SMCA (Lithuania) Management of Marketing Authorisation evaluation
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1 Curriculum vitae PERSONAL INFORMATION Valdas Liukaitis WORK EXPERIENCE February 2007 Present Head of Mutual Recognition and Decentralised Procedures Unit SMCA (Lithuania) Assessment of safety and efficacy of medicinal products in MRP DCP. Participation in CMD(h) referral procedures. November 2003 Present clinical assessor SMCA (Lithuania) Assessment of safety and efficacy of medicinal products in national priocedures Present QRD assessor EMA / SMCA (Lithuania) PI QRD assessment. September 2003 Present lector/assistant Lithuanian University of Health Sciences (Lithuania) Educational and scientific activities in Department of Theoretical and Clinical Pharmacology / Institute of Physiology and Pharmacology 2006 February 2007 Deputy head of Human Medicines Marketing Authorisation Subdivision SMCA (Lithuania) Management of Marketing Authorisation evaluation Doctor anesthesiologist-resuscitator Kaunas Medical University Hospital (Lithuania) Therapeutic activities EDUCATION AND TRAINING September 1986 June 1994 Master of Medicine, Physician Human medicine studies August 1994 July 1995 Doctor's qualification Therapeutic practice Resident doctor August 1995 July 1998 Anesthesiologist-resuscitator Resident doctor anesthesiologist-resuscitator Therapeutic practice 9/1/18 European Union, Page 1 / 6
2 July 1998 August 2002 Graduate student Scientific activities April 2003 Doctor s degree PhD Biomedical science ADDITIONAL INFORMATION Expertise Clinical assessor Assesment of Safety and eficacy of: - anesthetics, - medicinal products affecting cardiovascular system Assessment of Bioequivalence QRD assessor RMP assessor Publications 1. Sakalauskienė, Giedrė Valdonė; Liukaitis, Valdas; Milašius, Arvydas; Stankevičius, Edgaras. Autonominę nervų sistemą veikiančių vaistinių preparatų farmakodinamika ir farmakokinetika : mokomoji knyga /Giedrė Sakalauskienė... [et al.] // Kaunas : Lietuvos sveikatos mokslų universiteto leidybos namai, p. ISBN: ; UDK: (075.8) 2.Pilvinis, Vidas; Nekrašienė, Milda; Tamošuitis, Tomas; Liukaitis, Valdas; Bagajevaitė, Rūta. Terapinė hipotermija: fiziologiniai pokyčiai, komplikacijos, klinikinis pritaikymas / Vidas Pilvinis, Milda Nekrašienė,Tomas Tamošuitis, Valdas Liukaitis, Rūta Bagajavaitė // Sveikatos mokslai = Health sciences. Vilnius : Sveikata. (Apžvalga. Informacija). ISSN , t. 23, Nr. 4, p Liukaitis, Valdas; Milašius, Arvydas. Adrenoreceptoriai ir jų įtaka organizmo funkcijoms / V. Liukaitis, A. Milašius // Šokai: jų priežastys, patogenezė, klinika bei gydymas : konferencijos medžiaga : Kaunas, / Lietuvos Intensyviosios terapijos draugija ; Lietuvos sveikatos mokslų universiteto Intensyviosios terapijos klinika ; [ats. red.: Dagmara Reingardienė]. Kaunas : "Morkūnas ir Ko", ISBN p : lent. 4.Liukaitis, Valdas; Reingardienė, Dagmara Ona. Epinefrino ir norepinefrino vartojimo ypatybės ir