Regulatory affairs

Celegence Partners With Performance Development Group to Help Life Sciences Companies Maximize Their RIMS ROI

Retrieved on: 
Wednesday, March 13, 2019
Occupations, Regulatory affairs, Regulatory compliance

"Celegence's expertise in regulatory affairs make them an obvious choice for a partnership with Performance Development Group," says PDG's Managing Partner David Manning.

Key Points: 
  • "Celegence's expertise in regulatory affairs make them an obvious choice for a partnership with Performance Development Group," says PDG's Managing Partner David Manning.
  • Celegence and PDG will work with life sciences companies to help them maximize the ROI of their RIMS investment by ensuring that users are fully prepared to leverage their systems' benefits.
  • Celegence helps life sciences companies navigate complex global regulatory requirements by providing consulting services and solutions dedicated to regulatory affairs.
  • Celegence supports life sciences customers in the areas of regulatory intelligence, RIMS, publishing, labelling, medical writing and compliance toward new regulations for different product portfolios.

Aethlon Medical, Inc. Announces Appointment of Lisa M. Boswell as Director, Quality Systems and Regulatory Affairs

Retrieved on: 
Thursday, March 7, 2019
Pharmaceutical industry, Occupations, Regulatory affairs, Quality assurance, Medication, Quality management system, Medical device, Articles, Natural sciences, Health

SAN DIEGO, March 7, 2019 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a therapeutic medical device company focused on addressing critical unmet needs in global health, announces the appointment of Lisa M. Boswell, to the position of Director, Quality Systems and Regulatory Affairs.

Key Points: 
  • SAN DIEGO, March 7, 2019 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a therapeutic medical device company focused on addressing critical unmet needs in global health, announces the appointment of Lisa M. Boswell, to the position of Director, Quality Systems and Regulatory Affairs.
  • Ms. Boswell has over 15 years of experience in Quality Control, Quality Assurance and Regulatory Affairs in both the biopharmaceutical and medical device industries, most recently as Director, Quality Assurance and Regulatory Affairs at ZOLL Data Systems, Inc.
    "Lisa's leadership will be critical as we move the Hemopurifier through the next stages of development.
  • Prior to ZOLL, Ms. Boswell spent 10 years in positions of increasing responsibility in Quality Control at GlobeImmune, Inc. Ms. Boswell holds undergraduate degrees in Chemistry and Biology from St. Andrews Presbyterian College and an M.S.
  • The Aethlon Hemopurifier is a clinical-stage immunotherapeutic device designed to combat cancer and life-threatening viral infections.

Xynomic Pharma Doses First South Korean Patient in Phase 3 Renal Cell Carcinoma Trial and Hires Senior Executive Dr. Sophia Paspal to Head Regulatory Affairs and Quality Assurance

Retrieved on: 
Saturday, February 23, 2019
Occupations, Regulatory affairs, Human behavior, Human activities, Articles

According to US International Trade Administration, South Korea is the third largest pharmaceutical market in Asia and the 13th largest globally.

Key Points: 
  • According to US International Trade Administration, South Korea is the third largest pharmaceutical market in Asia and the 13th largest globally.
  • In addition, to support its on-going Phase 3 trial and potential submissions for new drug approval of its lead drug candidate abexinostat, Xynomic has appointed Dr. Sophia Paspalas the Vice President, Regulatory Affairs and Quality Assurance.
  • Dr. Paspal assumes overall responsibility to strengthen Xynomic's regulatory compliance and quality assurance functions.
  • From 2017 to January 2019, Dr. Paspal worked at Capricor Therapeutics, Inc. and Cellics Therapeutics, Inc., holding the same title.

2-Day Course: EU Pharmaceutical Regulations & Strategy (London, United Kingdom - April 29-30, 2019) - ResearchAndMarkets.com

Retrieved on: 
Friday, February 22, 2019
Health, Pharmaceutical, Clinical research, Health, Occupations, Regulatory affairs, Articles, Pharmaceuticals policy, Pharmaceutical industry, Regulatory Flexibility Act, Regulatory science

The "EU Pharmaceutical Regulations & Strategy" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "EU Pharmaceutical Regulations & Strategy" conference has been added to ResearchAndMarkets.com's offering.
  • This course will provide an up-to date overview of the European pharmaceutical regulatory environment, procedures and obligations.
  • It will be of value for regulatory affairs personnel and also for those who interact with regulatory personnel in order to understand action timelines and information requirements.
  • This course is for you, particularly if involved in:

AMPLEXOR Life Sciences to Showcase RIM Expertise for Driving Innovation in Regulatory Affairs at DIA Regulatory Submissions, Information, and Document Management (RISDM) Forum

Retrieved on: 
Tuesday, February 12, 2019
Health, Biotechnology, Medical devices, Pharmaceutical, Professional services, Consulting, General Health, Occupations, Regulatory affairs, Business process management, Gwyn

AMPLEXORs David Gwyn will explore what lessons can be learnt from the pharmaceutical industry to smooth such processes at the upcoming DIA Regulatory Submissions, Information, and Document Management Forum .

