The Summer School on Pharmaceutical Analysis (SSPA) addresses the most advanced analytical methodologies involved in the development of new drugs and in drug manufacturing. The ultimate goal of a drug discovery program is to generate a candidate drug compound that, besides being active and selective, is safe and efficacious in humans. In order to develop such a compound, many criteria including affinity, activity, selectivity, physico-chemical properties, and pharmacokinetics must be optimized. The definition of these criteria involves the availability and knowledge of appropriate analytical methodologies.
Each SSPA edition is focused on a specific aspect/phase of the drug discovery process. In detail, the 2023 edition of SSPA will focus on Analytical methods for drug manufacturing and quality control and will feature the following main subjects.
Pharmacopeias, Guidelines, GMP regulation et al.
Structural Analytical Chemistry: NMR, spectroscopy
Analytical aspects related to API development and manufacturing
Analytical aspects related to Drug Product development and manufacturing
In Process Control & Cleaning Verification
Analytical Method Development and Phase-Appropriate Method Validation
Analytical Aspects for Inhalation products
Physical Properties and Solid State Characterization
Stability Studies
Microbiology Testing and Environmental monitoring
Case studies: eparine and nitrosamine
Lectures will be delivered by recognized experts from the academic and industrial sectors. A list of confirmed lecturers is available at the section “meet our speakers”. The School social activities are planned to promote networking and favor interactivity between participants and lecturers. To maximize these aspects the number of participants in presence is limited to 80.
We are working to make SSPA2023 a great opportunity for enforcing your scientific competitiveness but also an enjoyable and friendly experience.
We are looking forward to welcoming you in Rimini.
Manuela Bartolini
Chair of SSPA
Department of Pharmacy and Biotechnology, Alma Mater Studiorum University of Bologna
Rimini (IT)
11th-13th Sept 2023
14 Drug Discovery Professionals
80 Students
The ultimate goal of a drug discovery program is to generate a candidate drug compound that, besides being active and selective in vitro on the isolated target, is safe and efficacious in humans. In order to develop such a compound, many criteria including affinity, activity, selectivity, physico-chemical properties, and pharmacokinetics must be optimized. The definition of these criteria involves the availability and knowledge of appropriate bio-analytical methodologies.
The SSPA2023 is housed in Campus di Rimini, aula Briolini, Palazzo Ruffi-Briolini, Corso d’Augusto 237, Rimini. Venue location is mapped here below. The school venue is conveniently located at a walking distance from the rail station and in Rimini city center.
Debora has a BS Chemical and Pharmaceutical Technology and a PhD in Chemistry at the University of Florence. She works in the past as post- doctoral position at the ICMUB in Dijon and Ecole Normal Superieur in Paris. She worked in the academia to develop new drug for cancer. She joined Thermo in 2012 as HPLC specialist for biopharma and then move to GC-GCMS application specialist.
In 2016 she joined the group of LSMS South as support scientist in food and environmental pharma laboratory.
Since 2021 she is managing the team of Application Scientist of Applied Market and Pharma in Italy and Northern Europe
Matteo has a strong background in the solid state characterization of organic and inorganic materials with expert understanding of the implications connected to the process of solid state profile determination in the pharmaceutical industry. His major responsibilities focus on crystalline structure elucidation, API form/version selection, drug developability, regulatory compliance.
His career started with working experiences in various European organizations prior to joining GlaxoSmithKline in 2006. In 2012 he became technical project leader in the Material Science space. In 2018 he took the full responsibility as a Manager of the Physical Properties & Preformulation Unit at Aptuit in Verona (Italy).
Matteo is currently covering the global role of Material Science Scientific Leader, supporting the Discovery & Development Lines in delivering outstanding scientific output for projects and customer satisfaction, playing a transversal role for ensuring continued matrix support to the company.
He is a Research Expert in the Analytical Project Leaders and Stability group of Aptuit (Evotec company) in Verona (Italy). Arnaud obtained his Bachelor of Science (BSc) Hons in Chemistry at the Nottingham Trent University in Nottingham, UK. About fifteen years of experience in the analytical field accountable for the oversight of analytical activities to support API / DP development and manufacture mainly for early Phase I/II clinical trials. As project lead, he is responsible to support the API development process from analytical methods development / validation to setting specification limits for Starting materials, Intermediates, and final Drug substance, forced degradation studies, in parallel with formulation development activities such as excipient compatibility, prototypes DOE and informal stress stability studies; reviewing experiments, data trending to meet CQA and agreed timelines. He is involved in the preparation of regulatory documents (IND, CTA). Prior to joining Evotec, previous experience included laboratory positions in analytical and formulation development for Inhaled drug products in leading global CRO / Pharmaceutical companies in the United Kingdom and the Republic of Ireland.
