Press release
Drug Safety Alliance Quality and Regulatory Affairs Leader Earns International Certification
Regulatory Affairs Professionals Society Awards Canadian RAC Distinction to Joe Knight-McKenna(Research Triangle Park, N.C.) Drug Safety Alliance (DSA), a global leader in pharmaceutical safety and pharmacovigilance, is proud to announce that Senior Director, Quality and Regulatory Affairs, Joe Knight-McKenna has earned the Regulatory Affairs Certification, Canadian RAC (CAN) distinction.
The certification was awarded to Knight-McKenna (MBA, CQM/OE, CQA, CSQE, RAC/CAN) by the Regulatory Affairs Professionals Society (RAPS) and its Regulatory Affairs Certification Board in late 2008. Knight-McKenna works at Drug Safety Alliance to ensure that regulatory reporting requirements are met for all clients to governing agencies all over the globe and that the quality of this data is very high.
“Regulatory compliance and quality control are essential considerations in today’s pharmaceutical industry worldwide. They require constant diligence and training to keep up with changes to avoid fines and other assorted disruptions to drug development,” said Cathy Stokes, president and CEO of Drug Safety Alliance. She added that industry leaders like Knight-McKenna who pursue continuing education in areas such as regulatory affairs make the industry stronger by sharing their knowledge with clients and peers.
Knight-McKenna, who presented on quality assurance protocols in Europe at this past Fall’s RAPS conference in Boston, earned this new certification by performing well on a comprehensive examination on Canadian regulations, laws, guidelines, and policies dealing with medical devices, biologics and drugs. Pursuit of the RAPS certification is voluntary. , The certification program, which was implemented in 1990 by RAPS, is designed to elevate professional standards, distinguish individuals demonstrating knowledge essential to regulatory affairs, and enhance individual performance.
“As more companies are utilizing Canada for performing clinical trials as well as marketing their products, it is important for DSA to demonstrate to our clients that we have a profound knowledge of the Canadian regulatory environment,” Knight-McKenna said, adding, “Understanding the Canadian regulatory environment, along with the US and EU’s, enables us to offer comprehensive global pharmacovigilance services.”
Knight-McKenna is responsible for Drug Safety Alliance’s quality management system, regulatory compliance and inspection readiness programs. In addition to his recent Canadian certification, Knight-McKenna has been RAC-certified for the United States since 1999 and for the European Union (EU) since 2003.
About Drug Safety Alliance
Founded in 2000, Drug Safety Alliance (DSA) provides pharmacovigilance expertise to large and small pharmaceutical and biotechnology companies to help them develop safe drugs and improve patient safety. DSA's mission is to partner with clients to mitigate their drug safety risks and to maximize product longevity and value. Driven by the highest ethical standards, DSA is uniquely focused to provide high-quality pre- and post-market drug safety services including domestic and international regulatory compliance, safety database support and hosting options, risk management and adverse event case management. DSA is headquartered in the Research Triangle Park region of North Carolina with strategic partnerships worldwide. For more information please visit www.DrugSafetyAlliance.com.
Media Contact:
David Menzies
Menzies Consulting, Inc.
(for Drug Safety Alliance)
dmenzies@menziesconsulting.com
(919) 274-6862
Drug Safety Alliance
Deena Wegner
919-401-8003
This release was published on openPR.
Permanent link to this press release:
Copy
Please set a link in the press area of your homepage to this press release on openPR. openPR disclaims liability for any content contained in this release.
You can edit or delete your press release Drug Safety Alliance Quality and Regulatory Affairs Leader Earns International Certification here
News-ID: 64790 • Views: …
More Releases from Drug Safety Alliance
Drug Safety Alliance Advocates Proactive Signal Detection
Product Life-Cycle Signal Management Can Help Pharmaceutical Companies Protect Public Health and Product Assets
(Research Triangle Park, N.C.) Drug Safety Alliance (DSA) -- a global leader in pharmaceutical safety and pharmacovigilance -- offered details at the recent Seventh Annual International Users Conference in San Francisco, CA on how a well-designed signal management program and select tools can help pharmaceutical companies with early detection of new safety information.