poveikio skirtumai / V. Liukaitis, D. Reingardienė // Šokai: jų priežastys, patogenezė, klinika bei gydymas : konferencijos medžiaga : Kaunas, / Lietuvos Intensyviosios terapijos draugija ; Lietuvos sveikatos mokslų universiteto Intensyviosios terapijos klinika ; [ats. red.: Dagmara Reingardienė]. Kaunas : "Morkūnas ir Ko", ISBN p : lent. 5.Liukaitis, Valdas; Reingardienė, Dagmara Ona. Elektrokardiografiniai pokyčiai galvos smegenų patologijos atvejais, galintys imituoti ūminius koronarinius sindromus / V. Liukaitis, D. Reingardienė // Ūminių koronarinių sindromų intensyvioji terapija : konferencijos medžiaga : , Kaunas / Lietuvos intensyviosios terapijos draugija, Kauno 9/1/18 European Union, Page 2 / 6
3 medicinos universiteto Intensyviosios terapijos klinika ; [ats. redaktorė: Dagmara Reingardienė]. Kaunas : ITMC, ISBN p Aželis, Vidmantas; Balnytė, Ingrida; Banienė, Rasa; Bertulis-Čerkelis, Algis Povilas; Biržietis, Tomas; Bradulskis, Saulius; Budnikas, Vytautas; Bulatov, Aleksandr; Burkauskienė, Aušra; Burneckienė, Jūratė Marija; Civinskienė, Genuvaitė; Čerkašina, Aldona; Čižauskas, Arvydas; Dabužinskienė, Anita; Daubaras, Virmantas; Daukša, Kazys; Gailienė, Greta; Gailys, Romualdas; Gedrimas, Vytautas Leonas; Giedrimas, Voldemaras; Gleiznienė, Rymantė; Gudinavičienė, Inga; Hofmanas, Alfredas; Ivanovienė, Laima; Jančiauskas, Dainius; Jankauskienė, Konstancija; Jankūnas, Rimas Jonas; Janulaitytė-Gunther, Daiva; Januškevičius, Vidmantas; Juočas, Juozas; Jurkštienė, Vilma; Kalesinskas, Romas Jonas; Kareivienė, Violeta; Kėvelaitis, Egidijus; Kirikova, Liudmila; Kiudelienė, Živilė; Kondrotas, Anatolijus Juozas; Korotkich, Igor; Kutkevičius, Juozas; Lasienė, Kristina; Laukevičienė, Alė; Lažauskas, Robertas; Leišytė, Palmyra; Lekauskaitė, Aušra; Leonas, Linas; Lesauskaitė, Vaiva; Liegiūtė, Sigutė; Liukaitis, Valdas; Lukoševičius, Leonardas; Martinkutė, Vestina; Mašanauskienė, Edita; Mickienė, Auksė; Milašius, Arvydas; Miliauskas, Rimvydas; Minkauskienė, Meilė; Mitraitė, Dalia; Monastyreckienė, Eglė; Morkūnienė, Ramunė; Naudžiūnas, Albinas; Obelenis, Vytautas; Palubinskienė, Jolita; Paknys, Gintaras; Pangonytė, Dalia; Paužienė, Neringa; Pavilonis, Alvydas; Pilvinienė, Rugilė; Plančiūnienė, Rita; Poškaitis, Vytautas; Pranys, Darius; Pukenytė, Evelina; Raškevičienė, Rita; Rekienė, Daiva Emilija; Rodovičius, Hiliaras; Sadauskas, Saulius; Starkuvienė, Skirmantė; Stropus, Stasys Rimvydas; Sveikata, Audrius; Šalomskaitė-Davalgienė, Sonata; Šarauskas, Valdas; Šiugžda, Remigijus; Šveikauskas, Vaclovas; Unikauskas, Alvydas; Urbanavičius, Linas; Ustinavičienė, Rūta; Vaičekauskas, Vytautas; Vaičienė, Nerija; Vaitkus, Antanas; Valančiūtė, Angelija; Vasilavičius, Paulius; Vėlyvytė, Daiva; Venskutonis, Donatas; Vieželienė, Dalė; Vitkus, Aleksandras; Zavadskaitė, Jurgita [Zaveckienė, Jurgita]; Zaveckas, Vidmantas [Zaveckas, Vidmantas]. Medicinos probleminis mokymasis: Ikiklinikinės studijos : II dalis : Universiteto vadovėlis / [Sudaryt.: