Latest news with #seminar
Yahoo
25-06-2025
- Health
- Yahoo
Join the July 3 2025 Online Course on Sustainable Medical Device Design & Manufacture
Join this seminar to explore sustainable strategies in medical technology. Discover options, benefits, and drivers, and learn how to implement change for your company. Gain practical advice, assess risk, and develop achievable strategies. Earn 6 CPD hours and a certificate of completion. Dublin, June 25, 2025 (GLOBE NEWSWIRE) -- The "Sustainable Design and Manufacture for Medical Devices Training Course (ONLINE EVENT: July 3, 2025)" has been added to offering. Sustainability in medical technology, as in all industries, is increasingly no longer an option. It's not a question of "if" - it's a question of "how". This seminar will give you an in depth understanding of what sustainability options exist, what the benefits are, what drives them and how to choose which will work for your company. It will also provide practical advice on how to implement change. Benefits of attending Gain an understanding of how sustainability objectives can be made to fit with YOUR organisation and what you should be aiming to achieve Learn how to assess risk and develop a strategy that delivers worthwhile results in a realistic timeframe Appreciate where to start, how to manage change and how to justify the investment by measuring improvements Certifications: CPD: 6 hours for your records Certificate of completion Who Should Attend: Medical industry leaders Sustainability leaders Product owners Manufacturing managers Design heads Business development managers Anyone interested in sustainable design and manufacture Course Agenda: Background Focus: where does sustainable design and manufacture fit into the overall sustainability picture? What are the drivers for sustainability in YOUR industry/organisation? What are the barriers? What has your organisation done so far and why? Did it work? If not, why not? Understanding how to move forward Stakeholders in sustainable design and manufacture Risks - organisational, technical, regulatory and market Understanding the synergy between design, manufacture and remanufacture Planning change Appetite for change - selling the idea, getting stakeholders on board and assessing future market acceptance/demands Understanding the benefits - how sustainability can add value to your organisation and your products Sharing the vision and getting commitment/support Understanding risk - acknowledging that this is new ground and identifying what you don't know you don't know Planning phased implementation - disruptive change and how to manage it Feasibility analysis - the answer to the question "should we adopt sustainable manufacture" - might be no! Implementing change Where to start - design, manufacture, remanufacture or all three? How to "do" sustainable design. How have others done it? What can we learn? How suitable is it for medical? How to implement a recovery and remanufacturing loop. What can we learn from other industries? What external forces exist and how do we address them? Where to find support and how to keep the regulators happy Starting small and working up - balancing risk with manageable rates of progress and measuring success Scaling up, managing expectations and finding the optimum rate of change Making the financial case - how does sustainability pay for itself? Q&A and key takeaways For more information about this training visit About 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. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ 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
Yahoo
24-06-2025
- Business
- Yahoo
FDA Regulatory Compliance for Drug and Biotech Products - 2 Day Virtual Training Course, July 16-17, 2025: Enhance Compliance Skills with Expert-Led Training and Resources
Enhance your regulatory compliance skills with a comprehensive course on FDA regulations for biologics and drug development. Learn practical applications for ensuring compliance with the FD&C Act and GMP regulations in drug manufacturing and testing. Attendees receive presentation slides, a participation certificate, a Q&A session, and free compliance handouts. Dublin, June 24, 2025 (GLOBE NEWSWIRE) -- The "FDA Regulatory Compliance for Drug and Biotech Products (ONLINE EVENT: July 16-17, 2025)" training has been added to offering. Enhance your knowledge of Regulatory Compliance with this specialized live seminar focused on the essential practices mandated by the Federal Food, Drug, and Cosmetic Act. Dive into the practical applications necessary for ensuring