Regulatory science

Countdown to Crunch Time: How Early and Continual Regulatory Engagement Leads to Regulatory and Commercial Success, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Thursday, March 28, 2024
Innovation, MBA, Regulatory science, RAC, Business operations, Risk management

TORONTO, March 28, 2024 /PRNewswire-PRWeb/ -- In the webinar "Countdown to Crunch Time: How Early and Continual Regulatory Engagement Leads to Regulatory and Commercial Success," industry-leading regulators with extensive experience in both the biopharma and the CRO space engage in a not-to-be-missed, dynamic conversation. Participants will uncover vital strategies for navigating regulatory pathways seamlessly. By avoiding common pitfalls that could jeopardize submission deadlines, attendees will gain invaluable insights into safeguarding project timelines.

Key Points: 
  • By avoiding common pitfalls that could jeopardize submission deadlines, attendees will gain invaluable insights into safeguarding project timelines.
  • TORONTO, March 28, 2024 /PRNewswire-PRWeb/ -- In the webinar "Countdown to Crunch Time: How Early and Continual Regulatory Engagement Leads to Regulatory and Commercial Success," industry-leading regulators with extensive experience in both the biopharma and the CRO space engage in a not-to-be-missed, dynamic conversation.
  • This webinar will shed light on the often-overlooked advantages of early and continual engagement with regulatory agencies and how proactive collaborative efforts in the early stages can significantly enhance efficiency and mitigate risks.
  • Register for this webinar today to gain insights into the advantages of early and continual regulatory engagement.

bioMérieux and the Food and Drug Administration Launch Research Collaboration to Improve Microbial Detection Tools to Combat Food-Borne Pathogens

Retrieved on: 
Wednesday, February 28, 2024
Senior, Research, Regulatory science, Escherichia coli, Food safety, FDA, Safety, Food, Center for Food Safety, Cyclospora cayetanensis, Risk, CFSAN, Health, Applied science, Market access, Listeria monocytogenes, Disease, Infection, Food security, Software, Public, Vaccine

CHICAGO, Feb. 28, 2024 /PRNewswire/ -- bioMérieux, a world leader in in vitro diagnostics for 60 years, has entered into a strategic research collaboration with the US Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN), Offices of Applied Research and Safety Assessment (OARSA) and Regulatory Science (ORS) to develop tools to combat food-borne pathogens. The agreement will pave the way for many innovative projects to improve detection and microbial characterization systems for pathogens that pose a risk in foods.

Key Points: 
  • The agreement will pave the way for many innovative projects to improve detection and microbial characterization systems for pathogens that pose a risk in foods.
  • bioMérieux and the US Food and Drug Administration to collaborate on strategic research to combat food-borne pathogens.
  • "bioMérieux is incredibly proud to enter into strategic, collaborative research with the FDA.
  • bioMérieux provides diagnostic solutions (systems, reagents, software and services) which determine the source of disease and contamination to improve patient health and ensure consumer safety.

Cloud and Medical Device Cybersecurity: The FDA's 2023 Guidelines, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Monday, January 15, 2024
Research, Cloud computing, Lead, Risk assessment, Regulatory science, Sternum, Food, Safety, SBOM, FDA, Medical device

TORONTO, Jan. 15, 2024 /PRNewswire-PRWeb/ -- Discover an informative webinar decoding The Food and Drug Administration's (FDA) 2023 guidelines about the cloud and medical device cybersecurity landscape. Medical device cybersecurity has undergone a game-changing transformation with The FDA's updated 2023 guidelines, seamlessly integrating both medical device and cloud computing aspects.

Key Points: 
  • Attendees will learn how to continuously monitor devices and cloud systems, and their software code, to meet the FDA guidelines.
  • TORONTO, Jan. 15, 2024 /PRNewswire-PRWeb/ -- Discover an informative webinar decoding The Food and Drug Administration's (FDA) 2023 guidelines about the cloud and medical device cybersecurity landscape.
  • Medical device cybersecurity has undergone a game-changing transformation with The FDA's updated 2023 guidelines, seamlessly integrating both medical device and cloud computing aspects.
  • Join this insightful webinar to be part of a forward-thinking community eager to master the future of medical device cybersecurity in the cloud era.

