University of Strathclyde

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.

LONDON, GB / ACCESSWIRE / January 9, 2025 / Nanomerics Ltd., a private speciality pharmaceutical company today announced that it had completed 28 consecutive days of administration in its OC134 Phase I trial - the SUNLIGHT trial. Dosing twice daily (12 h apart) of the healthy study participants with MET eye drops and OC134 eye drops commenced in December 2024 and was completed in January 2025.All volunteers (n=10) completed the dosing schedule without drop outs and volunteers will report for follow up assessments in February 2025. There were no adverse events of moderate or severe severity reported during the clinical phase of the trial and there were no clinically significant individual changes from baseline or notable trends in safety assessments including safety bloods, vital signs, eye examination, 12 lead ECGs and urine analysis. Single topical administration of MET and OC134 eye drops on 56 consecutive occasions were well tolerated by healthy volunteers under the condition of the trial. Approval had been granted recently for the OC134 and MET tolerability study by the UK Medicinal and Healthcare Products Regulatory Agency (MHRA) and the study was conducted by Quotient Sciences at its Nottingham, UK Phase I study site according to Good Clinical Practice guidelines.OC134 is an eye drop medicine candidate indicated for the topical treatment of moderate to severe allergic conjunctivitis, a condition for which a suitable non-steroidal topical ocular treatment, does not currently exist.OC134 is powered by Nanomerics\' Molecular Envelope Technology (MET), a non-irritant ocular penetration enhancer. Nanomerics\' MET is a platform ocular penetration enhancer, that has been shown in preclinical studies to increase the penetration of active pharmaceutical ingredients (APIs) into the front of the eye; increasing ocular deposition up to 18-fold, when compared to conventional formulations. In preclinical studies, Nanomerics\' MET also demonstrated the delivery of APIs to the retina from eye drops. Nanomerics has a pipeline of ocular assets that may now be tested in clinical studies and ultimately launched for the benefit of patients. Nanomerics\' MET is now a clinical stage ocular excipient.Professor Andreas G. Schätzlein, Nanomerics\' Chief Executive Officer said,\"We are pleased that Nanomerics has completed the dosing phase of its first clinical study - the SUNLIGHT trial - with Nanomerics\' Molecular Envelope Technology (MET) powered eye drops. This is an important step which will now enable us to move forward our ocular pipeline for later stage clinical testing. We are indebted to our clinical trials partner - Quotient Sciences - for working with us on this Good Clinical Practice trial.\"Dr Nand Singh, Medical Director at Quotient Sciences commented,\"We are pleased that the First-In-Human trial has completed the clinical phase of the study at our Nottingham, UK clinic for Nanomerics\' OC134 Phase 1 SUNLIGHT trial. This trial marks a significant milestone in the development of a new therapeutic approach aimed at developing advanced treatments for moderate to severe allergic conjunctivitis.\"About NanomericsNanomerics Ltd is a speciality pharmaceutical company with state-of-the-art laboratories based in London, UK. Nanomerics was founded to commercialise its biocompatible polymer technologies for drug delivery and other applications. Nanomerics\' proprietary technology is based on world leading know-how and scientific leadership in polymer nanotechnology. Nanomerics creates uniquely differentiated, patented pharmaceutical assets, underpinned by high quality science. For example, the company\'s Molecular Envelope Technology (MET) is a unique patented biocompatible polymer that delivers a step change in target tissue bioavailability. The founding scientists, Professor Dame Ijeoma F. Uchegbu and Professor Andreas G. Schätzlein developed the technology at the Universities of Strathclyde and Glasgow and, latterly at the UCL School of Pharmacy. Pharmaceutical product candidates in development include the eye drops: OC134 for the treatment of moderate to severe allergic conjunctivitis, OC137 for the treatment of retinal diseases and OC135 for the treatment of glaucoma. For more information, please visit www.nanomerics.comFor press enquiries contact:Pedro MargaridoHead of Operations, Nanomerics Ltd.[email protected]About Quotient SciencesQuotient Sciences is a drug development and manufacturing accelerator providing integrated programmes and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, Quotient saves precious time and money in getting drugs to patients. Everything Quotient does for its customers is driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast, because humanity needs novel therapeutic solutions, fast. Quotient Sciences has been recognized as a multi-year winner of the CRO Leadership Awards in 2021, 2022, and 2024 and of the CDMO Leadership Awards in 2023. For more information, visit quotientsciences.com.For press enquiries, contact:Erica FearnleyExecutive Director, Strategic Marketing at Quotient Sciences[email protected]Rachael HeathSenior PR Manager at RaMarketing & PR[email protected]Forward-Looking StatementsThis news release contains \"forward-looking statements\" as defined by the Private Securities Litigation Reform Act of 1995. Nanomerics cautions readers that forward-looking statements are based on management\'s expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially. Forward-looking statements reflect our analysis only on their stated date, and Nanomerics takes no obligation to update or revise these statements except as may be required by law.SOURCE: Nanomerics Ltd