adherence to FDA regulations in biologics and drug development, a critical component for both sponsors and regulatory agencies. This seminar offers an insightful exploration of the graded approach in compliance, vital for pharmaceutical and biotechnology companies striving to meet Good Manufacturing Practice (GMP) regulations effectively. This includes the meticulous management needed in manufacturing, testing, and controlling clinical supplies, as well as overseeing commercial product outputs. This live training Seminar includes the following for each registered attendee: A copy of the presentation slides by download A certificate of participation for attendee training records Q/A Session Free Handouts on FDA Regulatory Compliance This course will benefit professionals involved in working with pharmaceutical and Biotech products and management involved in drug development and FDA Regulatory Compliance: QA/QC analytical chemists QA/QC directors, managers Investigators in QA/QC Manufacturing/Production Research and Development Project management Manufacturing personnel CROs analysts Technical liaison Regulatory affairs personnel CMC specialists Senior quality managers Quality professionals Regulatory professionals Compliance professionals Quality auditors Document control specialists New hires, as well as Managers, Directors, and Vice Presidents of Regulatory Affairs and Quality Assurance. Course Agenda: Day 1 FDA and its Statutory and Regulatory Requirements FDA's Structure and Purpose The Federal Food, Drug and Cosmetic Act The Code of Federal Regulations Guidane, Policy Documents and Compliance Manuals The Evolution of FDA Law Brief Overview: The Products FDA Regulates and Their Pathways to Market Drugs Medical Devices Food & Dietary Supplements Cosmetics Tobacco Veterinary Products Universal Requirements Establishment Registration, Product Listing, User Fees, etc. FDA Drug Development and Approval Process Considerations Statutory and Regulatory Provisions Citizen Petitions Approvals and Clearances The Drug IND, NDA, ANDA and Orphan Designation Biologic's BLA Medical Device 510(k) and PMA Combination Products Veterinary INAD, NADA, ANADA, MUMS FDA Drug Approval Process Case Study # 1: Suitability Petitions Case Study #2: Paragraph IV Certification Post Approval Submissions QbD product development and design Key elements of IND, NDA/ANDA applications and FDA expectations Electronic CTD format and content, most submitted through ESG (Electronic Submissions Gateway) Post approval changes to process, methods etc. Regulatory Filings Risk analysis Statutory and Regulatory Compliance The Concepts of "Adulteration" and "Misbranding" Identifying Non-Compliance Product Label and Labeling The Internet Approval and Clearance Facility Inspections Adverse Events Recalls Trade Complaints and Anonymous Tips FDA's Compliance Options, Historical Case Examples & FDA's Website Form 483s Untitled Letters Warning Letters Import Alerts Seizures Recalls Consent Decrees Temporary and Permanent Injunctions Civil and Criminal Prosecution The Park Doctrine Other Compliance Bodies DOJ, FTC, EPA, the States, NAD Management's Role and Responsibilities in Compliance Communication, Implementation and Decision Making Quality Policy and Resourcing Personnel Training Escalation of issues to upper management Corrective and Preventive Actions (CAPA) Gap Analysis Facility Audits and Inspections Internal Company Audits Training the Employees Use of Third-Party Auditors Auditor qualifications understanding Learn Key critical audit areas Internal auditing procedures and schedule Supplier and Customer Audits FDA Inspections Foreign Inspections The FDA Form 483 Strategies for Successfully Responding to a Form 483 including Inspection Observations and Violations The Written Response Communication with FDA Disagreements with Form 483 Observations When the Form 483 Becomes a Warning Letter Course Agenda Day 2 Manufacturing and Quality Controls for Drug Products Management's Role and Involvement Complying with Good Manufacturing Practices "cGMPs" Laboratory Quality Controls Standard Operating Procedures What Makes a Good SOP How to Write an Adequate SOP Strategies for Drafting Recalls and Market Withdrawals FDA Jurisdiction and Authority Stock Rotations Corrections Market Withdrawals Recalls Recall Classifications How to Conduct a Product Recall Customer Communication FDA Communication Documentation Strategies for Mitigating the Chances of a Recall Pharmacovigilance Definitions of Significant and Serious Adverse Events Recording, Investigating and Reporting