Aušra Burkauskienė, Romualdas Gailys, Laima Ivanovienė, Konstancija Jankauskienė, Egidijus Kėvelaitis, Linas Leonas, Arvydas Milašius, Rimvydas Miliauskas, Albinas Naudžiūnas, Alvydas Pavilonis, Rimvydas Stropus, Donatas Venskutonis, Aleksandras Vitkus] ; [Aut.: Vidmanatas Aželis, Ingrida Balnytė, Rasa Banienė, Algis Bertulis, Tomas Biržietis, Saulius Bradulskis, Vytautas Budnikas, Aleksandr Bulatov, Aušra Burkauskienė, Jūratė Burneckienė, Genuvaitė Civinskienė, Aldona Čerkašina, Arvydas Čižauskas, Anita Dabužinskienė, Virmantas Daubaras, Kazys Daukša, Greta Gailienė, Romualdas Gailys, Vytautas Gedrimas, Valdemaras Giedrimas, Rymantė Gleiznienė, Inga Gudinavičienė, Alfredas Hofmanas ir kt.] ; Kauno medicinos universitetas ; [Recenzentai: Abdonas Tamošiūnas, Audris Visokinskas]. Kaunas : Vitae Litera, p. : lent, pav. ISBN Prieiga per internetą:. 9/1/18 European Union, Page 3 / 6
4 7.Aželis, Vidmantas; Balnytė, Ingrida; Banienė, Rasa; Bertulis-Čerkelis, Algis Povilas; Biržietis, Tomas; Bradulskis, Saulius; Budnikas, Vytautas; Bulatov, Aleksandr; Burkauskienė, Aušra; Burneckienė, Jūratė Marija; Civinskienė, Genuvaitė; Čerkašina, Aldona; Čižauskas, Arvydas; Dabužinskienė, Anita; Daubaras, Virmantas; Daukša, Kazys; Gailienė, Greta; Gailys, Romualdas; Gedrimas, Vytautas Leonas; Giedrimas, Voldemaras; Gleiznienė, Rymantė; Gudinavičienė, Inga; Hofmanas, Alfredas; Ivanovienė, Laima; Jančiauskas, Dainius; Jankauskienė, Konstancija; Jankūnas, Rimas Jonas; Janulaitytė-Gunther, Daiva; Januškevičius, Vidmantas; Juočas, Juozas; Jurkštienė, Vilma; Kalesinskas, Romas Jonas; Kareivienė, Violeta; Kėvelaitis, Egidijus; Kirikova, Liudmila; Kiudelienė, Živilė; Kondrotas, Anatolijus Juozas; Korotkich, Igor; Kutkevičius, Juozas; Lasienė, Kristina; Laukevičienė, Alė; Lažauskas, Robertas; Leišytė, Palmyra; Lekauskaitė, Aušra; Leonas, Linas; Lesauskaitė, Vaiva; Liegiūtė, Sigutė; Liukaitis, Valdas; Lukoševičius, Leonardas; Martinkutė, Vestina; Mašanauskienė, Edita; Mickienė, Auksė; Milašius, Arvydas; Miliauskas, Rimvydas; Minkauskienė, Meilė; Mitraitė, Dalia; Monastyreckienė, Eglė; Morkūnienė, Ramunė; Naudžiūnas, Albinas; Obelenis, Vytautas; Palubinskienė, Jolita; Paknys, Gintaras; Pangonytė, Dalia; Paužienė, Neringa; Pavilonis, Alvydas; Pilvinienė, Rugilė; Plančiūnienė, Rita; Poškaitis, Vytautas; Pranys, Darius; Pukenytė, Evelina; Raškevičienė, Rita; Rekienė, Daiva Emilija; Rodovičius, Hiliaras; Sadauskas, Saulius; Starkuvienė, Skirmantė; Stropus, Stasys Rimvydas; Sveikata, Audrius; Šalomskaitė-Davalgienė, Sonata; Šarauskas, Valdas; Šiugžda, Remigijus; Šveikauskas, Vaclovas; Unikauskas, Alvydas; Urbanavičius, Linas; Ustinavičienė, Rūta; Vaičekauskas, Vytautas; Vaičienė, Nerija; Vaitkus, Antanas; Valančiūtė, Angelija; Vasilavičius, Paulius; Vėlyvytė, Daiva; Venskutonis, Donatas; Vieželienė, Dalė; Vitkus, Aleksandras; Zavadskaitė, Jurgita [Zaveckienė, Jurgita]; Zaveckas, Vidmantas [Zaveckas, Vidmantas]. Medicinos probleminis mokymasis: Ikiklinikinės