LONDON, UK / ACCESSWIRE / December 11, 2024 / Nanomerics Ltd., a private speciality pharmaceutical company today announced that dosing had commenced in its OC134 Phase I trial - the SUNLIGHT trial. Following approval in November 2024 from the UK Medicinal and Healthcare Products Regulatory Agency (MHRA), dosing of the first volunteers with both Nanomerics' MET eye drops and OC134 eye drops, took place this week. The clinical testing of Nanomerics' eye drop assets is being done by Quotient Sciences at its Nottingham, UK facility. OC134 is an eye drop medicine candidate indicated for the topical treatment of moderate to severe allergic conjunctivitis, a condition for which a suitable non-steroidal topical ocular treatment, does not currently exist.OC134 is powered by Nanomerics' Molecular Envelope Technology (MET), a non-irritant ocular penetration enhancer. Nanomerics' MET is a platform ocular penetration enhancer, that has been shown in preclinical studies to increase the penetration of active pharmaceutical ingredients (APIs) into the front of the eye; increasing ocular deposition up to 18-fold, when compared to conventional formulations. In these preclinical studies, Nanomerics' MET also demonstrated the delivery of APIs to the retina from eye drops. Nanomerics has a pipeline of ocular assets that may now be tested in clinical studies and ultimately launched for the benefit of patients.Professor Andreas G. Schätzlein, Nanomerics' Chief Executive Officer said,"Nanomerics has been working towards this day for many years and we are very proud that we have been able to commence clinical testing with our lead ophthalmology asset. This day marks the culmination of many years of hard work with excellent team members, collaborators and advisors. This is a major value creation step for the company and we are now poised to develop medicinal products powered by our world beating non-irritant ocular penetration enhancer - Nanomerics' Molecular Envelope Technology (MET)."Dr Nand Singh, Medical Director at Quotient Sciences commented,"We are excited to begin clinical testing at our Nottingham, UK clinic for Nanomerics' OC134 Phase 1 Sunlight trial. This marks an important step forward in developing advanced treatments for moderate to severe allergic conjunctivitis."About NanomericsNanomerics Ltd is a speciality pharmaceutical company with state-of-the-art laboratories based in London, UK. Nanomerics was founded to commercialise its biocompatible polymer technologies for drug delivery and other applications. Nanomerics' proprietary technology is based on world leading know-how and scientific leadership in polymer nanotechnology. Nanomerics creates uniquely differentiated, patented pharmaceutical assets, underpinned by high quality science. For example, the company's Molecular Envelope Technology (MET) is a unique patented biocompatible polymer that delivers a step change in target tissue bioavailability. The founding scientists, Professor Ijeoma F. Uchegbu and Professor Andreas G. Schätzlein developed the technology at the Universities of Strathclyde and Glasgow and, latterly at the UCL School of Pharmacy. Pharmaceutical product candidates in development include the eye drops: OC134 for the treatment of moderate to severe allergic conjunctivitis, OC137 for the treatment of retinal diseases and OC135 for the treatment of glaucoma. For more information, please visit www.nanomerics.com.For press enquiries contact:Pedro MargaridoHead of Operations, Nanomerics Ltd.[email protected]About Quotient SciencesQuotient Sciences is a drug development and manufacturing accelerator providing integrated programmes and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients. Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast, because humanity needs novel therapeutic solutions, fast. Quotient Sciences has been recognized as a multi-year winner of the CRO Leadership Awards in 2021, 2022, and 2024 and of the CDMO Leadership Awards in 2023. For more information, visit quotientsciences.com.For press enquiries, contact:Erica FearnleyExecutive Director, Strategic Marketing at Quotient Sciences[email protected]Rachael HeathSenior PR Manager at RaMarketing & PR[email protected]SOURCE: Nanomerics Ltd