Regulatory affairs

Senior Regulatory Affairs Executive, Gregory T. Bates, DVM, Joins NDA Partners as Expert Consultant

Retrieved on: 
Wednesday, July 31, 2019
Occupations, Regulatory affairs

Dr. Bates currently serves part-time roles as both Senior Vice President of Regulatory Affairs at Axial Biotherapeutics, Inc., and as Regulatory Affairs Lead at ATAI Life Sciences AG.

Key Points: 
  • Dr. Bates currently serves part-time roles as both Senior Vice President of Regulatory Affairs at Axial Biotherapeutics, Inc., and as Regulatory Affairs Lead at ATAI Life Sciences AG.
  • Prior to joining Axial and ATAI, he served as Vice President of Regulatory Affairs at Depomed, Inc. and on the senior management team of Xenoport, Inc. At XenoPort, he served as Senior Vice President of Regulatory Affairs and Quality Assurance and, prior to that, as Vice President of Regulatory Affairs.
  • Prior to XenoPort, Dr. Bates served as the Senior Director and Director of Regulatory Affairs at Pharmacyclics, Inc., where he directed regulatory affairs and coordinated communications with global regulatory agencies.
  • Services include product development and regulatory strategy, expert consulting, high-impact project teams, and contract management of client product development programs.

Former OrthoLogic Quality Assurance Director, Donna Hartzfeld, PhD, Joins NDA Partners

Retrieved on: 
Wednesday, July 24, 2019
Quality assurance, Regulatory affairs

Dr. Hartzfeld was formerly the Quality Assurance Director at OrthoLogic, where she managed quality assurance activities for a clinical-stage wound healing drug product.

Key Points: 
  • Dr. Hartzfeld was formerly the Quality Assurance Director at OrthoLogic, where she managed quality assurance activities for a clinical-stage wound healing drug product.
  • "We are very pleased to welcome Dr. Hartzfeld to NDA Partners," said Dr. Peck.
  • She is a member of the American Society of Quality, Regulatory Affairs Professional Society, and the Arizona BioIndustry Association.
  • Services include product development and regulatory strategy, expert consulting, high-impact project teams, and contract management of client product development programs.

CTD Appoints Head of Global Regulatory Affairs

Retrieved on: 
Monday, July 8, 2019
Biotechnology, Health, Pharmaceutical, Clinical trials, Companies, Articles, Business, CAC 40, Sanofi, Regulatory affairs, Pfizer, Accenture, Pharmaceutical industry, OTC Markets Group

CTD Holdings, Inc. (OTCQB: CTDH), a clinical stage biotechnology company that develops cyclodextrin-based products for the treatment of disease with unmet medical need, today announced the appointment of Mr. Michael Lisjak as Global Head of Regulatory Affairs and Senior Vice President for Business Development.

Key Points: 
  • CTD Holdings, Inc. (OTCQB: CTDH), a clinical stage biotechnology company that develops cyclodextrin-based products for the treatment of disease with unmet medical need, today announced the appointment of Mr. Michael Lisjak as Global Head of Regulatory Affairs and Senior Vice President for Business Development.
  • Mr. Lisjak brings over 20 years of experience in global regulatory strategy and operations within the pharmaceutical industry.
  • He served most recently at Sanofi where over the past 4 years he held the positions of Head of Global Regulatory Affairs for Established Products and Global Health, and previously as the Director, Global Regulatory Affairs for the Endocrinology and Lysosomal Storage Disorders Rare Disease areas.
  • Prior to Sanofi, Mr. Lisjak served as the Global Regulatory Services Lead at Accenture, and at Pfizer where he held a number of positions with increasing responsibility, including Director of Worldwide Regulatory Strategy, a position he held for 5 years.

dMed Biopharmaceutical, a next generation CRO, announced the opening of its US Regulatory Affairs office in Washington DC to build a bridge for affordable innovative drugs for US patients

Retrieved on: 
Wednesday, June 19, 2019
Articles, Life sciences, Health, Biotechnology, Pharmaceutical industry, Pharmaceuticals policy, Biopharmaceutical, Pharmacy, Contract research organization, Regulatory affairs

With this global shift in view, dMed Biopharmaceutical, a full service next-generation clinical research organization (CRO), announced the opening of its US Regulatory Affairs office to help bring affordable innovative therapies to the US market.

Key Points: 
  • With this global shift in view, dMed Biopharmaceutical, a full service next-generation clinical research organization (CRO), announced the opening of its US Regulatory Affairs office to help bring affordable innovative therapies to the US market.
  • In 2017, China enacted sweeping reforms in its regulatory system, closely aligning rules governing the world's second largest drug market with the US and Europe.
  • The result has been a dramatic increase in applications from China-based biotechs to register innovative therapies in the US.
  • dMed is led by experts in China and the US who originated from leading multinational pharma companies and regulatory agencies.

Rebecca Walker Joins Telos Partners LLC as Manager, Regulatory & Quality Affairs

Retrieved on: 
Wednesday, June 19, 2019
Telos, Regulatory affairs, Human activities, Service industries

LAKELAND, Fla., June 19, 2019 /PRNewswire-PRWeb/ -- Telos Partners, LLC is pleased to announce that Rebecca Walker has joined the company as Manager, Regulatory and Quality Affairs.

