I

Organization Uni ver si ty of S ie na in col labora t i on wi th Scie nces Academy (Maste r Coor di na t i on)

Venue Uni ver si ty of S ie na Me di cal School , S ie na - I ta ly (Hospi ta l a nd L abor ator ie s) GSK Vacci ne s , S ie na - I ta ly (D evel opme nt De par tments , Re sear ch Ce nter a nd L abora tor i es) GSK Vacci ne s Inst i tute for G loba l Hea l th S .r . l . , S i ena - I ta l y Publ i c Heal th ( I mmuniza t ion Ce nters) , S ie na - I ta l y

Duration June 2015 – De ce mber 2 016

Sponsors Uni ver si tà deg l i S tudi di S ie na GSK Vacci ne s Bi l l & Mel inda Ga te s Founda ti on Sa nof i Pa ste ur Ta ke da Vacci ne s ADI TEC , EU

Letter from the director

P rof . Sue Ann Costa Cleme ns Hea d Scie nce s Aca demy Prof . Ped ia tr i cs I nfect ious Di sea se s

To thi s da te much of the de vel opi ng wor l d pose s many chal le nges to e njoy ing l i fe f ree of va cci ne pre ve nta ble di sea se s; de sp i te most gover nme nt ’s good -w i l l and the de si re to e ase the bur de n of these di sea ses . To a ch ie ve thi s goal , de vel opi ng countr i es nee d to ha ve nat i ve , wel l - r oun de d pr ofessi onals i n the f ie l ds of i mmuniza t ion , publ i c he al th a nd i nfe ct i ous di sea ses . Pr ofessi onals who ca n a ppre cia te the i mpa ct of va cci ne preventable diseases fr om di ffer ent angle s : va l ue of va cc ines , va cci ne re sea r ch a nd de vel opment , va cci ne sa fe ty , va cci ne procurement a nd va cci ne de l i ver y. L i ke wise , he al th ca re pr ofessi onal s f r om de vel ope d countr i es woul d be ne f i t for themsel ve s a nd woul d contr i bute to gl obal heal th by more i n -depth under standi ng of the contr ibut i on of immuni za t i on a nd va cci ne s to gl o bal devel opme nt.

The Ma ster Pr ogram i n Vacci nol ogy and Phar ma ceuti ca l De vel opme nt pr ov ide s hi gh qual i ty educa ti on i nvo lv i ng wor l d -wi de key op in ion lea de rs. Thi s pr ogra m whi ch s tar te d i n 2008 , ha s gra dua te d more tha n 30 stude nts f r om the de vel opi ng wor ld wh o are now making a di f fere nce in the i r countr ie s. Th is ye ar , 15 new Vacci nol ogy pr ofessi onal s f r om Afr i ca , Asia and La t i n Ame r i ca wi l l go back to the i r countr ie s to s tar t new caree rs. I am conf i de nt tha t very soon we wi l l se e the impact tha t the y wi l l ha v e thr ough the i r contr i but ions .

This pr ogr am de ma nds e xcel le nce in e ver y a spe ct , f r om the wor l dwi de expert i se of the tea chi ng staf f to the s tude nt ’ s le ve l of commi tme nt a nd de di ca t i on. I am pa rt icul ar l y i mpresse d wi th the i r tr ue de si re to le ar n, impr ove a nd ma ke a di f fere nce i n the i r countr ie s.

The succe ss of thi s pr ogr am i s a col la bora t i ve e f for t a nd a uni que par tner shi p be twee n industry and academia to he l p de vel opi ng countr ie s to ove rcome some of the gaps i n va cci nol ogy, v ia a ver y so l i d tool - Educa ti on . Th is pr ogram hel ps the countr ie s to bui l d the i r own resources , to di sse mi na te knowle dge , to de vel op ne w pr ofe ssi onals and spe cia l ly he l ps the de vel opi ng countr ies to be i ndepende nt on key aspe cts a s phar ma covi gi lance , re gula tor y a nd e pi demiol ogy.

S i ncere l y ,

Prof . Dr . Sue Ann Costa Cleme ns

Master Technical Scientific Committee

Prof. Emanuele Montomol i Di r ect or TSC Pr of es s o r of P ub l ic H ea l t h , D ep t . of M ol ecu lar an d D ev e l o pme nt a l M ed ice – U n iv ers i ty of S i e na , I ta ly

Prof. Dr. Sue Ann Costa Clemens H ead Sc ie nces A ca de my Pr of . P ed iat r ics I nfec t i ous D is e as es

Prof. Ranuccio Nuti De pa rtm en t of I nt er na l Me dic i n e , U niv e rs i ty of S ie na