Certara Announces 300th Regulatory Submission Milestone Using its Technology-enabled Services and Software

Retrieved on: 
Tuesday, September 19, 2023
Medical Affairs Bureau, Central nervous system, Drug development, NDS, Therapy, Marketing, Type 2, Pediatrics, New Drug Application, European Medicines Agency, Health care, CMC, Clinical trial, NDA, Therapeutic Goods Administration, Cancer, CTA, Regulatory science, CNS, Common Technical Document, EMA, Chemistry, Shanda, Investigational New Drug, Patient, Pinnacle, Certara, Medicines and Healthcare products Regulatory Agency, MAA, Rare, TGA, FDA, Health Canada, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, BLA, Food, MHRA, Pharmaceutical industry, Risk management, Medical device, EU, Swiss Medical Students' Association

Certara has supported clients' global regulatory submissions across a wide range of therapeutic areas including cancer, rare diseases, central nervous system (CNS) diseases, and pediatrics.

Key Points: 
  • Certara has supported clients' global regulatory submissions across a wide range of therapeutic areas including cancer, rare diseases, central nervous system (CNS) diseases, and pediatrics.
  • “As the global regulatory drug development environment changes at an ever-increasing pace, Certara has combined regulatory writing expertise with technology platforms that streamline a complex process,” said Demetrius Carter, Sr. Vice President, Regulatory Sciences & Medical Affairs at Certara.
  • In addition to regulatory submission services, Certara offers a software portfolio that saves time and resources in submission development.
  • The software portfolio includes:
    Pinnacle 21™ software used to facilitate all aspects of preparing clinical trial data for regulatory submissions.

ProPharma Expands Regulatory Sciences Team in the Japan and Asia-Pacific Region with Addition of Neama Baho

Retrieved on: 
Wednesday, August 30, 2023
Odyssey, Baho, RCO, Regulatory science, Associate, Patient, Neama Riadh, Health, Safety, Regulation, Management, Pharmaceutical industry

RALEIGH, N.C., Aug. 30, 2023 /PRNewswire-PRWeb/ -- ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of Odyssey Investment Partners, announces the expansion of its Regulatory Sciences team with the appointment of Neama Baho as Associate Vice President, Regulatory Sciences. In her new role, Baho will oversee regulatory operations in Japan and Asia-Pacific markets.

Key Points: 
  • With 25+ years of progressive leadership experience in the international pharmaceutical industry, Neama Baho will join ProPharma Group as Associate Vice President, Regulatory Sciences, overseeing regulatory operations in Japan and Asia-Pacific markets.
  • RALEIGH, N.C., Aug. 30, 2023 /PRNewswire-PRWeb/ -- ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of Odyssey Investment Partners , announces the expansion of its Regulatory Sciences team with the appointment of Neama Baho as Associate Vice President, Regulatory Sciences.
  • Baho expressed her enthusiasm: "I am excited to join ProPharma's Regulatory Sciences team.
  • Baho's addition to the Regulatory Sciences team underscores this commitment and positions ProPharma for continued success in the future.

Innovating Oncology Trials: Breaking Access Barriers, Optimizing Protocols and Navigating Regulatory Challenges, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Wednesday, June 28, 2023
RCO, Regulatory science, Medicine, Medical imaging, Nursing, Biostatistics

Toronto, June 28, 2023  /PRNewswire-PRWeb/ --In an effort to illuminate and discuss the challenging aspects of clinical trials in oncology, a free webinar titled "Innovating Oncology Trials: Breaking Access Barriers, Optimizing Protocols and Navigating Regulatory Challenges" is set to take place.