Key Points: 
  • LAKELAND, Fla., June 19, 2019 /PRNewswire-PRWeb/ -- Telos Partners, LLC is pleased to announce that Rebecca Walker has joined the company as Manager, Regulatory and Quality Affairs.
  • She comes to Telos with 10+ years of experience in the life sciences industry, most recently as Regulatory Affairs Manager for NN Inc. (formerly Paragon Medical) overseeing all aspects of Regulatory Affairs and providing lead support for their corporate quality system initiatives.
  • Together, I look forward to providing our clients with regulatory and quality strategies that confidently support their business initiatives," stated Rebecca.
  • Telos Partners, LLC specializes in supporting the commercialization of healthcare products in 3 key areas: regulatory approval, clinician adoption, and payer reimbursement.

Eiger Appoints Industry Veteran and Regulatory Affairs Expert Mark Mannebach, PhD, RPh as Vice President of Global Regulatory Affairs

Retrieved on: 
Monday, June 10, 2019
Companies, Pfizer, Health, Articles, Covidien, Mannebach, Vulkaneifel, Mallinckrodt, Mannebach, Warner–Lambert, Regulatory affairs, Parke-Davis, Pharmaceutical industry in China

Dr. Mannebach has more than 30 years of experience in the pharmaceutical industry in leadership roles including Parke-Davis, Warner Lambert, Pharmacia, Baxter, and Pfizer.

Key Points: 
  • Dr. Mannebach has more than 30 years of experience in the pharmaceutical industry in leadership roles including Parke-Davis, Warner Lambert, Pharmacia, Baxter, and Pfizer.
  • Dr. Mannebach spent most of the last decade as Vice President of Global Regulatory Affairs and as a member of the Executive Management Team at Covidien and Mallinckrodt Pharmaceuticals.
  • "Mark's global regulatory expertise and experience will strengthen our leadership team and execution.
  • Previously, Dr. Mannebach was Vice President of U.S. Regulatory Affairs and Quality Assurance at Santen Incorporated.

Regulatory Affairs for Pharmaceutical Support Staff: Overview of EU Regulatory (Regulations, Directives and Guidelines) Procedures - London, United Kingdom - September 23-24, 2019

Retrieved on: 
Thursday, June 6, 2019
Occupations, Regulatory affairs, Regulatory science

DUBLIN, June 6, 2019 /PRNewswire/ -- The "Regulatory Affairs for Support Staff" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, June 6, 2019 /PRNewswire/ -- The "Regulatory Affairs for Support Staff" conference has been added to ResearchAndMarkets.com's offering.
  • This two-day 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.
  • The course will provide a thorough grounding in the subject of regulatory affairs and enable you to perform in your role more effectively.
  • It is also suitable for those who interface with the regulatory affairs function and who provide support to the regulatory procedures and activities.

Two Day UK Seminar: Pharmaceutical Regulatory Affairs for Support Staff - Gain an Overview of EU Regulatory Procedures (London, United Kingdom - September 23-24, 2019)

Retrieved on: 
Monday, June 3, 2019
Occupations, Regulatory affairs, Articles, Health, Human activities, Clinical research, Pharmaceuticals policy, Regulatory science

DUBLIN, June 3, 2019 /PRNewswire/ -- The "Regulatory Affairs for Support Staff" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, June 3, 2019 /PRNewswire/ -- The "Regulatory Affairs for Support Staff" conference has been added to ResearchAndMarkets.com's offering.
  • This two day 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.
  • You will gain an overview of EU regulatory procedures required to register products in Europe and the regulatory activities that need to be complied with to keep products on the market.
  • It is also suitable for those who interface with the Regulatory Affairs function and who provide support to the Regulatory procedures and activities.

Two Day UK Course: Pharmaceutical Regulatory Affairs for Support Staff - London, United Kingdom - September 23-24, 2019 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, May 29, 2019
Health, Pharmaceutical, Professional services, Other Professional Services, Occupations, Regulatory affairs, Articles, Human activities, Health, Regulatory science

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 two-day 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.
  • The course will provide a thorough grounding in the subject of regulatory affairs and enable you to perform in your role more effectively.
  • It is also suitable for those who interface with the regulatory affairs function and who provide support to the regulatory procedures and activities.

Tivic Health Strengthens Executive Team, Appoints Subinoy Das, MD, Chief Medical Officer and Michael Nketiah, MBA, RAC, VP of Quality and Regulatory Affairs

Retrieved on: 
Tuesday, May 28, 2019
Occupations, Regulatory affairs, Medicine

SAN FRANCISCO, May 28, 2019 /PRNewswire/ --Tivic Health Systems today announced the expansion of its executive team with the appointments of Subinoy Das, MD as Chief Medical Officer and Michael Nketiah as Vice President of Quality and Regulatory Affairs.

Key Points: 
  • SAN FRANCISCO, May 28, 2019 /PRNewswire/ --Tivic Health Systems today announced the expansion of its executive team with the appointments of Subinoy Das, MD as Chief Medical Officer and Michael Nketiah as Vice President of Quality and Regulatory Affairs.
  • Mr. Nketiah's domestic and international experience in quality and regulatory affairs will be invaluable as we chart our growth."
  • Mr. Nketiah said, "I prefer companies that have a deep respect for and understanding of quality and have found that mindset at Tivic Health.
  • Prior to joining Tivic Health, Michael Nketiah served as VP in the areas of Quality and Regulatory for other medical technology companies such as SIRIS Medical, ClearPath Surgical Inc., and Previvo Genetics, Inc.