Dr. Stefania Rossi R es ear ch er of P u bl ic H ea l t h De pt . of Mo lec ula r a nd Dev e lo pm e nta l Me dic in e A rea of P u bl ic H e a l t h , U niv e rs i ty of S ie na

Prof. Franco Laghi Pasini H ead De pa rtm en t of C l in ica l Me dic i ne a n d Immu n ol o gy , U niv e rs i ty of S ie na

Dr. Audino Podda H ead, C l in ica l D ev e lo pm en t & R e g ula to ry A f fa i rs , GS K Vacc i ne I ns t i tu te f or G lo ba l H ea l th , S i en a , I ta ly

Dr. Giovanni Del la C ioppa H ead R & D C e nt re I ta ly , , GSK

Dr. Emanuela Pal la H ead I ta ly R S O, GSK

Organized by Universiy of Siena

The Master Program - Our Vision

Peopl e i n de vel opi ng countr ie s nee d l i fe -sa vi ng vacci ne s – a nd the y nee d them now. But ma ki ng this ha ppen i s not s imple . I t re qui re s tra i ne d profe ss iona ls to rol l out e f fe ct ive na t i onal

immuniza t i on p la ns , to genera te l ocal c l i n ica l da ta on vacci ne safety a nd ef f ica cy , a nd to shar e the i r publ i c heal th e xper t ise wi th other s.

This me ans eq ui ppi ng l ocal e xper ts wi th i nter na ti onal l y r ecogni ze d ski l l s . Thr ough our Master Pr ogram i n Vacci nol ogy a nd Phar ma ce ut ica l C l i n i ca l D evel opme nt , young

doctor s de vel op the va l uable sci ent i f i c a nd pra ct i ca l knowhow the y ne ed to jo in the ne w ge ner at ion of publ i c heal th lea der s i n de vel opi ng countr ies .

Every two ye ars , we se l e ct a nd tr a i n the best me dical gra dua tes from de ve lopi ng countr i es a cr oss the gl obe – countr ie s tha t are most in nee d of ha v ing a cce ss to va ccines a t low costs .

Gradua te s of our pr ogra m re tur n home wi th a bet ter under sta ndi ng of the i r countr ie s ’ e pi de mi ol ogy and publ i c he al th nee ds . And wi th the i r top -cl ass knowle dge a nd sk i l ls , the y br i ng hope where i t i s

nee de d most . The Ma ster Pr ogram of the Scie nce s Aca demy a nd Univers i ty of S ie na of f ers a hope for

de vel opment .

In Collaboration with Sciences Academy

Master Coordination

Prof. Dr. Sue Ann Costa Clemens H ead Sc ie nces A ca de my Pr of . P ed iat r ics Infe ct i o us D is e as es

Dr. Bernadette Hendrickx Sen io r M ed ica l A dv is or

Dr. T iziana Musso Mas t er Pr o gra m C o or d i na to r

Mr. Danie le Sereni Ma na ge r C om mu nic at i o n Des i g n an d I nf orm at ics , Sc ie nces A ca demy

Mrs. Michela Gal lo Mas t er Pr o gra m A s s is ta nt

Dr. Audino Podda H ead, C l in ica l Dev e lo pm e nt & R eg ula to ry A f fa i rs , GS K Vacc i ne I ns t i tu te f or G lo ba l H ea l th , S i en a , I ta ly

Index Th e Mas te r Co u rse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

M od u le I : Pu bl i c hea lth , im mu n izat i on an d va c ci ne dev el op me nt p ro c ess . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

M od u le II : V a cc i ne imm un o l og y an d p re c li n ic al re sea r ch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

M od u le II I : Va c c ine ma nuf ac tu r in g a nd qu al it y c on t ro l p r oc esse s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

M od u le IV: I nf ec t io us d ise ase s an d va c c ine p r even ti o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

M od u le V : C l in i ca l D eve lop men t Me tho d ol o gy , B io sta ti st i cs a nd C l in i ca l Da ta M an ag eme nt . . . . . . . . . . . . 8

M od u le V I : Pha r ma cov i gi la n ce . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1

M od u le V I I : Ep i dem i o lo gy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2

M od u le V I II : GCP, C l in i cal Qua l ity A ssu r an ce a nd Cl i n ic al Tr ia l Op er at i o ns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 3

M od u le IX : Re gu l at or y Affa i rs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 4

M od u le X : Po l ic i es a nd re co m men da t io ns f o r va c cin es in the w o r ld . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 5

Se mi na rs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 7

H o w t o p r oc ee d . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 8

Pa r ts o f th is br oc h ur e ca n be up da te d at a ny t im e wi t h ou t a pr ev i ous n ot ic e Pa ge 1 of 1 9

The Master Course Goals Capaci ty bui ldi ng i n va cc inol ogy a nd va cc ine de ve lopme nt ;

To pre pare stude nts for a ca reer in a ca de mia , publ ic he al th a nd r ese arch a nd de vel opme nt i n publ i c a nd pr i va te vacci ne i nst i tute s.