Complaints FDA Communication Strategies for Dealing with Complaints Customs, Detentions and Import Alerts The Process Holds and Detentions Seizure and Destruction Remediating The Import Alert Rx Drug Promotion and Advertising Risk Considerations "Fair Balance" Elements & Considerations Brief Summary Boxed Warning Important Safety Information False and Misleading Claims Fair Balance Superiority Claims Testimonials Market Research Quality of Life Data Other Considerations Enforcement Action Examples Emerging Compliance Trends Counterfeit drug issues and growing concerns Drug shortage crisis Biosimilar approval pathways Others Other Compliance Issues Questions & Answers and Closing Thoughts For more information about this training visit About 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. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ 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
Daily Mail
01-06-2025
- Business
- Daily Mail
Roxy Jacenko steps out wearing a staggering $1.5 MILLION worth of diamonds at Sydney speaking event
Roxy Jacenko flaunted her wealth on Friday as she stepped out at the Ivy Ballroom in Sydney for her In Conversation seminar. The PR maven, 45, decked herself out in diamonds as she attended the speaking event, ensuring she was the centre of attention in an angelic white dress. With her blonde tresses pulled back in an artful high pony, Roxy clasped a string of diamonds around her neck before adding glittering accessories, believed to be worth a staggering $1.5 million. She slipped on a gold Versace watch which retails for a jaw-dropping $2,320 and stood out against her white Simkhai mini dress worth $870. Roxy then stacked her other wrist with three bracelets - a gold and platinum bangle studded with gems, and a diamond chain, worth over a cool million all up. From A-list scandals and red carpet mishaps to exclusive pictures and viral moments, subscribe to the DailyMail's new showbiz newsletter to stay in the loop. The socialite completed her bejewelled look with simple diamond studs, a gold ring on one hand and her massive diamond wedding ring on the other. Roxy's lavish display comes after she slammed working from home arrangements, describing it as a 'lazy' work mentality. Speaking at her exclusive In Conversation event in Sydney, the PR dynamo said the key to a good business operation is interacting and networking - in person. 'We stopped picking up the phone, stopped going to things, stopped networking altogether. Zoom became an easy way of doing business,' Roxy told the crowd. 'It's a lazy way of doing business. The fact is, people want an experience, they want a memory. We need to start doing that networking again.' Roxy runs a PR firm and Ministry of Talent, a talent agency which represents influencers like Costeen Hatzi and reality TV star Ash Pollard. She believes as working from home arrangement continues, employees are increasingly forgetting the importance of being around people. 'Everything has become digital, but people want the touch-and-feel experience. This is why I am doing this (seminar), there is an importance in being around people,' she explained. The socialite completed her bejewelled look with simple diamond studs, a gold ring on one hand and her massive diamond wedding ring on the other 'We lost that connection during Covid. We became lazy. Instead of going to a face-to-face meeting you would have a meeting over Zoom or Teams.' 'I get to an end result because I do it face-to-face. People want to be treated like real people, they want to belong. It's about community,' she added. 'We want to see a familiar face, to see a connection. So much more comes from face-to-face than staring at a screen. It's s**t on Zoom, it doesn't have the same connection.' She went on to describe a recent business meeting with an investment banker in Singapore. When she walked into the company's office there were no employees at their desks because everyone was working from home. She said it made her think twice about working with the company, and in turn, they lost her business. 'When you walk into our MOT office, it's light and bright, there's orchards and music, There's a vibe!' she said. WFH became the norm for white-collar workers during the Covid lockdowns from 2020 - 2022, and has since become entrenched in many industries, with more than a third of Australians now doing their job at home. Some companies are pushing to get staff back into the office more often in the belief it is a more efficient way of working, but the Productivity Commission recently concluded the opposite.
