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SAN DIEGO – February 1, 2017 – Leaders from SynteractHCR, a full-service, international contract research organization (CRO), will participate in several speaking engagements and presentations at drug and device development conferences this winter. They will speak alongside other thought leaders in the clinical research industry at DIA Regulatory Submissions, Information, and Document Management Forum on February 6 – 8; Outsourcing Clinical Trials West Coast on February 22 - 23 and Outsourcing Clinical Trials Southeast on March 21 – 22.
Thomas Christensen, Senior Regulatory Affairs Manager at SynteractHCR, RAC (Regulatory Affairs Certification) will discuss “Lessons Learned for First Time OPDP Submissions, Promotional Material, and Labeling” on Tuesday, February 7 at 10:30 a.m. – noon in Track 4: ERS at DIA Regulatory Submissions, Information, and Document Management Forum, being held at the Bethesda North Marriott Hotel and Conference Center. Christensen will offer insights on submitting Electronic Common Technical Documents (eCTDs) for drugs and biologics advertising and promotional submissions, set to go into effect in May 2017 in the U.S. He will discuss working with the FDA, guidelines for preparing Form 2253 and XML attributes required in submissions to The Office of Prescription Drug Promotion and the Advertising and Promotional Labeling Branch at the FDA.
Erin Parker, senior director, Global Medical Operations at SynteractHCR will speak on “Key Considerations for Selecting a Safety Services Provider” on Wednesday, February 22 at 11:30 a.m. at Outsourcing Clinical Trials West Coast in Burlingame, California and again on Tuesday, March 21 at 12 noon at Outsourcing Clinical Trials Southeast in Cary, North Carolina. She will discuss important factors to consider in partnering with an outsourcing vendor to address safety needs throughout the product development lifecycle, from Phases I through IV. Additionally, she will offer potential benefits and pitfalls and provide specific case study examples on how to best partner with a CRO.
SynteractHCR is a full-service contract research organization with a successful two-decade track record supporting biotechnology, medical device and pharmaceutical companies in all phases of clinical development. SynteractHCR has conducted Phase I-IV studies on six continents and 60 countries, offering expertise across multiple therapeutic areas, with notable depth in oncology, immunotherapy, CNS, infectious disease, endocrinology, cardiovascular and respiratory, among other indications. With its “Shared Work – Shared Vision” philosophy, SynteractHCR provides customized services collaboratively and cost effectively, ensuring on-time delivery of quality data to help bring tomorrow’s treatments to patients.
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