Concept To pr ov ide gra dua te s i n m edici ne wi th tra i ni ng i n ep idemi ol ogy a nd di sea s e bur de n of vacci ne

pre ve nta ble in fe ct i ous di sea ses , va cci ne de vel opment f rom r esea rch to l i censure a nd va cci ne pol i cy a nd fundi ng ;

Is a col la bora t i ve e f for t be twee n a ca de mia a nd vacci ne industry ; Combines the ore t i ca l and pra ct i ca l t ra i ni ng i n immunol ogy , i nfect i ous d isease s a nd va cci nol ogy ,

f r om resear ch to l i ce nsur e. The tr a i ni ng i s g i ve n by wor l dwi de e xper ts f r om aca demia , wel l known inter nat iona l univers i t ie s , supra na ti onal or ga niza t i ons (e .g. EMA, Sabi n Inst i tute , Bi l l & Mel i nda Ga tes Founda ti on) a nd i ndustry .

Program overview

Program agenda (One year) Module I : Publ ic Hea l th a nd Va cci ne De vel opme nt Proce ss ;

Module I I : Vacci ne Immunol ogy a nd Pr ecl in ica l Resear ch ;

Module I I I : Va cc ine Ma nufa ctur ing a nd Qual i ty Contr ol Pr ocesse s ;

Module I V : I n fe ct i ous Di sease s a nd Vacci ne Pr eve nti on ;

Module V : C l i n ica l Devel opme nt Me thodol ogy, Bi osta t i s t i cs a nd C l in ica l Da ta ma na ge me nt;

Module VI : Pharma covi gi lance ;

Module VI I : Epi de mio logy ;

Module VI I I : C l i n i ca l Qual i ty Assura nce and Cl i ni ca l Tr ia l Opera t i on s;

Module I X: Re gul a tor y Af fa i r s ;

Module X: Pol i c ie s and Recomme nda tions for Vacci ne s i n the Wor l d ;

Extr a Cur r icul um Modul e s: semi nar s .

Internship (Six months) six -months i nter nshi p :

o wi th in di f fer ent de par tments of the G SK Va ccines a nd Sanof i -Pa ste ur ; o at the Uni ver s i ty Hospi ta l o f S ie na;

cl i ni ca l s i te v is i ts : o invest i ga tor s mee ti ng / s i te feasi bi l i ty o study s tar t/cl osure

Pa r ts o f th is br oc h ur e ca n be up da te d at a ny t im e wi t h ou t a pr ev i ous n ot ic e Pa ge 2 of 1 9

o moni tor i ng

Students Evaluation Wri tten e xams af ter ea ch modul e a nd a cumula t i ve one a t the e nd of the f i rs t year ;

In ter nsh ip : stude nts ’ per forma nce is asse ssed by supe rvi sors a nd maste r coor di na t i on based on act i v i t ie s a nd overa l l t ra i ni ng a nd de l ive ra bles dur ing th e 6 month i nter nshi p per iod .

Thesis Ea ch s tude nt wi l l se le ct a subje ct for a wr i t te n thesis ;

The the sis w i l l be submi t te d to Uni ver s i ty of S i ena a nd di scussed a t the e nd of the Pr ogram.

Pa r ts o f th is br oc h ur e ca n be up da te d at a ny t im e wi t h ou t a pr ev i ous n ot ic e Pa ge 3 of 1 9

Pa r ts o f th is br oc h ur e ca n be up da te d at a ny t im e wi t h ou t a pr ev i ous n ot ic e Pa ge 4 of 1 9

Module I: Public health, immunization and vaccine development process

Directors

Prof . Dr . Ema nuel e Montomol i Pr of es s o r of P ub l ic H ea l t h , D ep t . of M ol ecu la r an d Dev e lo pm e nta l Me dic e – U n iv e rs i ty of S i en a , I ta ly

Prof . Dr . Sue Ann Costa C lemens Pr of . P ed iat r ics I nfec t i ous D is e as es , R io de J an e i ro ,

Braz i l H ead Sc ie nces A ca de my , S i ena , I t a ly

Aim

To ge t a ge nera l overvi e w on i mmunizat ion a nd publ i c hea l th i n the wor l d and to under sta nd the overa l l p r i nci pl es of phar maceuti ca l de vel opme nt pr ocess fr om re sear ch to the ma rket .