Key Points: 
  • AMPLEXORs David Gwyn will explore what lessons can be learnt from the pharmaceutical industry to smooth such processes at the upcoming DIA Regulatory Submissions, Information, and Document Management Forum .
  • AMPLEXOR Life Sciences will showcase how its Integral AMPLEXOR Life Sciences Suite can harmonize product, data and processes and deliver business benefit to users.
  • AMPLEXOR Life Sciences expert and Global Solutions Architect, David Gwyn will speak during Session: 10 Track: 3 focusing on Innovations in Regulatory Affairs.
  • During his presentation, Gwyn will discuss Leveraging End-to-End RIM to Drive Innovation in Regulatory Affairs.

European Handbook of Medical Devices Regulatory Affairs 2019 - ResearchAndMarkets.com

Retrieved on: 
Monday, February 11, 2019
Health, Medical devices, Occupations, Regulatory affairs, Medical device, Quality assurance, Medical equipment, Human behavior, Articles, Human activities, Medical writing

The "European Handbook of Medical Devices Regulatory Affairs 2019" directory has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "European Handbook of Medical Devices Regulatory Affairs 2019" directory has been added to ResearchAndMarkets.com's offering.
  • As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry.
  • That is why we started this Handbook for QA/RA professionals in the medical device and IVD industry.
  • Covers medical device regulatory system in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application
    The European Handbook of Medical Device Regulatory Affairs is a trusted and increasingly valuable resource.

Experienced Energy Lawyer Zev Simpser Joins Dorsey in Minneapolis

Retrieved on: 
Wednesday, February 6, 2019
Energy, Other Energy, Professional services, Legal, Dorsey & Whitney, Regulatory affairs, Regulatory compliance

View the full release here: https://www.businesswire.com/news/home/20190206005594/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20190206005594/en/
    Zeviel T. Simpser has joined Dorsey's Regulatory Affairs Group as a partner in Minneapolis.
  • (Photo: Dorsey & Whitney LLP)
    Mr. Simpser practices principally in the areas of energy law, regulatory compliance, regulatory proceedings and disputes, regulated transactions and risk management.
  • He joins Dorsey from private practice in a major Twin Cities law firm in Minneapolis where he was a shareholder.
  • Zev Simpser is a great addition to our Energy & Natural Resources Industry Group and to our Regulatory Affairs practice.

FDAnews Announces -- FDA's Plan for Modernizing the 510(k) Pathway: What Regulatory, Quality & Compliance Professionals Need to Know Webinar, Feb. 20, 2019

Retrieved on: 
Wednesday, February 6, 2019
Health, Occupations, Regulatory affairs, Medical device, Biomedical engineering, Food and Drug Administration, Articles, Human behavior

Mary Vater, medical device consultant at Medical Device Academy, Inc., will share best practices and tips for preparing and submitting 510(k)s. She'll discuss common mistakes and the FDA's current and evolving expectations for submissions.

Key Points: 
  • Mary Vater, medical device consultant at Medical Device Academy, Inc., will share best practices and tips for preparing and submitting 510(k)s. She'll discuss common mistakes and the FDA's current and evolving expectations for submissions.
  • After 90-minutes attendees will know:
    This presentation will break down the 510(k) process and let attendees know what changes can be anticipate for future submissions.
  • Mary Vater is an experienced Biomedical Engineer, now serving as a Medical Device Consultant with Medical Device Academy, Inc., specializing in Regulatory Affairs.
  • Mary started her career at a medical device contract manufacturer, wearing several hats during her time in R&D, Engineering, and Quality Assurance.

2-Day Course: Regulatory Affairs for Support Staff (London, United Kingdom - September 23-24, 2019) - ResearchAndMarkets.com

Retrieved on: 
Monday, January 28, 2019
Health, Clinical trials, Pharmaceutical, Health, Articles, Pharmaceuticals policy, Clinical research, Healthcare quality, Clinical trials, Pharmacovigilance, Pharmaceutical industry, Regulatory affairs

The "Regulatory Affairs for Support Staff" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Regulatory Affairs for Support Staff" conference has been added to ResearchAndMarkets.com's offering.
  • This course provides an introduction to Pharmaceutical Regulatory Affairs and the basics of drug development and has been designed specifically for those working in a support staff role.
  • Pharmacovigilance and safety reporting will be covered as well as license variations and the commercial aspects of Pharmaceutical products.
  • The course will provide a thorough grounding in the subject of Regulatory Affairs and enable you to perform in your role more effectively.

Global Handbook of Medical Devices Regulatory Affairs, 2019 - ResearchAndMarkets.com

Retrieved on: 
Friday, January 25, 2019
Health, Medical devices, Health, Articles, Medical statistics, Food and Drug Administration, Medical device, Regulatory affairs, Clinical trial, ISO 13485, Guidances for statistics in regulatory affairs

The "Global Handbook of Medical Devices Regulatory Affairs 2019" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Handbook of Medical Devices Regulatory Affairs 2019" report has been added to ResearchAndMarkets.com's offering.
  • Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones.
  • This Handbook is an excellent reference for understanding what is required to bring medical devices to market under the many different regulatory systems in this important region.
  • Covers medical device regulatory system in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application