studijos : I dalis : Universiteto vadovėlis / [Sudaryt.: Aušra Burkauskienė, Romualdas Gailys, Laima Ivanovienė, Konstancija Jankauskienė, Egidijus Kėvelaitis, Linas Leonas, Arvydas Milašius, Rimvydas Miliauskas, Albinas Naudžiūnas, Alvydas Pavilonis, Rimvydas Stropus, Donatas Venskutonis, Aleksandras Vitkus] ; [Aut.: Vidmanatas Aželis, Ingrida Balnytė, Rasa Banienė, Algis Bertulis, Tomas Biržietis, Saulius Bradulskis, Vytautas Budnikas, Aleksandr Bulatov, Aušra Burkauskienė, Jūratė Burneckienė, Genuvaitė Civinskienė, Aldona Čerkašina, Arvydas Čižauskas, Anita Dabužinskienė, Virmantas Daubaras, Kazys Daukša, Greta Gailienė, Romualdas Gailys, Vytautas Gedrimas, Valdemaras Giedrimas, Rymantė Gleiznienė, Inga Gudinavičienė, Alfredas Hofmanas ir kt.] ; Kauno medicinos universitetas ; [Recenzentai: Abdonas Tamošiūnas, Audris Visokinskas]. Kaunas : Vitae Litera, p. : lent, pav. ISBN Prieiga per internetą:. 8.Milvidaitė, Irena; Lukšienė, Dalia; Šlapikienė, Birutė; Babarskienė, Rūta Marija; Liukaitis, Valdas; Mačiulaitis, Romaldas; Kaduševičius, Edmundas; Pilvinienė, Rugilė. Antrinė išeminės širdies ligos profilaktika 9/1/18 European Union, Page 4 / 6
5 persirgus miokardo infarktu (medikamentinio gydymo įvertinimas remiantis anketinės apklausos duomenimis) / Irena Milvidaitė, Dalia Lukšienė, Birutė Šlapikienė, Marija Rūta Babarskienė, Valdas Liukaitis, Romas Mačiulaitis, Edmundas Kaduševičius, Rugilė Pilvinienė // Medicina. (Klinikiniai tyrimai). ISSN X. 2007, t. 43, Nr. 2, p Prieiga per internetą:. 9.Ragaišis, Donatas; Liukaitis, Valdas. Svarbesni nesteroidinių vaistų nuo uždegimo bendrosios ir klinikinės farmakologijos aspektai / Donatas Ragaišis, Valdas Liukaitis // Farmakoterapija. Apžvalgos ir aktualijos. (Skausmą slopinantys vaistai). ISSN , Nr. 1, p Liukaitis, Valdas. Adrenoreceptorių poveikis organizmo funkcijoms / Valdas Liukaitis // Medicina. (Tęstinės medicinos studijos). ISSN X. 2005, t. 41, Nr. 8, p Prieiga per internetą:. 10.Liukaitis, Valdas. Naloksono farmakologinės savybės / V. Liukaitis // Narkotinių ir psichotropinių preparatų sukeltos kritinės būklės : konferencijos medžiaga : 2005 m. gegužės 27 d. / Lietuvos intensyviosios terapijos draugija, Kauno medicinos universiteto Intensyviosios terapijos klinika. Kaunas : [s.n.], p Liukaitis, Valdas; Reingardienė, Dagmara Ona. Pokyčiai elektrokardiogramoje, atsiradę galvos smegenų patologijos metu / V. Liukaitis, D. Reingardienė // Ūminė smegenų patologija intensyviojoje terapijoje : konferencijos medžiaga : 2005 m. vasario 25 d, Kaunas / Lietuvos intensyviosios terapijos draugija, Kauno medicinos universiteto Intensyviosios terapijos klinika; [atsakinga redaktorė Dagmara Reingardienė]. Kaunas : UAB Dalios dizainas, p Liukaitis, Valdas. Prokainamidas / Valdas Liukaitis // Antiaritminiai vaistai intensyviojoje terapijoje : konferencijos medžiaga : Kaunas, 2005 m. spalio 28 d. / Lietuvos intensyviosios terapijos draugija, Kauno medicinos universiteto Intensyviosios