Contents Publ i c Heal th ba si c concepts ;

The r ole of va cc ine s i n publ i c hea l th ;

Role of s ta ke hol ders ;

Gover nme nts , NGO’ s , Suprana ti onal Or ga ni za t i ons ;

Academia ;

Va cci ne i ndustr y ;

Va cci ne de vel opme nt proce ss ;

Fr om resear ch to l icensure a nd re comme nda ti ons ;

How va cci ne compa nie s functi on ;

How to ma nage pr oje cts i n va cci ne compa ni es ;

Pa r ts o f th is br oc h ur e ca n be up da te d at a ny t im e wi t h ou t a pr ev i ous n ot ic e Pa ge 5 of 1 9

Module II: Vaccine immunology and preclinical research

Directors

Prof . Dr . Ema nuel e Montomol i Pr of es s o r of P ub l ic H ea l t h , D ep t . of M ol ec ula r an d D ev e l o pm en ta l

Me dic e – U n iv ers i ty o f S ie n a , I t a ly

Dr . Ema nuela Pal la H ead I ta ly R S O, G SK, S i en a ,

I ta ly

Dr . John Te l for d H ead of M ic r o bia l M olec ul a r

B io lo gy , GS K, S ie na , I t a ly

Aim

To understa nd the ba si c conce pts of i mmunol ogy, immune re sponse to va cci ne s a nd how to tra nsla te thi s in to va cci ne deve lopme nt a nd l icens ing.

Contents Hi stor i ca l ba ckgr ound to va cc inat ion :

o Huma n Immune re sponse :

Inna te immuni ty ;

B-cel l and T -ce l l re sponses;

How to measur e B a nd T ce l l functi on.

Ide nti f i ca t i on of va cc ine tar ge ts:

o Anti ge n s tr ucture s a s pote ntia l vacci ne ca ndida te s;

o Conve nti onal a nd no vel a ppr oa ches to vacci ne de velopment .

Type of va cci ne s ;

The r ole of a djuva nts ;

Pre-cl i n i ca l e va l ua t i on of va cci ne immunol ogy a nd sa fe ty;

Analysi s of i mmune response to va cci nes i n huma ns :

o Anti body re sponse ;

o Functi onal a ssa ys ver sus qua nti ta t i ve assa ys .

Pa r ts o f th is br oc h ur e ca n be up da te d at a ny t im e wi t h ou t a pr ev i ous n ot ic e Pa ge 6 of 1 9

Module III: Vaccine manufacturing and quality control processes

Directors

Prof . Dr . Ema nuel e Montomol i Pr of es s o r of P ub l ic H ea l t h , D ep t . of M ol ec ula r an d D ev e l o pm en ta l

Me dic e – U n iv ers i ty o f S ie n a , I ta ly

Dr . Massimo Bugnol i O pe rat i o na l Ma na ge r , Bac te r ia l

s egm en t , GSK, S i e na , I ta ly

Dr . Ra hul Si nghvi H ead Ma n ufact u r i n gt , Tak e da

Vacc i nes , USA

Aim

To ge t an understa ndi ng of conce pts , me thods a nd chal l enge s of techni ca l oper at ions and qual i ty of va cc ine manufa ctur i ng.

Contents Shor t his tor y of Va cci ne s Ma nu fa ctur ing

Dif fere nce s be twee n Pha rma a nd Vacci ne s

Obje ct ives of producti on

Cl i nica l l o ts o Mar ke t supply o Re gula tory Compl i ance

Fundame ntal P i l l ars of Manufa ctur i ng

Conce pts i n va cci nes ma nufactur i ng pre se nt and future

Proce ss De vel opment

Te chnica l t ra nsfer , s ca l e up , cost of goods , suppl y chai n , e nge neer i ng

Qual i ty Contr ol

Analyt i ca l Chara cter iza t i on a nd lot potency

Vira l pr oducti on

Qual i ty Assura nce / i nspecti ons

Pa r ts o f th is br oc h ur e ca n be up da te d at a ny t im e wi t h ou t a pr ev i ous n ot ic e Pa ge 7 of 1 9

Module IV: Infectious diseases and vaccine prevention

Directors

Prof . Rober to G aspa r i ni Pr inc ip a l o f th e H y gi e ne a n d P rev en t iv e Me dic i n e

Me dica l Sch o ol , Un iv ers i ty of Ge n oa , I ta ly

Dr . Audi no Podda H ead C l in ica l Dev e lo pm e nt & R e g ula to ry A f fa i rs , GS K Vacc in e Ins t i t ut e f o r G l ob a l

H ea l t h , S ie na , I t a ly

Aim

To ge t fa mi l iar w i th the most i mpor tant vacci ne pre ve nta ble in fe ct i ous di sea ses f rom a cl i n i ca l a nd fr om a gl obal e pidemi ol ogi ca l perspe cti ve . To le arn whi ch va cci ne s are a l r ea dy a vai la ble a ga inst these i n fe ct i ous di sease s a nd whi ch ne w va cc ines are be i ng devel ope d.