Key Points: 
  • The featured speakers will discuss strategies for improving patient access and diversity in oncology clinical trials, including initiatives to address barriers and engage underserved populations.
  • Attendees will gain an understanding of the implications of the changing regulatory landscape for oncology clinical trials.
  • Toronto, June 28, 2023 /PRNewswire-PRWeb/ --In an effort to illuminate and discuss the challenging aspects of clinical trials in oncology, a free webinar titled "Innovating Oncology Trials: Breaking Access Barriers, Optimizing Protocols and Navigating Regulatory Challenges" is set to take place.
  • This webinar aims to shed light on three challenging aspects of clinical trials in oncology: The need for innovative study design for novel therapies; Patient access and diversity; And navigating the ever-changing regulatory landscape.

22nd Century Group (XXII) Highlights Recent TCORS Symposium Findings

Retrieved on: 
Thursday, May 25, 2023
Smoke, Smoker, Modified risk tobacco product, Heated tobacco product, Nicotine, Pacific Century Group, Public, Policy, MRTP, CTP, Research, Tobacco, Language, Regulatory science, Government, Menthol, Congress, Big Tobacco, Agricultural Appropriations Act of 1922, Century, Agriculture, XXII, Center for Tobacco Products, Health, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Smoking, Food, Disease

BUFFALO, N.Y., May 25, 2023 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), a leading biotechnology company dedicated to improving health with reduced nicotine tobacco, hemp/cannabis and hops advanced plant technologies, today provided comments following the recent Tobacco Centers of Regulatory Science (TCORS) Symposium and attempts to use funding limitations to inhibit actions by the U.S. Food and Drug Administration to advance its top tobacco harm reduction policies.

Key Points: 
  • Together, these policies are expected to dramatically reduce the rates of smoking in the U.S., saving millions of lives and countless healthcare dollars.
  • Additionally, 22nd Century opposes the tobacco industry’s attempts to influence congress and interfere with the U.S. Food and Drug Administration’s (FDA) plans to advance these policies.
  • “As a Company, 22nd Century stands in support of the FDA and members of Congress in the fight to end the harms of highly addictive tobacco products,” said John Miller, president of tobacco products for 22nd Century Group.
  • To inform adult smokers of the product's distinctive purpose, the FDA requires 22nd Century to include the statement "Helps You Smoke Less" on every package of VLN® sold.

PM360 Announces Winners of The Ninth Annual ELITE 100 Awards

Retrieved on: 
Tuesday, May 16, 2023
Nexium, Data science, Marketing, GoodRx, EVP, Hospira, Associate, Cardinal Health, Patient, McCourt, HR, Disease, Eli Lilly and Company, Constipation, Attention, Snow, Diagnosis, Entrepreneurship, Growth, Digital marketing, Immunology, FAAN, Engagement, Organon, Caregiver, PR, Ironwood Pharmaceuticals, Exception, COVID-19, IBS-C, Health, ELITE, Boehringer Ingelheim, Abdominal pain, Sustainability, ImmunoGen, RN, Bloating, CO, Providers, Glaucoma, Lead, Mirati Therapeutics, Regulatory science, AstraZeneca, HCP, Gastroesophageal reflux disease, Veeva Systems, Novartis, Omeprazole, Management, Pharmaceutical industry, Beauty salon, Generic drug, Esomeprazole, GERD

NEW YORK, May 16, 2023 /PRNewswire/ -- PM360, the premier information resource for marketing decision makers in the pharmaceutical, biotech, diagnostics, and medical device sectors, today announced the winners of its 9th Annual ELITE 100. The ELITE (Exceptional • Leaders • Innovators • Transformers • Entrepreneurs) represent the most influential people and teams in the healthcare and life sciences industries based on their career accomplishments. Out of more than 500 submissions, 100 winners are selected by the PM360 editorial staff across various categories that span every facet of the industry.