Daily Mail
28-05-2025
- Business
- Daily Mail
Roxy Jacenko reveals the real reason her husband Oliver Curtis has 'disappeared', her huge plans for teen daughter Pixie and a terrifying near-death experience at a business event
She is set to bring her famous 'In Conversation with Roxy Jacenko' seminar back to life this week in Sydney. But one person who will not be joining the PR dynamo is her husband Oliver Curtis. Amid swirling rumours the couple's marriage is on the rocks, Roxy has firmly denied they have split and revealed the real reason the former high-flying investment banker has seemingly vanished off the grid. While the mother-of-two, 44, frequently posts to social media including posts with her children Pixie, 13, and Hunter, 11, Roxy's husband of 13 years rarely features on her Instagram feed. Speaking exclusively to Daily Mail Australia, she said that while it might seem like Oliver has 'disappeared', it was more of a case of business as usual. From A-list scandals and red carpet mishaps to exclusive pictures and viral moments, subscribe to the DailyMail's new showbiz newsletter to stay in the loop. Roxy Jacenko has revealed why husband Oliver Curtis has apparently vanished off the grid Oliver, a former Macquarie banker and the son of wealthy mining industry executive Nick Curtis, could be on the road to becoming a billionaire. He turned a $250,000 personal investment in Firmus Technologies into a whopping $81 million last year. His business is based in Singapore and the company has a facility in Launceston, Tasmania. 'Oli has never been keen on social media – he works hard and wants to focus on that without the noise of social media,' Roxy explained. 'My work is in social media so its an important part of my day to day, it's a business for me – its not for him and I respect that.' The family relocated to Singapore in 2024, with Roxy frequently jetting back to Australia for work and Oliver conspicuously absent during her Down Under trips. Roxy said that it was Oliver's tireless work ethic that keeps him from travelling more frequently. 'His office is based in Singapore and he has a large operation there, he spends time back and forth to Launceston, Tasmania where he also has a facility,' she said. Despite her current long commute from Singapore to Australia, Roxy revealed that the family has no immediate plans for a permanent move back Down Under. While the PR maven, 44, frequently posts to social media including posts with her children Pixie, 13, and Hunter, 11, Roxy's husband of 13 years rarely features on her Instagram feed 'Oli has never been keen on social media – he works hard and wants to focus on that without the noise of social media,' Roxy revealed. 'My work is in social media so its an important part of my day to day, it's a business for me – its not for him and I respect that.' 'I have no plans to come back to live in Sydney, coincidently if you asked me this a year ago it would have been a very different answer,' she said. 'I come back and forth for work as my business, The Ministry of Talent and to spend time with my Mum. 'Other than that, I am happy being in Singapore and have the incredible opportunity to travel the world as everything is so close.' Roxy said when it comes to Singapore, the pros definitely outweigh the cons - humidity (which she's now used to) and the high cost of living. She added that her children are adapting well to their adopted homeland, while also providing a more convenient base for Pixie, who is set to finish her schooling in Switzerland where she will be mingling with other socialites' children. 'With Pixie heading to finish school in Switzerland it's a great location,' she said. 'Hunter is also excelling in school in Singapore and has the most incredible group of friends he's met from all around the world.' Roxy is also preparing to host another of her popular In Conversation events on Friday despite describing the live seminar events as 'cursed' in the past. The family recently relocated to Singapore, with Roxy frequently jetting back to Australia for work Despite her current long commute from Singapore to Australia, Roxy revealed that the family has no immediate plans for a permanent move back Down Under 'I have no plans to come back to live in Sydney, coincidently if you asked me this a year ago it would have been a very different answer,' she said. 'I come back and forth for work as my business, The Ministry of Talent and to spend time with my Mum' Roxy has very good reason to be wary, with the PR maven facing an almost near death experience back in 2015 during her Tips and Tricks seminar. Never one to cancel an event, Roxy made the dangerous decision to check herself out of hospital following rhinoplasty surgery. 'It was my first ever In Conversation event I had two sessions booked at Sydney's Intercontinental, Double Bay for 120 people per session – there was NO way I could cancel it in my mind, people had taken time off their week to attend and paid good money to learn,' she said. 'To this day ill never forget it, I had been in Infectious diseases ward in Prince of Wales for a week, my face was swollen up like a soccer ball and I looked like a horror story. Roxy added that she soldiered on despite her husband Oliver and mother Doreen saying she was 'mad' for going on with the show. 