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A young woman from India who earned her MS in Pharmacology in the USA in 2009, since my graduation I have been working here in the USA as a research scientist for the pharmaceutical industry. Now that I have extensive experience in this area and I have put my first Master’s Degree to work professionally for a half decade, I feel strongly that the best way for me to advance in my career and achieve my long term goals is to earn a second, highly complementary, Master’s Degree. Thus, I am writing in behalf of my application to your especially distinguished MS Program in Regulatory Science at the University of XXXX so that I might broaden my professional potential to make important contributions to the search for bio-similar compounds that could help to decrease the cost of effective pharmaceutical products. I appreciate very much the leadership role of the FDA in this promising research and I have my sights set on the goal of working for this organization in the future.

Heroines of Regulatory Science, Affairs

There are some cool girls with their fingers in the regulatory pie who are doing great things. Here are some of them described on the right.

Lynn Farrell co-leads the Regulatory Compliance consulting practice at Treliant Risk Advisors, LLC—a Washington DC-based risk management consultancy.  She leads a team of professionals at a strategic compliance consulting practice that serves many of the top 100 financial institutions. Farrell is a Certified Regulatory Compliance Manager (CRCM), a Certified Anti-Money Laundering Specialist (CAMS) and an Anti-Money Laundering Professional (AMLP). Farrell also received the Distinguished Service Award from the American Bankers Association in 2012.  She is also a licensed attorney. Lyn has led many diverse and complex compliance projects for large financial institutions.  Farrell received her undergraduate degree from Texas A&M University and her JD from the University of Houston.

Beate R. Schmidt, MSc, MDRA, RAC

Beate Schmidt is an accomplished regulatory professional with more than 18 years of in-depth experience in the development and licensing of innovative and follow-on medicinal products. Schmitt is a biologist by training (MSc from Heidelberg University, Germany).  Her professional education also includes a postgraduate Master’s degree in Drug Regulatory Affairs from the University of Bonn (Germany) as well as the Regulatory Affairs Certification (RAC) for the US and the EU from the Regulatory Affairs Professionals Society (RAPS). Her post-graduate master’s degree was earned in in Health Economics, Policy and Management from the London School of Economics (LSE) as well as Market Access Manager (EBS) from the European Business School (Oestrich-Winkel, Germany).

Schmidt has served in various executive positions in the global biotechnology and pharmaceutical industry including Associate Director, Regulatory Affairs at Aspreva Pharmaceuticals Corp. (Victoria, BC, Canada) and Director, Regulatory Affairs at Micromet AG (Munich, Germany).She worked as a scientific administrator in the Safety and Efficacy of Medicines sector of the European Medicines Agency (EMA) in London from 2009 to 2012, with responsibility, as a Product Team Leader, for the coordination of diverse regulatory procedures – from initial marketing authorisation applications to life-cycle management – for a broad range of leading-edge and follow-on products. Schmidt’s therapeutic area experience includes oncology/haematology, rheumatology and autoimmune disorders, immunological and transplant indications as well as blood products.

She has completed extensive practical work experience in Europe and North America (Canada, US). She also did an internship at the German Federal Joint Committee (Gemeinsamer Bundesausschuß, G-BA) in Berlin in 2012. Schmidt is now a freelance regulatory consultant to the pharmaceutical and biotechnology industry as of 2012.

Leslie Ball, M.D.

Leslie Ball has worked as Assistant Commissioner of International Programs and Deputy Director of FDA’s Office of International Programs since September 2012. The Office of International Programs leads FDA’s international activities and oversees the operation of FDA’s thirteen regional and country offices. Prior to this position, Dr. Ball served as Acting Director of the Office of Scientific Investigations, and as Director of the Division of Scientific Investigations, Office of Compliance, CDER, FDA before that. While in the Division of Scientific Investigations, she played a role in developing a risk model for selecting clinical trial sites for inspection, collaborating with EMA and other international regulatory authorities, developing approaches to inspecting electronic data, and instituting process improvements for enforcement actions.

Dr. Ball graduated with a B.S. in biology from Georgetown University. She also received her M.D. and completed a residency in pediatrics at the same institution. Dr. Ball completed a Fellowship in pediatric infectious diseases at the Walter Reed Army Medical Center. Dr. Ball served as a practicing pediatrician at the U.S. Naval Hospital, Subic Bay, Republic of the Philippines, in private practice in Maryland, at the National Naval Medical Center, Bethesda.

Martha A. Brumfield, Ph.D.,

Martha Brumfield is Director of International and Regulatory Programs at C-Path. Dr. Brumfield has a consulting practice focusing on concordance in global regulatory initiatives; examining regulatory science qualification programs; and providing educational workshops on these and related topics.

Other areas of focus include excellence in clinical trial conduct and programs supporting patient access to medicines, but at present, she is engaged with the nonprofit C-Path as a consultant to guide international program development and to provide regulatory guidance to consortiums. Dr. Brumfield is also engaged with other nonprofits, Regulatory Harmonization Institute and GlobalMD, to deliver educational workshops on regulatory and clinical trial topics in Asia. She is leading work through C-Path to TB drug regimens in order to identify regulatory pathways in high-burden TB countries. Most recently, Dr. Brumfield was senior vice president, Worldwide Regulatory Affairs and Quality Assurance at Pfizer Inc, where she led a global team that supported lifecycle pharmaceutical research, development, and commercialization through creation and implementation of regulatory strategies and quality assurance oversight. Dr. Brumfield also played a key role in managing the broader company relationships with global regulators, trade associations, academics, and others regarding regulatory policy issues.

She has been active in several external organizations, including PhRMA, CMR, and the APEC Life Sciences Innovation Forum and has worked extensively with the PhRMA Simultaneous Global Development program. During her 20 years at Pfizer, Dr. Brumfield held a variety of leadership positions in which she led regulatory teams responsible for the U.S., Europe, and emerging markets. She also served as this company’s head of drug safety surveillance and reporting, and managed global adverse event reporting requirements and the integration of Pharmacia’s related safety operations. Dr. Brumfield earned a B.S. and M.S. in chemistry from Virginia Commonwealth University, a Ph.D. in organic chemistry from the University of Maryland, and was a postdoctoral fellow at the Rockefeller University.