Graduated in CTF at the University of Naples Federico II, he has been working in Chiesi Farmaceutici S.p.A. for 9 years.
He began his work experience as a chemical laboratory technician by performing chemical-physical analyzes on raw materials, semi-finished products, finished products and stability.
He holds the position of Analytical Scientist and Sampling, Cleaning & Device/Packaging management Team Head in R&D where he monitors the analytical activities for the release of pharmaceutical products and is involved in the design of documentation and in the coordination of activities related to the development, validation and transfer of analytical methods, with a focus on cleaning methods.
Furthermore, he manages the sampling activities as well as the archiving of reference the related areas
I studied pharmaceutical Chemistry at University of Milan and joined the research group of Prof. B. Casu at the Istituto G. Ronzoni in 1988. Since 2022, as the Director of Ronzoni Institute, I am responsible of the scientific direction and the economic control of the Foundation. I am a leading expert in the field of chemistry/biochemistry of heparin and heparan sulfate and I devoted my scientific activities to the elucidation of relationships between structure, biological activity and applied properties of oligo- and polysaccharides. My group has given especially important contributions to the advancement of analytical methods for the characterization of glycosaminoglycans and other complex drugs. I have authored more than 140 publications in scientific peer-reviewed journals.
She is a Senior Supervisor in the Analytical Project Leaders and Stability group of Aptuit (Evotec company) in Verona (Italy). Martina obtained his master's degree (MSc) in Chemistry and Pharmaceutical Technologies (CTF) at the University of Modena e Reggio Emilia in Modena, Italy. Since 2017 she is leading a team with the main responsibility to conduct informal stress stability studies during development mainly for prototype selection and packaging screening and to conduct formal ICH-like stability studies on technical and clinical batches to generate data for end-of-life specification setting, retest period / shelf-life assignment and regulatory submission support during Clinical Phases and Registration. About nine years of experience in the analytical field to support development, manufacture, and quality control of API/DP for small molecules.
Dr. Francesca Luciani is the Coordinator of the Biotechnologicals Section at the National Center for the control and evaluation of Medicines, managing the analytical control of Biotech Medicinal Products. She is expert of manufacturing and analytical control of Biotech Medicinal Product and quality assessor of MAA for biotech products. She is the Italian Member of the CHMP Biologics Working Party (BWP) at EMA on behalf of the Italian Medicines Agency. She is GMP inspector and works as Expert of the P4Bio and MAB Working Parties of the European Pharmacopoiea, dealing with the development of analytical standards and the drafting of texts and monographs for recombinant proteins and monoclonal antibodies.
Since 2004, I am involved in the quality control of Biological and Biotechnological products: Batch release of Human Immunoglobulins, MenB Vaccine and Plasma Pool Testing for viral markers within the EU-Official Medicine Control Laboratory Network; Post-marketing surveillance at National and European level of Immunoglobulins, Vaccines, Biological and Biotechnological products; Participation in Biological Standardization Programme (BSP) for the establishment of new Reference Standards; Development of new/alternative test methods in the context of the European Pharmacopeia and Official Control Authority Batch Release activity; Assessor for Biological and Biotechnological products at National (AIFA) and European (EMA) level; Member of Group 6 (Biological and Biotechnological products) of the European Pharmacopoeia;
In addition: Senior GMP Inspector (AIFA)
Degree in Chemistry (Padova). He has more than 20 years of experience in the analytical chemistry in active pharmaceutical ingredients (API) manufacturing environment. He started in cGMP quality control as a QC analyst and then as R&D analyst in analytical development department. Since 2010 he followed as responsible of the analytical development the manufacturing of API (small molecules) from lab to commercial scale developing and testing all analytical methods suitable for the quality assessment of the substance. Expertise in all common instrumentation used in pharma environment, he ensures the analytical development strategy, robustness tests, analytical validations and technical transfers in all cGMP aspects especially in impurity profiling.
She graduated in Pharmaceutical Chemistry and Technology at the University of Milan in March 2008.
After short experiences in galenics production in pharmacies and in the quality control lab of a company, she joined Bruker Italia in the same year, as a member of the application team of the Nuclear Magnetic Resonance division.
