Who We Are
EMA Solutions includes the following experts
Dr Gonzalo Calvo:
ex-CHMP member, Clinical Assessor AEMPS, Spain
Dr Panos Tsintis:
ex-Head of Safety, EMA and Pharmacovigilance, MHRA, UK
Dr Laura Millichamp:
ex-Quality Assessor, MHRA, UK
Dr Karl-Heinz Huemer:
ex-PDCO member, EMA SAWP Member, Austria
Dr Marco Antonio Moreno:
ex-Quality Assessor, AEMPS, Spain
EMA Solutions provides a unique platform of EU Regulatory and Scientific Experts with the aim of preparing and helping sponsors prepare for interactions with EMA Committees and National Competent Authorities alike. The team of experts at EMA Solutions is comprised of ex-CHMP and other EMA Committee members (PDCO, PRAC, COMP, SAWP etc) as well as National Competent Authority Assessors. Our experts are selected on a project-by-project basis responding to client needs and integrate into the Kinesys Project Team to provide a streamlined support to our clients. We have many years of direct experience providing support for key Agency engagements such as Oral Explanations (OE) at EMA Committees, EMA and Commission Referral Procedures and SAGs, as well as other key Agency engagements. For all such engagements it is essential to have the right scientific/medical expertise and regulatory support, to have a clear and concise communication strategy, and to be prepared for the meeting room dynamics at EMA facilities.
At EMA Solutions we believe that it is not only important to have the right technical content, but also to convey your message effectively. Therefore, our service includes setting up and managing mock Agency meetings, with our ex Assessors acting as the Agency representatives. Through clear and effective communication, our dissemination strategy helps you to reap the full rewards from the work required to generate the optimum technical content for an Agency engagement. This integrated approach is designed to give our clients the best chance of success at these critical timepoints.
Other Activities
EMA Solutions’ Experts also conduct Independent Scientific Advice assessments for clients when time, resources or other issues make approaching EMA or national agencies difficult. This can also be done on an ad hoc basis. Similar to the mock OEs and other critical Agency engagements, our Experts work closely with the Kinesys Project Team members.
Similarly, Kinesys can bring in EMA Solutions Experts to assist with other key aspects of regulatory procedures such as Orphan Drug Designations, Paediatric Investigational Plans, Expedited Pathway Assessments (e.g. EU PRIME, UK ILAP, US Breakthrough Therapy, Fast Track Applications) and general development strategy and study designs.
Our Unique Offering
EMA Solutions provides an extensive, profound, added value experience in managing OEs, Referrals, SAGs and other regulatory applications and procedures at critical timepoints.
We have an impressive network of former regulators and senior level industry executives, who together can provide a unique insight into EMA / CHMP and National Competent Authority expectations.
Our combined experience of working on “both sides” of MAA submissions – industry and agency – means that we can help clients tailor their written and oral submissions and communication with Regulatory Agencies in an optimum fashion in order to reduce risk and ensure the greatest possibility of success.
Through Kinesys, EMA Solutions guarantees the greatest level of professionalism together with the highest scientific and regulatory standards. Our many and varied successful projects with major Pharma and Biotech companies, who frequently come back to us for additional support, testifies to this.