Contents

Ba cter ia l d i sea ses : c l in ica l pr of i le , e pi demi ol ogy, and va cci ne s:

o Diphther ia , Te ta nus, Per tussi s , Hae mophi l us i n f l uenza type b di sea se , Me ningococcal di sea se , Pne umococcal d isea se , L yme d isea se Bor re l iosi s , Gr oup A Str eptococca l di sea ses , Group B Stre ptococcal di sea se , S ta phyl ococcal d i sea se , Tuber cul osis , He l i cobacter pyl or i in fe ct ion , Cholera , Enter otoxi ge ni c Escher i chia col i , Sa lmonel l osi s , Shi ge l losis , O thers

Vira l d iseases : c l i n i ca l prof i le , e pi de mi ology, a nd va cc ines :

o He pa ti t i s A , B , C a nd E , Mea sle s , Mumps, Rubel la , Var i ce l la & Zoster , I nf luenza & Pa nde mic Inf l ue nza , Re spi ra tory syncytia l v i r us , Cytomegal ovi r us , HI V/AID S, Ti ck Bor ne ence phal i t is , Ja pa nese e nce phal i t i s , Y e l low Fe ver , De ngue Feve r , Ra bie s , Huma n pa pi l lomavir us , Her pe s Simple x v i r us , Rota vi r us , Ebola , Malar ia , N or ovi r uses

Pa r ts o f th is br oc h ur e ca n be up da te d at a ny t im e wi t h ou t a pr ev i ous n ot ic e Pa ge 8 of 1 9

Module V: Clinical Development Methodology, Biostatistics and Clinical Data Management

Directors

Prof . S te fa nia Rossi R es ear ch er - Sta t is t ic ia n ,

De pa rtm en t of Mo lec ula r a n d Dev e lo pm e nta l Me dic in e , U niv e rs i ty of S ie na , I t a ly

Dr . G i ova nni D el la C i oppa H ead R & D C e nt re I ta ly , G SK ,

S ie na , I ta ly

Dr . Uwe Ni cola y H ead B i os ta t is t ics & Stat is t ica l R ep o rt i n g

Si te H ea d Dev e lo pm en t Mar b u rg

GSK, M ar b ur g , Ge rma ny

Aim

To understand the ba si c pr i nci ple s of c l i n i ca l t r ia l me thodology, e spec ia l l y i n vacci ne de vel opme nt . To understa nd basi c conce pts of s ta t i s t i cs a nd data ma na ge me nt for c l i n i ca l t r ia l s .

Contents Over vie w of the cl i n i ca l devel opme nt :

o Cl i nica l de vel opme nt p la ns ; o Pha se s of the c l i n ica l de vel opme nt pr oce ss : Phase I - I I - I I I - I V tr ia ls ; o Exper ime nta l s tudie s (c l i n i ca l t r ia l s) vs . ep idemi o logi ca l (observa t i onal ) s tudie s ; o Li fe -cycle of a pr oduct ; o Geogra phi ca l , l ogi st ica l & e conomi c consi dera t i ons . o Cl i nica l t r i a l me thodol ogy a nd pr otocol de vel opment : o Why cl i n i ca l t r ia ls? Var ia bi l i ty of bi ol ogi ca l phe nomena a nd mea sureme nt e r ror s ; o Defi ni ng the trea tment e f fe ct : f rom mea sureme nts to e nd -poi nts ; o The choi ce of the sa mple : whi ch subjects , how ma ny subje cts ; o The choi ce of tre a tme nts : s tudy tr ea tme nts , concomi ta nt trea tme nts ; o Exper ime nta l desi gns ; o The pr otocol a ppr oval pr ocesse s: i n ter nal , e x ter nal , a me ndme nts .

Va cci ne tr i a l me thodol ogy :

o Safe ty , i mmunoge ni ci ty , e f f ica cy a nd e ffect ive ne ss ; o Sur roga te end -poi nts , corre la tes of pr otect i on a nd constr a ins of ser ol ogi ca l e nd -poi nts ; o Eth ica l consi de ra t i ons in c l in ica l de vel opme nt .

Sta tis t i ca l me thodol ogy for c l i n i ca l t r ia ls :

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o Ba si cs , In ter nat iona l Confere nce on Harmoni za t i on ( I CH) gui de l i ne s (E8 , E9 , E10) , EMEA/FD A gui del ines ;

o Descr i pt i ve vs . i n fer enti a l s ta t i s t i cs ; o Impor ta nce of ra ndom i za ti on to avoi d bi as ; o Power & sample s ize ca l cula t i ons for hypothe sis test i ng ; o Super ior i ty , e qui va le nce , non - i nfe r ior i ty ; o Desi gns & analy t i ca l a pproa che s; o Endpoi nts (me asure s and var ia bles) , surr oga te , marker s; o P-val ue s: s ta t is t i ca l a nd cl i n i ca l s i gni f i ca nce; o Sta tis t i ca l a nal ys is pla n; o In ter i m a na lyse s, me ta a nal yses ; o Al i gnme nt of pr otocol , data co l le ct i on a nd re por ts.

