BioPharm International - October 2021

BioPharm-October 2021-Regulatory-Sourcebook

Issue link: https://www.e-digitaleditions.com/i/1420307

Contents of this Issue

Navigation

Page 30 of 33

www.biopharminternational.com October 2021 eBook BioPharm International 31 and in person. A APS also continued to build its elearning program with w e e k l y w e bi n a r s , e C h a l k Ta l k s , and virtual workshops, all of which a d d e d t o a g r o w i n g o n- d e m a n d library of programs for members. BioPharm: How has COV ID-19 impacted A A PS events? How has the organization worked to resolve the impact? Morris (A APS): A A PS' role in the pandemic has been to bring sci- ent ist s tog et her ov er me a n i n g f u l content so they can continue to both develop responses to the pandemic a nd add ress t he needs of pat ients s u f fe r i n g f rom t he d i s e a s e s t h at are not grabbing current headlines. D u r i n g t he p a s t 18 mont h s , t he association invested in its burgeon- i n g on l i ne A A P S C om mu n it ie s; adde d a fou r-work shop s er ie s on COV ID-19 to its suddenly all-vir- t ua l events l ineup; a nd cont inued to s er ve a s a b eacon for c red ible research through its journals. Going for wa rd, A A PS has commit ted to further building its online presence t h rou gh v i r t u a l e vents a nd ot her tools to support scientists around the world, even as NBC and PharmSci 360 resume meeting in person. BioPharm: What initiatives are planned for 2022? M o r r i s ( A A P S ) : A A P S w i l l d e l i v e r a ho s t of prog r a m s b ot h online and in-person in 2022—but the biggest changes the organization is making are internal. In response to it s 2 021–2 02 6 St r ateg ic P l a n , A A P S h a s s e ate d ne w v olu nte e r committees that will address diver- sity and equity for members; sharpen the organization's scientif ic focus; and plan for the future with atten- tion to global growth and members' professional and scientif ic develop- ment. After months of investigation and discussion, the committees will deliver highly anticipated reports to the Board of Directors in 2022 that will lead to new programs, targeted at tent ion in ke y a rea s of sc ience, and a more welcoming and inclusive organization. BioPharm: Does A APS have any new publications planned for 2022? Morris (A APS): T he pha r ma- ceutical science community can look for ward to even more career-build- i n g c ont e nt p u bl i s h e d i n A A P S Newsmagazine throughout 2022 as it aligns with A APS' new program- m ing approac h: t he Fou r Seasons of Science. In the spring, the focus will be on biotechnology and NBC; the summer will bring the Land O' L a k e s C on ference s a nd at tent ion to bioana ly sis and pha rmaceut ica l analysis; the autumn will lead into the 2022 PharmSci 360 in Boston; and the winter will feature upcom- ing workshop topics and some of the yea r 's most popu la r webina rs a nd eChalk Talks. INCREASING KNOWLEDGE ABOUT EXCIPIENTS I P E C -A m e r i c a s h a d a p r o d u c - t i v e 2 021, i nt ro duc i n g t he y e a r- rou nd v i r t u a l tec h n ic a l /sc ient i f ic platform, Excipient World Academy, w h i c h o f f e r s e x t e r n a l w e b i n a r p r e s e nt at ion s a n d t r a i n i n g. T h e o r g a n i z a t i o n a l s o c h a n g e d i t s eLearning program to accommodate more virtual learning. I n a d d it ion to it s e d u c at ion a l p r o g r a m s , I P E C ' s E x c i p i e n t Qualif ication Committee addressed responsible sourcing in 2021 w ith the development of a fourth section to the I PEC Excipient Information Package (EIP) Guide. The organiza- tion also worked with toxicologists around the world to update the soon to be published IPEC Safety Guide for Pharmaceutical Excipients. B i o P h a r m I n t e r n a t i o n a l a s k e d K im Bea ls, E xecut ive Director of I PEC-A mer ica s, how COV I D -19 impacted IPEC-A mericas in 2021 a n d w h a t t h e o r g a n i z a t i o n h a s planned for 2022. BioPharm: How has COV ID-19 impacted IPEC training and work- shops? How ha s t he org a n iz at ion worked to resolve the impact? B e a l s ( I P E C - A m e r i c a s ) : A l t h o u g h t h e I P E C -A m e r i c a s E xc ipient L ea r n ing L ab ha s pro- v i d e d w e bi n a r s , w o r k s h o p s , a n d eLearning courses for several years, the number of webinars hosted by I PE C-A me r ic a s a l mo s t dou ble d , increasing from eight in 2019 to 17 each in 2020 and 2021. The biggest challenge was transitioning in-per- son work shops and brea k-out ses- sions to remote learning. However, w ith the ava i lable plat forms (e.g., Z oom) a nd tools (abi l it y to place attendees into separate rooms), we qu ick ly t ra nsit ioned a nd adapted, t hus st reng t hen i ng ou r abi l it y to deliver more remote training. BioPharm: What initiatives are planned for 2022? Beals (IPEC-Americas): A fter celebrating our 30th anniversary this year of being the go-to organization for excipients, IPEC-Americas plans to continue to develop and promote excipient best practices through webi- nars, trainings, and col laborations with regulators and other organiza- tions. In addition, IPEC has part- nered w it h [t he Produc t Q ua l it y Research Institute] PQRI to provide a continuous manufacturing workshop in Q2 2022 and is currently work- ing with members of other regional IPECs to initiate a cross-functional/ cross-regional team to address emerg- ing concerns for the use of nanomate- rials. IPEC-Americas also has plans to further strengthen existing rela- tionships with regulators and other pharmaceutical industry stakeholders in Latin America. BioPharm: W hat c a n you tel l u s a b o ut a ny ne w I PE C r e p or t s planned for 2022? Beals (IPEC-Americas): Plans are underway to publish two revised guides (General Glossary of Terms and Regulatory Sourcebook Industry Perspectives

Articles in this issue

Links on this page

Archives of this issue

view archives of BioPharm International - October 2021 - BioPharm-October 2021-Regulatory-Sourcebook