He mainly works in the field of metabolomics and analysis of complex mixtures, dealing with targeted analysis and statistical analysis of data, starting with biological matrices, then specialising in food matrices and providing support and training to customers
I have a Ph.D in Drugs, Biomolecules and Health Products achieved at University of Parma where I'd worked in the development of new carriers for dry powder inhalers. During my PhD I also had the opportunity to work at Research Center of Pharmaceutical Engineering GmbH in Graz, Austria. After a short period in Aptuit, Verona where I'd worked as research scientist, I'd joined Chiesi Farmaceutici in 2018 where I'm involved as lead analytical scientist, for the department of Global technical development, in the development from phase I to the market of orally inhaled and solid oral drug products.
Please fill in the on-line registration form here and send a copy of the bank transfert by email to the SSPA2023 Secretariat at secretariat@sspaweb.com. Your registration will be confirmed only upon reception of the Proof of Payment.
Participants to the SSPA2023 can choose between three registration packages: an All Inclusive Registration (attendance in presence), a Basic Registration (attendance in presence) and a Virtual ticket (virtual meeting).
Registration policy and fees All registrations will be accepted until August 29, 2023. After this date, only basic and virtual will be accepted. Registration will close on September 6th, 2023.
GDPR The personal information we receive from participants will also be required after the School for statistical purposes and for the dispatch of information on relevant symposia/school in the future. If you do not wish your personal data to be published or distributed, please inform us when you register for the summer school.
Confirmation An e-mail confirming your registration will be sent to you upon reception of a pdf proof of bank trasnfer.
Cancellation must be submitted in writing to the SSPA 2022 Secretariat (secretariat@sspaweb.com). The policy regarding refund of the registration fee is as follows: For all inclusive registrations, cancellations received before August 29th, 2023 will not be charged by any fee but bank fee will be deducted. After August 29th, 2023 no refund will be made. For basic and virtual registrations, for cancellations received before September 6th, 2023 there will not be a cancellation charge (bank fee shall be deducted). After September 6th, 2023 no refund will be made.
Payment All payments should be made in Euro by bank transfer to:
Account holder: Società Chimica Italiana-SSPA
Bank address: DEUTSCHE BANK MILANO C 463, VIALE GIUSTINIANO 1
Iban Code: IT50N0310401603000000821734
Swift Code: DEUT IT M1463
Remittance have to be free of any bank charges to the organizers.
For extra-EU partecipants having troubles with payment by bank transfer a payment by credit card can be arranged upon request. To have it arranged please contact the SSPA2023 secretariat at secretariat@sspaweb.com
Proof of Payment must be submitted by e-mail (secretariat@sspaweb.com) at the time of registration. Please ensure that the name and company/University of each delegate is printed clearly to ensure that the payment will be correctly registered. The payment receipt and the attendance certificate will be sent to the participant by email at the completion of the School.
Insurance The Organizing Committee cannot accept any liability. Participants should make their own arrangements with respect to health and travel insurance.
The Divisione di Chimica Farmaceutica of the Società Chimica Italiana (Italian Chemical Society) grants 3 fellowships for the participation to SSPA2023. Fellowships, covering the registration fee and accommodation (twin room), are reserved to young members of the Divisione di Chimica Farmaceutica with no permanent position at their institution (PhD students, graduated fellows and post-doctoral fellows, RTDa, volunteers or young researchers from other public research bodies), born after 30 April 1988.
Applicants are invited to fill in the on line format and submit a brief description of their research project (max 1 page in A4 format including project title, font size 11 pt, max 4000 characters including spaces) and a supporting letter by the applicant’s mentor stating the candidate position, within 30th April 2023.
For further details click here (in Italian).
To submit your application please fill this form.
Italian and foreign Ph.D. students in the end phase of their Ph.D. project are kindly invited to orally present their work (20 minutes including discussion). Abstracts will be evaluated by the scientific committee prior acceptance. In the case the number of candidate presentations exceeds the number that can be accommodated in the program, a selection will be made on the basis of novelty, pertinence, and clarity. Abstracts for Ph.D. oral presentations must be submitted before June 7, 2023, according to the template given here.
The PhD students whose abstract has been accepted must complete their registration within the early registration date to have their presentation confirmed.
SSPA Secretariat
Marina Naldi
Department of Pharmacy and Biotechnology
Alma Mater Studiorum University of Bologna
Via Belmeloro 6
40126 Bologna, Italy
(+39).051.20.99.707
secretariat@sspaweb.com
SSPA Director
Manuela Bartolini
Department of Pharmacy and Biotechnology
Alma Mater Studiorum University of Bologna
Via Belmeloro 6
40126 Bologna, Italy
(+39).051.20.99.704
manuela.bartolini3@unibo.it