Cl i nica l Da ta Ma na ge me nt :

o Case Re por t Form (CRF) de si gn ; o Ele ctr onic Da ta Capture and pa per CRF pr oce sse s a nd systems; o Database des ign a nd s e tup wi th e di t che cks, ru le s a nd der iva t i ons; o Val i da t i on of computer i zed syste ms for da ta ma nage me nt ; o Data col le ct i on a nd da ta clea ni ng; o Data i nte gra t i on (e .g. la b data tra nsfers) ; o Data qual i ty , da ta base l ock, post da ta ba se l ock cha nges ; o Adver se Eve nt r epor t i ng; o Codi ng di ct i onar ie s ( Me dical D i ct i onar y for Re gul ator y Act iv i t i es [ Me dD RA ] , WHO-dr ug) .

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Module VI: Pharmacovigilance

Directors

Prof . Ema nuele Montomol i Pr of es s o r of P ub l ic H ea l t h , D ep t . of M ol ec ula r an d D ev e l o pm en ta l

Me dic e – U n iv ers i ty o f S ie n a , I ta ly

Dr . Ber na de tte He ndr i ckx C EO a n d F o u nd er of SA H B

C o ns u l t i n g , W av r e , Be l g i um ; Sc ie nces A ca demy S en io r

Me dica l A dv is o r

Dr . Cor i nne Jouquele t -Roye r

VP, H ea d G l o ba l P har mac ov i g i l anc e - S a no f i

Pas t e ur , Ly on , Fra nc e

Aim

To understa nd mai n ra t i onal , be st pra ct i ce a nd pr ese nt over view on Pha rmacov i g i la nce systems in the wor l d. The le ar ning i s focuse d on : how to wr i te a n i ndi v i dual ca se narr at i ve , how to a sse ss ca usal i ty a nd e xpe cte dne ss of case s , how to de ter mine cer ta i nty of dia gnos is a ccordi ng to Br i ghton co l la bora t i on gui de l i ne s.

Contents

In tr oducti on to c l i n i ca l safe ty , Pharmacovi gi la nce a nd be ne f i t - r i sk ma na ge ment ;

Cl i nica l sa fe ty i n the De velopi ng Wor l d;

Sta tutor y ba si s for sa fe ty i n huma ns :

o Hi stor i ca l ba si s ; o Gover ni ng bodi es a nd He al th Author i t ie s: ICH, Counci l for In ter nat iona l Or ga niza t i ons of

Me di cal Scie nce s ( C IOMS ) , WHO; o Safe ty da ta col le ct i on i n c l i n i ca l t r ia l s ; o Sponta ne ous a dverse e ve nts ;

Adver se Eve nts :

o Defi ni t i ons a nd cla ssi f icat i on; o Proce ss ing , ar chi v i ng a nd r et r ie va l ; o Asse ssme nt : expe cte dne ss , l i s te dne ss , ca usal i ty and r efe re nce docume nts o Analysi s a nd deci s i on -maki ng; o Re gula tory Re por t i ng;

Li fe -Cycle C l i n i ca l Pr oduct Sa fe ty :

o Discove ry a nd pre -cl i n i ca l scie nce ; o Pre a nd post a uthor izat i on cl i n i ca l safe ty; o Structure d be ne f i t - r i sk a sse ssme nt and ma na ge ment o Safe ty s tra te gy, i ssue mana ge me nt a nd cr i s i s pre ve ntion o Communi ca t i on i n Pharmacov ig i la nce

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Module VII: Epidemiology

Directors

Prof . Fe l i ce Pe tra gl i a Pr of es s o r of Gy ne co lo gy - U niv e rs i ty of S ie na , I t a ly

Dr . Mar ia nne Cunni ngton H ead E pi demi ol o gy GS K, A ms ter da m, N et he r la n ds

Dr . John Wei l H ead of E p i d emi ol o gy , Take da Vacc i nes , Z ur ich , Sw i tz e r la n d

Aim

To understa nd basi c pr i nci ple s of Epi demi ol ogy a nd He al th Economi cs and the re le va nce for va cc ine de vel opme nt .