In her session, "Pragmatic…
Drug Safety Alliance Announces Pharmacovigilance Upgrades
Information Technology Improvements Support Implementation of Enhanced Adverse Event Reporting Software
(Research Triangle Park, N.C.) - October 30, 2008 -- Drug Safety Alliance (DSA), a global leader in pharmaceutical safety and pharmacovigilance, today announced major hardware and software upgrades to support the implementation of the new Empirica (TM) Trace adverse event reporting software. The announcement was made as DSA Chief Information Officer Doug Hill presented a case study on the upgrade…
National Organization Seeks Drug Safety Alliance’s Expertise
Pharmaceutical Safety Company Shares Insight into European Quality Assurance Regulations
(Research Triangle Park, N.C.) – October 7, 2008 -- Drug Safety Alliance (DSA), a global leader in pharmaceutical safety and pharmacovigilance, was invited to share their extensive insight into quality assurance protocols in Europe with the Regulatory Affairs Professionals Society (RAPS) at their annual conference held recently in Boston.
Conference presenter Joseph Knight-McKenna (MBA, CQM/OE, CQA, CSQE, RAC), DSA’s senior director,…
More Releases for Regulatory
Medical Device Regulatory Affairs Market Medical Device Regulatory Affairs Marke …
"Medical Device Regulatory Affairs Market" in terms of revenue was estimated to be worth $ 6.7 billion in 2024 and is poised to reach $ 18.3 billion by 2034, growing at a CAGR of 10.8% from 2025 to 2034 according to a new report by InsightAce Analytic.
Request For Free Sample Pages:
https://www.insightaceanalytic.com/request-sample/1913
Latest Drivers Restraint and Opportunities Market Snapshot:
Key factors influencing the global medical device regulatory…
Medical Device & IVD Regulatory Affairs Outsourcing Market: Navigating Regulator …
Global healthcare landscape, the Medical Device & IVD Regulatory Affairs Outsourcing Market has emerged as a critical component ensuring the safe and compliant introduction of medical devices and in-vitro diagnostic products to the market. As the industry witnesses significant shifts and challenges, here's an in-depth analysis of the current trends, dynamics, and future prospects within this market segment.
Download sample PDF copy of report: https://www.transparencymarketresearch.com/sample/sample.php?flag=S&rep_id=79264&utm_source=OpenPR_Ajay&utm_medium=OpenPR
Impact of COVID-19 on European Regulations
The outbreak of…
Regulatory Writing Market - Clear, Concise, Compliant: Redefining Regulatory Wri …
Newark, New Castle, USA - new report, titled Regulatory Writing Market The report has been put together using primary and secondary research methodologies, which offer an accurate and precise understanding of the Regulatory Writing market. Analysts have used a top-down and bottom-up approach to evaluate the segments and provide a fair assessment of their impact on the global Regulatory Writing market. The report offers an overview of the market, which…
Complex Regulatory Frameworks
It is challenging for new entrants to enter the FinTech industry because of its complex regulatory framework. All FinTech companies must comply with compliance requirements even before they begin operations, which increases their costs and creates a significant barrier for startups. While regulations are needed to protect consumers, a number of existing laws are slowing down the growth of many Indian FinTech companies, thereby extending their time to reach the…
South Africa Upstream Fiscal and Regulatory Report 2017 - Pending Legislation Cr …
Presented report, South Africa Upstream Fiscal and Regulatory Report 2017 - Pending Legislation Creates Regulatory Uncertainty, presents the essential information relating to the terms which govern investment into South Africa’s upstream oil and gas sector. The report sets out in detail the contractual framework under which firms must operate in the industry, clearly defining factors affecting profitability and quantifying the state’s take from hydrocarbon production. Considering political, economic and industry…
Regulatory Affairs Outsourcing Market (Services - Regulatory Submissions, Clinic …
This research study analyzes the market for regulatory affairs outsourcing services in terms of revenue (US$ Mn). The stakeholders of this report comprises the clinical research organizations. The global regulatory affairs outsourcing market has been broadly segmented on the basis of services (Regulatory Submissions, Clinical Trial Applications and Product Registrations, Regulatory Writing and Publishing, Regulatory Consulting and Legal Representation and others regulatory affairs, and Geography (North America, Europe, Asia Pacific,…
