Bioglan Pharma Plc

DUBLIN, May 22, 2023 /PRNewswire/ -- The "Medical Device Regulations in the Middle East and North Africa Training Course" conference has been added to ResearchAndMarkets.com's offering. The size of the medical device market in the Middle East has expanded over recent years and this trend is forecast to continue. The growth is due in part to innovations in technology as the majority of Middle Eastern countries are early adopters of technological advancement, which provides opportunities for medical device companies. The regulatory environment in the region is also developing and this annual seminar will provide an essential overview of the key requirements for product approvals for medical devices in the Middle East and North Africa. The programme will focus on the regulatory requirements and developments in individual countries and include interactive discussion sessions to allow you to exchange experiences with our expert faculty and other delegates. Benefits of attending: Gain a valuable introduction to the medical device markets: countries, numbers, economical facts and trends, regulatory environment Familiarise yourself with medical device regulations in the countries of the Middle East and North Africa Understand medical devices and their classification Clarify procedures for company and product registration Discuss recent developments in the region Meet, network and share experiences with other industry colleagues Key Topics Covered: The medical device markets in the Middle East and North Africa (MENA) Markets and Culture Healthcare Business culture Economic overview Regulatory environment and characteristics General regulatory requirements Company and product registration Key documents needed Basic structure of a dossier Regulatory summary Medical Devices and their classification What is a medical device Different classes of products Individual Country Presentations: Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen Recent Developments in the Region Harmonisation activities Countries with new regulatory requirements for medical devices Countries in the process of establishing regulatory guidance for obtaining marketing authorisations Discussion sessions will take place throughout the two days Speakers: Heba Hashem Middle East and Africa Associate Director PPD Heba has been working with Regulatory Affairs in the Middle East for more than 25 years. She has a Pharmaceutical and Business background being a graduate of the Faculty of Pharmacy (Cairo University), RAC certified in addition to an MBA at Maastricht School of Business. For the past 20 years Heba held the position of Middle East & Africa Regulatory and Quality Head at different Pharmaceutical and Medical Device companies; Gambro, Bayer and Novo Nordisk. Heba is now the Middle East and Africa Associate Director at PPD where she is providing regulatory consulting services and training to Health Care companies. Ilona Putz Founder PULONA Ilona Putz founded PULONA Emerging Markets based in the UAE which is dedicated to creating and developing tailor-made business concepts for clients in the healthcare sector across the Middle East. She has worked in the pharmaceutical industry since 1988 for companies like MSD, SmithKline Beecham, Karl Engelhard and HEXAL where she has held the position of Regulatory Affairs Regional Manager, responsible for regulatory affairs and later on in commercial operations for countries in the Middle East and Africa. Between 2005 and August 2008 she was Regional Head, Middle East, for Sandoz International, Germany, responsible for all commercial and business development activities. She consults also for RegAff for the Middle East which is the only Global Specialist Regulatory Affairs company with a broad geographical coverage, and for Emergo Group, which is a global consultancy company for Medical Devices. She spoke also for DIA (Drug Information Association) Switzerland on "Clinical Trials in the Middle East", DIA Europe Meeting, Geneva 2011. For more information about this conference visit 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. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

FRANKFURT (Reuters) - Positive data on BioNTech and U.S. partner Pfizer Inc’s COVID-19 vaccine is an unlikely success for the married couple behind the German biotech firm, who have devoted their lives to harnessing the immune system against cancer.Pfizer said on Monday said its experimental vaccine was more than 90% effective in preventing COVID-19 based on initial data from a large study. FILE PHOTO: FILE PHOTO: The headquarters of biopharmaceutical company BioNTech in Mainz, Germany July 31, 2018. REUTERS/Ralph Orlowski/File Photo/File Photo Pfizer and BioNTech are the first drugmakers to show successful data from a large-scale clinical trial of a coronavirus vaccine. The companies said they have so far found no serious safety concerns and expect to seek U.S. emergency use authorization later this month. From humble roots as the son of a Turkish immigrant working at a Ford factory in Cologne, BioNTech Chief Executive Ugur Sahin, 55, now figures among the 100 richest Germans, together with his wife and fellow board member Oezlem Tuereci, 53, according to weekly Welt am Sonntag. The market value of Nasdaq-listed BioNTech, which the pair co-founded, had ballooned to $21 billion as of Friday’s close from $4.6 billion a year ago, with the firm set to play a major role in mass immunisation against the coronavirus. “Despite his achievements, he never changed from being incredibly humble and personable,” said Matthias Kromayer, board member of venture capital firm MIG AG, whose funds have backed BioNTech since its inception in 2008. He added Sahin would typically walk into business meetings wearing jeans and carrying his signature bicycle helmet and backpack with him. Doggedly pursuing his childhood dream of studying medicine and becoming a physician, Sahin worked at teaching hospitals in Cologne and the southwestern city of Homburg, where he met Tuereci during his early academic career. Medical research and oncology became a shared passion. Tuereci, the daughter of a Turkish physician who had migrated to Germany, said in a media interview that even on the day of their wedding, both made time for lab work. Together they honed in on the immune system as a potential ally in the fight against cancer and tried to address the unique genetic makeup of each tumour. Life as entrepreneurs started in 2001 when they set up Ganymed Pharmaceuticals to develop cancer-fighting antibodies, but Sahin - by then a professor at Mainz university - never gave up academic research and teaching. They won funding from MIG AG as well as from Thomas and Andreas Struengmann, who sold their generic drugs business Hexal to Novartis in 2005. That venture was sold to Japan’s Astellas in 2016 for up to $1.4 billion. By then, the team behind Ganymed was already busy building BioNTech, founded in 2008, to pursue a much broader range of cancer immunotherapy tools. That included mRNA, a versatile messenger substance to send genetic instructions into cells. DREAM TEAM For MIG’s Kromayer, Tuereci and Sahin are a “dream team” in that they reconciled their visions with the constraints of reality. The BioNTech story took a twist when Sahin in January came across a scientific paper on a new coronavirus outbreak in the Chinese city of Wuhan and it struck him how small the step was from anti-cancer mRNA drugs to mRNA-based viral vaccines. BioNTech quickly assigned about 500 staff to project “light speed” to work on several possible compounds, winning pharma giant Pfizer and Chinese drugmaker Fosun as partners in March. Matthias Theobald, a fellow oncology professor at Mainz university who has worked with Sahin for 20 years, said his tendency towards understatement belies a relentless ambition to transform medicine, exemplified by the leap of faith to a COVID-19 vaccine. “He is a very modest and humble person. Appearances mean little to him. But he wants to create the structures that allow him to realise his visions and that’s where is aspirations are far from modest,” Theobald said. Sahin told Reuters on Monday the read-out amounted to an “extraordinary success rate” but that he did not know earlier in the year how difficult the task overall would be. “It’s certainly not something that you would easily voice as a serious scientist, but it was within the realms of possibility from the beginning.” GRAPHIC: U.S. biotech shares jump -