Contents Epi demi ol ogy :

o Pr inci pl es of i nfe ct i ous d isea ses e pi demio logy ; o Mea sures of disease occurre nce ; o Mea sures of impa ct ; o Se nsi t i v i ty – spe ci f ic i ty ; o Obser va t i onal s tudie s: cohor t a nd ca se -contr ol , a l ter na t i ve desi gns , how to wr i te a s tudy

pr otocol , choi ce of a re fe rence gr oup, synthes is causal in fer ence , sampl ing ; o Me thodol ogy : ma tchi ng , b ia s , confoundi ng, thi r d factor , d isenta ngl i ng ; o Cal cu la t i on s - a nal ysi s : sample s ize ca l cula t i on, s igni f i ca nce , logi s t i c r egr essi on ; o Sur vei l la nce: pr i nci ples of surve i l la nce , e ve nt ba se d surve i l la nce , a nal y t i ca l tool s in

surve i l la nce , la b -base d sur ve i l la nce , e va l ua t i on of sur ve i l la nce .

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Module VIII: Clinical Quality Assurance and Clinical Trial Operations

Directors

Prof . S te fa no G onnel l i De pa rte me nt o f I n ter na l Me dic i n e , U niv e rs i ty of

S ie na , S ie na I t a ly

Dr . E l isa Mar che tt i H ead C l in ica l O per at i o ns - GSK Vac c i ne i ns t i tu te

for G lo ba l H ea l th , S i e na , I t a ly

Aim

To understa nd the re qui r eme nts a nd to e nsures qual i ty i n c l i n i ca l t r ia ls e xecuti on a nd the opera t i onal re qui reme nts for p la nning a nd e xe cut i ng va cci nes cl i n i ca l t r ia l s .

Contents Elements of the Cl ini ca l Qual i ty System :

o Qual i ty Pol i c i es a nd Qual i ty Ma nual , standa rd Ope rat i ng Pr oce dur es (SOPs) ; o Qual i f i ca t i on a nd tra in ing of s ta ff ; o Qual i f i ca t i on of thi r d par t ie s (Contra ct Re sear ch Organiza t i ons CROs) ; o Tr ia l Master Fi le ; o Audi t i ng : i n ter nal a nd e xter nal a udi t i ng , syste m a udi ts .

Re gula tory i nspe cti ons : o Prepara t i on of a n i nspe cti on (sponsor a nd s i te) ; o Type s, pr oce dur e , re ports , Fr e quent f indi ngs .

In tr oducti on to C l i n i ca l T r ia l Opera t i ons (CTO) : o Fr om protocol to c l in ica l s tudy re por t ; o Cl i nica l pr oject ma na ge ment & pla nni ng .

Cl i nica l t r i a ls pre para t i on : o Protocol , I nfor me d Conse nt Form a nd re la te d documents ; o Label ing & pa cka gi ng of va cc ines ; o Si te qual i f i ca t i on ; o Cl i nica l r ese arch organizat i ons (CRO) ; o Docume nta t i on .

Cl i nica l t r i a l e xe cuti on : o In i t ia t i on v i s i t , m oni tor i ng , s afe ty , s tudy cl osur e .

Database l ock a nd cl ose -out da ta ma na ge me nt a ct iv i t ie s ; Opera t i onal syste ms a nd pr ocesse s :

o Tr ia l ma na ge me nt syste ms ; o Eff i c ie ncie s and qual i ty contr ol i n pr oce ss ; o Cl i nica l S tudy Re por t .

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Module IX: Regulatory Affairs

Directors

Prof . Fr anco La ghi Pa si ni Pr of es s o r of I nt er na l m e dic ine –

U n iv e rs i ty of S ie na , I t a ly

Dr Joche n Auer ba ch H ead R e g ula t ory A f fa i rs –

N VGH -N IBR , S i en a , I ta ly

Dr . Anne -Mar ie Ge or ge s In d i pe n da nt C ons ul ta nt ,

R eg ula to ry A f fa i rs - C ah o r s , Fr anc e

Aim

To understa nd i nter na ti onal re gula tory e nv i ronme nt a nd re qui reme nts re la te d to obta i n a ppr oval for va ccines a nd the mai nte na nce of the se l icenses.

Contents In tr oducti on :

o Gener a l over view of ma in c ompetent a uthor i t ies (FD A, EMA, MHL W); o In ter na ti onal Confere nce on Harmoni za t i on ( ICH) .

Drug de vel opment a nd l i fe cycle f r om a re gula tor y pe rspe cti ve :

o Prec l i ni ca l ; o Pha se I – i n i t ia l sa fe ty o Pha se I I – proof of conce pt , dose ra ng ing ; o Pha se I I I – e f f icacy , lar ge scal e sa fe ty ; o Re gula tory constra i nts of ser ol ogi ca l endpoi nts ; o Post Approval Commi tme nts – studie s to de te ct r are va cc ine a dver se e ve nts , impa ct

studie s; e pi de mio logy; o Hea lth Author i ty re vie w a nd a ppr oval pr oce dure s.

