1000+ Sessions conducted on USFDA,EMA and APAC

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Wednesday, 29th July, 2026

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Sheila Ramerman, RAC, is the founder and Principal Consultant at SJR Associates, a medical device regulatory affairs/quality systems consulting firm with particular emphasis on near-patient testing technologies and in assisting start-up stage companies implement their regulatory, quality, and clinical studies functions. Prior to founding SJR Associates, Ms. Ramerman was responsible for regulatory affairs, quality systems, and/or clinical studies at several medical device companies in the San Francisco Bay Area. She has hands-on experience with a wide variety of medical devices, and has worked with a range of medical device companies, from start-ups to multi-national corporations. She has been Regulatory Affairs Certified (RAC) since 1998.

CLINICAL OPERATIONS Live Webinar Register Now

Saturday, 1st August, 2026

The eSTAR Submission Program

Specialties: REGULATORY AFFAIRS EU/USA, MAA/NDA/BLA/ABLA, BIOLOGICS, BIOSIMILARS, ORPHANS, Scientific Advice. Pharmaceutical and clinical development CTAs/INDs. Due deligence in/out licencing.

Hoss leads an international team of drug development Principal Consultants at his self-owned PHARMABIO CONSULTING. His experience encompasses strategic regulatory support and Due Diligence to 70 Pharma client companies from across Europe, America, Canada, China, Korea, Taiwan, Japan, and India and to the financial sector New York US and London UK.

Hoss was until 2010 Vice-President, Technical, Drug Development and Regulatory Global Strategy Services, at the leading CRO PAREXEL International. In PAREXEL CONSULTING 2000-2010 he provided a direct consulting service to more than 50 Pharma client companies Prior to this he was leading drug development programs and registrations in several international Pharma companies.

Hoss is British-Canadian educated in England to B.Sc. and PhD level, and was also a recipient of a Post-doctoral European Royal Society Fellowship award in organic chemistry. He has more than 31 years of drug development experience in over 15 therapeutic areas in the European and North American pharmaceutical industry, 21 years of which have been in regulatory affairs.

His strength is in therapeutic proteins such as novel and biosimilar monoclonal antibodies. He has substantial Orphan Drugs development experience additionally, and is applying it to niche area of orphan biosimilars. Has unique insights into the FDA-EMA requirements.

Extensive experience preparing clients for FDA meetings and has led, managed and attended across FDA meetings, in particular, formal Type B, NDA/BLA and BsUFA ABLA presubmission meetings. Highly experienced with EU: MAA presubmission EMA meetings, MAA presubmission Rapporteur/Co-rapporteur, D120 and D180 Clarification meetings SAWP/CHMP/EMA Scientific Advice.

Pioneer in European biosimilar approvals as regulatory lead to one of 2 EU Biosimilar MA hGH approvals in April 2006.

Hoss has published 5 milestone articles on biosimilars in 2012; March (US), April (EU), May (EU), May (US) and July (US), and a RAPS book biosimilars chapter in 2013, and broadcasts to US and EU monthly thought leadership professional webinars 2011-present. The latest international article in progress 2015 is on “Interchangeability among reference insulins and their biosimilars: regulatory framework, study design, and clinical implications”.

He is also a well-established international trainer (to Pharma and Agencies) and conference and webinar presenter in EU/US regulatory affairs, biologics/biosimilars, scientific advice, the Common Technical Dossier (MAA/NDA/BLA), labeling (prescriber and patient), clinical safety, pharmaceutical development, and combination drugs.