Key Points: 
  • NEW YORK, May 16, 2023 /PRNewswire/ -- PM360, the premier information resource for marketing decision makers in the pharmaceutical, biotech, diagnostics, and medical device sectors, today announced the winners of its 9th Annual ELITE 100.
  • Out of more than 500 submissions, 100 winners are selected by the PM360 editorial staff across various categories that span every facet of the industry.
  • PM360 also selects one person as the "Uber ELITE," or the individual among the nominees who best personifies the criteria of a PM360 ELITE.
  • McCourt will serve as the keynote speaker at the annual ELITE 100 Awards Event to celebrate this year's winners.

Processa Pharmaceuticals to Present PCS12852 Gastroparesis Results at the Digestive Disease Week 2023 Annual Meeting

Retrieved on: 
Friday, April 28, 2023
Pharming, Cancer, Gastroparesis, Regulatory science, PCSA, DDW, Patient, FDA, Safety, Pharmaceutical industry, MD

PCS12852 is a Phase 2b-ready, very potent and very selective novel 5-HT4 agonist, for which the company is exploring partnerships and other options to advance the program.

Key Points: 
  • PCS12852 is a Phase 2b-ready, very potent and very selective novel 5-HT4 agonist, for which the company is exploring partnerships and other options to advance the program.
  • Since the FDA-approved gastroparesis drugs have severe safety limitations, the fact that PCS12852 is ready to move to a Phase 2b trial given the positive safety and efficacy results in our proof-of-concept gastroparesis trial is a significant milestone.
  • The Company is diligently exploring strategies to advance or monetize the program.
  • We look forward to a robust discussion of the data throughout the DDW conference, and to providing continued updates to our shareholders.”

NDA Partners Appoints Senior Global Regulatory Affairs Executive, Dr. Daniela Drago as Partner in the Firm

Retrieved on: 
Tuesday, April 4, 2023
CSL Vifor, RAPS, Medical school, Swiss Federal Institute of Technology, Swiss, Biozentrum University of Basel, University, Gene, Swiss Federal Institute of Aquatic Science and Technology, ETH, Biogen, CMC, Roche, George Washington University Hospital, Bausch, Regulatory science, History, Doctor of Philosophy, Associate, Bausch & Lomb, ECPM, MS, FRAPS, Partner, UCSF, Ophthalmology, School, Cell, Executive Committee, Drug development, American Society of Gene and Cell Therapy, University of Messina, Regulatory affairs, George Washington University, Neurology, Pharmaceutical medicine, Society, Pharmaceutical industry, Medicine, Chemistry

WASHINGTON, April 4, 2023 /PRNewswire-PRWeb/ -- NDA Partners' Vice President and General Manager, Eric Fish, announced today that Dr. Daniela Drago, a senior global regulatory affairs executive, has been appointed as Partner in the firm. Dr. Drago first worked as an Expert Consultant with NDA Partners in 2014 and formerly held senior global regulatory and medical affairs positions at Biogen, Roche, Vifor Pharma, Reckitt Benckiser, Aurion Biotech, and Bausch & Lomb.

Key Points: 
  • NDA Partners' Vice President and General Manager, Eric Fish, announced today that Dr. Daniela Drago, a senior global regulatory affairs executive, has been appointed as Partner in the firm.
  • Dr. Drago first worked as an Expert Consultant with NDA Partners in 2014 and formerly held senior global regulatory and medical affairs positions at Biogen, Roche, Vifor Pharma, Reckitt Benckiser, Aurion Biotech, and Bausch & Lomb.
  • WASHINGTON, April 4, 2023 /PRNewswire-PRWeb/ -- NDA Partners' Vice President and General Manager, Eric Fish, announced today that Dr. Daniela Drago , a senior global regulatory affairs executive, has been appointed as Partner in the firm.
  • Dr. Drago is a CMC and global regulatory affairs executive with a history of accomplishments spanning pharmaceutical, biotech, and academic roles.