Re gula tory systems:

o US re gula tory system; o EU re gula tory system; o WHO pr equa l i f icat ion proce ss ; o Othe r se le cte d r egula tor y systems.

Product la be l i ng :

o US Pa cka ge I nser t ; o EU Summar y of Pr oduct Cha ra cter is t i cs; o Packa ge i nser ts a nd la be ls , wha t nee ds to be incl ude d? o Re gula tory d i f fere nce s betwee n dr ugs a nd bi ol ogi cs ; o Promot iona l compl ia nce ; o Re gula tory I nspe cti ons

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Module X: Policies and recommendations for vaccines in the world

Directors

Prof . Pa ol o Bona nni De pt . P u bl ic H e a l t h , U niv er s i ty of F l ore nc e , I ta ly

Dr . Audi no Podda H ead, C l in ica l D ev e lo pm en t & R e gu lat o ry A f fa i rs ,

Sc lav o-B eh r i n g Vacc i n e I ns t i t ute f o r G lo b a l H ea l t h , S ie na , I t a ly

Aim

To understa nd that the i ntr oducti on of ne w va cci nes i nto the immuni za t i on ca le ndars of di f fer ent countr i es is de pe nde nt on a number of l ocal a nd i nter na ti onal fa ctor s.

Contents

The r ole of Publ i c Heal th

The r ole of the Eur opea n Communi ty to pr omote vacci na t i on pol i c ie s

Va cci na t i on systems and pol i c i es i n de vel opi ng Countr ies

Hea lth Technol ogy Assessme nt as a tool for pr ior i t i za t i on

Economic a nal ys is a pp l ie d to va cci na t i on pr ograms

Va cci na t i on i n the De vel opi ng Wor l d : the r ole of the GAVI Al l ia nce

Investme nt ca se for va cc ine preventa bl e di sea ses

Va cci na t i on syste ms a nd pol i c ie s in the USA

Publ i c a cceptance of ne w va cc ines

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Master training Room

Siena downtown

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Seminars Aim

To pr ov ide tools for the s tude nts personal a nd pr ofessi onal g rowth.

First and second semester How to re ad a nd i nter pre t scie nt i f i c pa per s ;

How to wr i te a c l i n i ca l t r ia l pr ot ocol a nd a protocol synopsis ;

Hea lth Systems a nd Economi cs ;

How to wr i te an e pi demio logy pr otocol ;

Good C l i ni ca l Pra ct i ces

How to wr i te gr ant a ppl i cat i ons a nd where to a ppl y ;

How to wr i te a the sis ;

How to wr i te a pa per to be publ i she d ;

Prese nta t i on ski l l s ;

Communi ca t i on a nd cr i s i s manageme nt in re la t i on to c l i n i ca l t r i a ls .

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How to proceed Entry Requirements Uni ver si ty de gree i n Human Me di ci ne ;

Exce l le nt command of Engl i sh , wr i t te n a nd spoke n . The ful l Ma ster Pr ogra m i s conducte d in Eng l ish .

* Onl y ADI TEC sp onsor ed ca ndi da te s must be : Curr entl y wor ki ng i n a Europea n Uni on or Associa ted Me mber s ta te or

Curr entl y wor ki ng i n a va cci ne de vel opme nt pro je ct funded by the Eur opea n Commi ssi on or EDCTP.

Funding A 18 -month gra nt wi l l be pr ov ided to stude nts who are acce pte d .

Application & Information

Application to the University of Siena

The I V Ed i t ion of the Ma ster Pr ogram i n Va cci nol ogy w i l l s tar t on June 201 5. The Appl i ca t i on pr ocess i s e xpla i ne d in the Univer s i ty of S i ena a nnounce ment (ba ndo) tha t is avai la bl e a t ht tp :/ /www.unis i . i t /d idat t ica/cors i -post - la ure a/master -uni ver s i tar i (under the hea di ng “Ma ster Exe cut ive ” , cou r ses are or dere d by da te) . Ca ndi da te s must se nd the of f i c ia l a ppl i ca t i on form to the Univer s i ty of S ie na by Fe bruary 05 , 201 5 . Assi stance or fur ther i n format ion to the ca ndi da tes wi l l be pr ovi de d by Sc ience s Aca demy - Ma ster Progra m Coor di na t i on . P l ease se nd a n e -ma i l to master .va cci ne s@uni si . i t b y N ove mber 2 0 , 2014

Contact information Ma ster Coor di na t i on: Mrs. T iz ia na Musso, +39 057 7 24 5253

We b: http://www.unisi.it/didattica/post-laurea/masters/vaccinologia-e-sviluppo-clinico-farmaceutico E -mai l : master .vacci ne s@unisi . i t

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