'Oli and my mother Doreen both thought I was mad, but I booked a stylist to sort me out two looks - [celebrity stylist] Marina Didovich and Norman Gonzales - who is the master of hair and make-up to give me a glow up. 'What he did with contouring made me look more tennis ball than soccer ball. I had the nurses disconnect me from the IV and a driver collect me and off I went. 'Between sessions which was about 4 hours I went back to hospital and got back on the IV … till the next session.' Roxy is also preparing to host another of her popular In Conversation events in Sydney later this month, and despite describing the live seminar events as 'cursed' she pushes on regardless Her 2019 In Conversation event also made headlines after entrepreneur Anthony Hess walked on stage and abused Roxy with inappropriate and vulgar language. 'That was awful,' she said. 'Looking back at it and his motives for causing such chaos based on desire for notoriety and fame were sick. I have never looked for "fame", I have been fortunate to have familiarity from my craft. I have always said, be famous or known for being good at something – not for what you do wrong.' The fracas didn't end their either, with Roxy claiming that after the event Anthony graffitied the walls of her Paddington office. Roxy said that the ordeal was a tough one to deal with. 'Waking up to a call that my name was spray painted from one end of Sydney's Eastern suburbs to the other was distressing,' she said. 'Not only my own commercial premises where my some 20+ staff had to walk into that morning but also on any blank space from Paddington to Bondi, was nothing short of horrible. She added that the vulgarities expressed in the graffiti was even tougher for her young children to grasp. 'What was worse was my young children at the time having to see such words as "Roxy is a c***" and "Roxy is a Fraud" on their way to school. Roxy has very good reason to be wary, with the PR maven checking herself out of hospital, to host her 2015 Tips and Tricks seminar, following rhinoplasty surgery Her 2019 In Conversation event also made headlines after she claimed entrepreneur Anthony Hess walked on stage and abused Roxy with inappropriate and vulgar language The fracas didn't end their either, with Roxy claiming that after the event, Anthony had graffitied the walls of her Paddington office 'What was worse was my young children at the time having to see such words as "Roxy is a c***', and 'Roxy is a Fraud' on their way to school 'I was forced to quickly go and buy my own cans of spray paint from the local Mitre 10 and spray OVER my name until I had the help from local councils and a friend who runs a large painting company to remove and repaint all the spaces he covered.' Roxy applied for an AVO against Anthony which was rejected by a magistrate. 'It's a fact, between altercations and then appearing on stage with a blood infection and IV in my arm its fair to say that I need to invest in more than an evil eye,' she said of the upcoming show on Friday. 'That said, one thing I guess it does show is no matter what set back you've got to get up and get on with it, no matter what.' She added that it was fan demand that inspired her to host another seminar. 'I have had SO many people reach out via social media and email asking me to bring the in person seminar back I thought I would do ONE last show,' she said. 'With everything becoming so very in-personal because of our obsession with online I actually felt it was important – in person is KEY in business and people seem to have forgotten that.' After Friday, Roxy is planning to put her feet up - if only for a little while. 'Next stop is Bali with the family for mid-term break, a short 2-hour flight from Singapore – I haven't been in about 10 years so I am really looking forward to it and the new Regent property in Cannguu that we are staying at,' she explained. 'I've become Dora the Explorer!' Tickets for In Conversation with Roxy Jacenko Sydney 2025 are on-sale at
Yahoo
19-05-2025
- Business
- Yahoo
Middle East and North Africa Medical Device Regulations Training Course: Understand Classification and Registration Requirements (ONLINE EVENT: June 16-17, 2025)
Explore the burgeoning medical device market in the Middle East at our annual seminar, focusing on regulatory requirements and technological advancements. Gain insights and network with experts on device classification, registration procedures, and regional developments. Earn CPD credits while enhancing your industry knowledge. Dublin, May 19, 2025 (GLOBE NEWSWIRE) -- The "Medical Device Regulations in the Middle East and North Africa Training Course" training has been added to 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 Certifications: CPD: 12 hours for your records Certificate of completion Who Should Attend: The event will be of particular interest to: Anyone involved in regulatory affairs for medical devices in the Middle East and North Africa Anyone new to the region Anyone interested in an update of recent developments 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 training visit About 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. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ 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 +353-1-416-8900Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