terapijos klinika ; [atsakinga redaktorė Dagmara Reingardienė]. Kaunas : Lietuvos intensyviosios terapijos draugija, p Liukaitis, Valdas; Milašius, Arvydas. Adrenoreceptoriai ir jų pasiskirstymas organizme / Valdas Liukaitis, Arvydas Milašius // Vazopresiniai ir inotropiniai vaistai : konferencijos medžiaga : 2004 m. spalio 29, Kaunas / Lietuvos intensyviosios terapijos draugija ; [atsakinga redaktorė D. Reingardienė]. [Kaunas], p Liukaitis, Valdas. Elektrokardiogramos pokyčių, atsiradusių susiformavus įvairios etiologijos ūminėms intrakranijinėms kraujosruvoms, įvertinimas : daktaro disertacija : biomedicinos mokslai, medicina (07B) / Valdas Liukaitis ; Kauno medicinos universitetas. Kaunas, , [2] lap. : lent, diagr.. 15.Liukaitis, Valdas. Elektrokardiogramos pokyčių, atsiradusių susiformavus įvairios etiologijos ūminėms intrakranijinėms kraujosruvoms, įvertinimas : daktaro disertacijos santrauka : biomedicinos mokslai, medicina (07B) / Valdas Liukaitis ; Kauno medicinos universitetas. Kaunas : Technologija, p. : lent, diagr.. 9/1/18 European Union, Page 5 / 6
6 16.Liukaitis, Valdas; Reingardienė, Dagmara-Ona. EKG pokyčiai ligoniams, patyrusiems galvos smegenų traumą / Valdas Liukaitis, Dagmara Reingardienė // Kardiologijos seminarai : Diabeto ir metabolinio sindromo reikšmė kardiologijoje. ISSN , vol. 8, Nr. 2, p Liukaitis, Valdas; Tarasevičius, Rimantas. Acute intracranial eventsand ECG disorders / V. Liukaitis, R. Tarasevičius // 50th Anniversary Congress of Lithuanian Neurosurgery : programme and abstract book, Kaunas, Lithuania, May 24-26, Kaunas. 18.Liukaitis, Valdas. Arterinės hipertenzijos sukeltų intracerebrinių hemoragijų sąlygoti EKG pakitimai = Intracerebral hemorrhages which provoked arterial hypertension and ECG changes / V. Liukaitis // Kardiologijos seminarai : Kardiologija Lietuvoje 2001 metais. ISSN , t.7, Nr.2, p Liukaitis, Valdas. Neurologinių ligonių hipertermija / V. Liukaitis // Karščiavimo problemos intensyviojoje terapijoje : konferencijos medžiaga, 2001 m. kovo 16 d, Kaunas. [Kaunas : LITD], p Liukaitis, Valdas; Reingardienė, Dagmara-Ona. QT intervalo pailgėjimas, jo priežastys ir pasekmės = Prolongation of the QT interval, causes and effects / V. Liukaitis, D. Reingardienė // Medicinos teorija ir praktika = Theory and Practice in medicine. SK-IMPEX Ltd filialas. (Literatūros apžvalga). ISSN , Nr. 4(28), p : lent. 21.Reingardienė, Dagmara-Ona; Liukaitis, Valdas; Tarasevičius, Rimantas; Klementavičienė, Jolita. Intrakranijinės hemoragijos ir EKG pakitimai / Dagmara Reingardienė, Valdas Liukaitis, Rimantas Tarasevičius, Jolita Klementavičienė // Lithuanian journal of cardiology. Kaunas : Institute of Cardiology. 1999, vol. 6, No. 4, p Projects Memberships 1. Lietuvos Intensyviosios terapijos draugija / Lithuanian Intensive Care association 2. Alternative Member of Lithuania in CMD(h) Other Relevant Information 9/1/18 European Union, Page 6 / 6
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