophthalmology Basel (IOB), a scientific institute led by Director Botond Roska, M.D., Ph.D., who is a scientific co-founder of RhyGaze. This funding will enable further development of RhyGaze’s lead clinical candidate, a novel gene therapy for optogenetic vision restoration in diseases causing blindness. Activities to be supported include formal pharmacology and toxicology testing, a non-interventional, observational study to assess potential clinical endpoints in patient groups eligible for the therapy and a first-in-human clinical trial to test the safety, tolerability and potential efficacy of the lead candidate. “ This program exemplifies a key goal of IOB: combining our deep understanding of retinal biology and vision with breakthrough technologies to develop novel therapies for vision loss,” said Dr. Roska. Added Bence György, M.D., Ph.D., a group leader at the IOB, RhyGaze scientific co-founder and board member and Assistant Professor at the University of Basel: “ We are excited to see this program moving forward because it uniquely presents the opportunity to restore high-resolution vision in blind patients.” “ I look forward to partnering with colleagues at IOB to bring this novel gene therapy to patients, and I am excited about the team we are assembling to pursue this important goal,” said Dr. Katherine High, CEO of RhyGaze and formerly co-founder, President and Head of R&D at Spark Therapeutics. “ RhyGaze will determine over the next few years whether the compelling data generated at IOB can translate to clinical outcomes. If that is true, this innovation will have a world-wide impact in improved therapeutics for blindness.” RhyGaze operates from Basel, Switzerland and Philadelphia, Pa., USA. About RhyGaze RhyGaze is a cutting-edge biotechnology company based in Basel, Switzerland, and Philadelphia, Pa., USA, focused on developing gene therapies for retinal diseases causing blindness. Founded on pioneering research from the Institute of Molecular and Clinical Ophthalmology Basel (IOB), RhyGaze aims to restore vision and transform the lives of patients worldwide. IOB scientists Drs. Botond Roska, Bence György and Charles Gubser are the scientific founders of RhyGaze. The name RhyGaze derives from the Basel-German word for the Rhein (Rhy), on the banks of which the IOB is located. About IOB At the Institute of Molecular and Clinical Ophthalmology Basel (IOB), basic researchers and clinicians work hand in hand to advance the understanding of vision and its diseases, and to develop new therapies for vision loss. IOB started its operations in 2018. The institute is constituted as a foundation, granting academic freedom to its scientists. Founding partners are the University Hospital Basel, the University of Basel and Novartis. The Canton of Basel-Stadt has granted the institute substantial financial support.

ANDOVER, Mass. & HAIFA, Israel--( BUSINESS WIRE )-- MeMed , a leader in host-response diagnostics, today announced the addition of three distinguished experts to its advisory board to accelerate its mission of addressing the global challenges of sepsis and antimicrobial resistance (AMR) through innovative diagnostic solutions. These new members bring decades of experience in medicine, industry, and healthcare policy, strengthening MeMed’s work in host-response technologies, which combine machine learning with rapid measurements of the immune response to transform infectious disease care. The advisory board now includes: Beat Müller , M.D., Professor of Medicine, University of Basel, and a global authority on procalcitonin diagnostics and sepsis care. Dave Hickey , former Executive Vice President and President of the Life Sciences segment for BD, and a seasoned expert in in-vitro diagnostics (IVD). David Shulkin , M.D., the ninth Secretary of the US Department of Veterans Affairs and Board Member at Sanford Health, with deep expertise in U.S. healthcare delivery and policy. Prof. Müller emphasized the critical role of advanced host-response diagnostics: “AMR and sepsis are deeply interconnected challenges, and host-response diagnostics are the next frontier in addressing them. I look forward to working with MeMed to further strengthen clinical outcome data for their FDA-cleared MeMed BV test and the in-development FDA Breakthrough-designated MeMed Severity test. These tools have the potential to significantly improve clinical decision-making by providing actionable insights into bacterial versus viral infections and predicting the likelihood of suspected sepsis severity.” Mr. Hickey, a veteran professional in the IVD industry, said: “Integrating traditional IVD with host-response and machine learning is a major step forward. MeMed’s approach is expected to enhance patient management throughout the sepsis continuum of care, addressing unmet needs in both centralized hospital labs and decentralized settings. I am excited to help shape their commercial strategy and expand partnerships to make these innovations widely accessible and make sure they impact as many patients as possible.” Dr. Shulkin spoke on the importance of scaling MeMed’s diagnostics in the U.S. healthcare system: “Sepsis and AMR are among the most pressing challenges in U.S. healthcare. MeMed’s host-response solutions have the potential to revolutionize care delivery, reduce unnecessary antibiotic use, and optimize resources in a cost-effective way. I look forward to helping operationalize them to address these critical needs.” “We are privileged to work alongside such an extraordinary group of leaders,” said Eran Eden, Ph.D., CEO and Co-Founder of MeMed. “Their expertise will help us advance the field of host-response diagnostics and bring these tools to clinicians and patients worldwide.” MeMed BV® and MeMed Key are 510(k) FDA, CE-IVD (IVDR certified) and available in the US and EU. MeMed Severity™ is currently in development and has not been cleared for sale by any regulatory authority. About MeMed At MeMed , our mission is to translate the immune system’s complex signals into simple insights that transform the way diseases are diagnosed and treated, profoundly benefiting patients and society. MeMed BV® is the first FDA-cleared host-immune response test for accurately distinguishing between bacterial and viral infections in 15 minutes. MeMed Severity™ is a groundbreaking host-response test designed to predict the likelihood of progression to severe outcomes in patients with suspected acute infection or sepsis. It is in development and has been awarded FDA Breakthrough Designation. Follow and connect with MeMed via LinkedIn , X , and Facebook .